welcome to your 2008 spring edition! · awarding of two $500 training scholarships and two $1,000...

Volume 19, Issue 1 March 2008

A Publication of the North Carolina Chapter of the Society of Quality Assurance

Welcome to your 2008 Spring edition! The outgoing President’s message from Stu Mertz Page 2 The Incoming Presidents Message from Marcella Sarzotti-Kelsoe Page 4 Announcing the first Program for 2008 Page 6 Issues and Methods Calendar for 2008 Page 7 Introducing The New NCCSQA Publicity Committee Page 8 Your Executive Council Page 9 See and Hear your Executive Council at Work 0 NCCSQA Bylaw Amendments Approved Page 11 A Message from the Editor Page 12 NCCSQA Issues and Methods Roundtable; Disaster Recovery and Business Continuity Page 13 RQAP GCP Examination Information Page 15 RQAP GLP Examination Information Page 16 Opportunities Page 17 Corporate Sponsors Page 29 NCCSQA Application Page 32

QA Communiqué March 2008

The Past President’s Message by Stu Mertz

Local News.

Using new, web-based electronic voting software at SQA HQ, 77 members of NCCSQA elected an energetic and talented group of new Officers and Directors. Please join the Executive Committee in giving a warm welcome and thanks for their generously agree-ing to run in this election and serve us in 2008-2009:

!" President-Elect, Michelle Holbrook (Kendle International) !" Director, Evangelia Evdaimon (InfoStrength, Inc.), and Issues

and Methods Chair !" Director, Beth Furr (Quintiles Transnational Corp.), and Bylaws

Chair !" Director, Tabitha Westbrook (Copernicus Group IRB), and Pro-

gram Co-Chair 2007 had many significant accomplishments in service to our mem-bership including: !" Four excellent quarterly Chapter meetings plus a special EPA

meeting !" Ten monthly Issues and Methods roundtables !" Awarding of two $500 training scholarships and two $1,000 atten-

dance scholarships for SQA national meeting !" Eleven Executive Council meetings !" Three QA Communiqué Newsletters !" RQAP-GLP course materials distributed by emails !" Two posters at SQA Annual Meeting !" Full utilization of new and free SQA Administrative Services to

Chapters for managing our financial accounts, membership drive and database, quarterly meeting registrations, informational emails and web-based voting

!" Free Ads and Job Postings on website www.nccsqa.org !" Corporate Sponsors providing funding or in-kind services


The Past President’s Message..Continued by Stu Mertz

National News. In the SQA elections, our Treasurer Jeanne deWard (Charles River Laboratories) was elected to membership on the Edu-cation Committee. And former President of NCCSQA and SQA Past President, Patricia O’Brien Pomerleau (The Hamner Institutes, for-merly CIIT) was appointed by SQA to represent the CRO perspective on SQA’s Task Force on FDA GLP Modernization. Many thanks to the SQA Board of Directors and Headquarters Staff for the very wonderful Administrative Services provided via HQ Staff to NCCSQA in 2007! MANY! THANKS! to all our 2007 Chapter Officers and Directors who served so faithfully and to all our Chapter members who par-ticipated so enthusiastically. On January 1st, the gavel passed to our outstanding incoming President, Dr. Marcella Sarzotti-Kelso (Duke University) and her experienced Executive Council. Good Luck! And..Congratulations to Guy Gardner, RQAP-GLP (GSK), who is now the Chair of the SQA Council on Professional Registration. Year 2008 is the 10th Anniversary of NCCSQA as a Chapter of SQA –

are you ready to celebrate? Our working and serving together will make it another banner year!

Be GREAT in 2008! Stu Mertz


The President’s Message by Marcella Sarzotti-Kelsoe

First and foremost I wish to share with you my excitement for being the 2008 NCCSQA President. I will do my very best to provide lead-ership and support to the NCCSQA Chapter, on the year of its 10th Anniversary. Our 2007 President, Dr. Stu Mertz was an inspiring ex-ample for me last year and I greatly appreciated his support during the organization of the GCLP Workshop in October 2007. He will con-tinue as Past President this year. The Chapter elected a lively and competent group of new and returning Officers and Directors and we welcome all of them: Michelle Holbrook, President-Elect (Kendle In-ternational); Jann Sorrell, Secretary (Glaxo-SmithKline); Jeanne de-Ward, Treasurer (Charles River Laboratories Pathology Associates); Dr. Richard Patterson, Membership (R J Patterson & Assoc.); Beth Furr, By-laws Chair (Quintiles Transnational Corp.); Angela Berns, Publicity and Website Liaison (Schwarz Biosciences); Anita Simkins, Program Chair (Alphavax), Tabitha Westbrook, Program Co-Chair (Copernicus Group IRB), Evangelia Evdaimon, Issues and Methods Committee Chair (InfoStrength, Inc.). Last year you received a number of new services offered by SQA, which will continue in 2008: the ability to pay for Chapter quarterly meetings by credit card, and for membership in both organizations at the same time. SQA will do our accounting, maintain our membership database and send our Chapter notices via email. As a member of NCCSQA, you will receive the QA Communique newsletter each quarter, a discount for meetings registration and the opportunity to be part of an active group of quality assurance professionals. An increase in membership fees to $25 for 2008 was necessary to absorb the cost increase for all of the activities provided to members.


The President’s Message..continued by Marcella Sarzotti-Kelsoe

2008 promises to be an exciting year for NCCSQA. Two major activi-ties have already been planned. The first quarter GCP Training Pro-gram, to be held on April 3rd, will focus on translations of clinical documents and on ethics/compliance issues in the pharmaceutical R&D fields. The SQA Board has tentatively selected Oct 14-16, 2008 in Raleigh for the SQA Quarterly Board Meeting, to be held in con-junction with the NCCSQA Quarterly Chapter Meeting and celebra-tion of NCCSQA’s 10th Anniversary as a Chapter. During this meeting we will give you an update on the progress made by the organizers and the panelists of the GCLP Workshop held in Raleigh on October 2007 on the Whitepaper preparation. Finally, the Issues and Methods Sessions have already started and promise to be very engaging this year. I hope to see many of you at the Annual SQA meeting in Memphis during the week of April 20th. In a few days we will know who is the fortunate recipient of the NCCSQA Scholarship to attend the SQA meeting. You can come visit me at the NCCSQA poster. Please feel free to forward any suggestion and comment to the Execu-tive Committee Member closer to you or to me directly and we will try our best to accommodate your requests.

As we say in Italy…Buona fortuna per il 2008! (Good luck for 2008!)

Marcella Sarzotti-Kelsoe


The program committee is very excited about the first program of 2008 and is busy working on other programs tentatively scheduled for the year as follows:

2Q Meeting = Quality Manuals and Quality Agreements (Tentatively scheduled for July 17th) 3Q Meeting = NCCSQA meeting in conjunction with Society of Quality Assurance (An Update of

the GCLP whitepaper will be provided) 4QMeeting = Conflict and Resolutions for QA Professionals

Special Program = The Programs chairs are also working on another special program just for NCCSQA members.

If you would like to be a member of the Program Committee and assist in the planning of the up-coming programs please contact Anita Simkins at [email protected] or 919-595-0377 or

Tabitha Westbrook at [email protected] or 919-465-4310 ext. 174.

Announcing the first program for 2008!!!! The first NCCSQA program will be held on April 3, 2008 from 8:00am to 2:00pm at the Copernicus Group IRB Building at 1 Triangle Drive, RTP NC 27709. The schedule of events is as follows:

8:00am – 8:30am

Registration

8:30am – 8:45 am

Welcome and NCCSQA Business

8:45am – 9:45 am

Translation Process and Discussion of the EU Guidance Document on Translations presented by TransPerfect repre-sentatives, Jin Lee, Group Director; Daniel Milczarski, QA Director; Christy Fitch, Team Lead, Life Sciences; Chris Myers, Executive Quality Manager, Life-Sciences

9:45am – 10:00am

Break

10:00am – 11:00am

Translation from the Clinical Perspective presented by Charlotte Coley, Director of Duke IRB Education Programs

11:00am – 12:00pm

Indemnification presented by John Goodacre, General Counsel, Quintiles

12:00pm – 1:00pm

Lunch and Networking

1:00 pm - 2:00 pm Ethics and Compliance for Pharmaceutical Research and Development presented by Diane B. Campen, PhD, Frogmore, Consulting, Inc.


Issues & Methods Schedule 2008 - Check the NCCSQA Website for the latest details!!

Date Topic Facilitator Coordinator

January 8 What’s my role? QA & Vendor Man-agement

Evangelia Evdaimon

Lisa Olson

February 12

Disaster Recovery Plans & Business Continuity – what to include, how to test them & What to look at as an audi-tor

Edie McMillan

Evangelia Evdaimon

March 11 Remote Audits – When are they ap-propriate?

Evangelia Evdaimon

Kimberly Boyette

April 8 Key concepts of an effective Change Management program

Austin Al-wood

Kimberly Boyette

May 13 Quality in small to medium size organi-zations – How much is enough

Jenny O’Brien

Evangelia Evdaimon

June 10 Quality Tools – What companies use, how they are used and how effective are they?

TBD Betty Hyatt

July 8 Auditing clinical trials when there are electronic records (could be electronic source, could be EDC) - what do you differently?

Lisa Olson Evangelia Evdaimon

August 12 When regulators don’t care to visit, how does QA maintains its influence

Austin Al-wood

Betty Hyatt

Septem-ber 9

Paper vs. E-Submissions. How to make a transition

TBD Edie McMillan

October 14

Project Management Techniques – Usefulness for Quality

Jenny O’Brien

Evangelia Evdaimon

Novem-ber 11

Building the “Perfect” QA professional – Training, Knowledge, Skills, Person-ality Traits ….

Betty Hyatt & Evangelia Evdaimon

Edie McMillan

Decem-ber 11

N/A N/A N/A


Introducing….The NCCSQA Publicity Committee

The first meeting of brand new NCCSQA Publicity Committee was held in Janu-ary 2008. Our new volunteers are Robin Inman (Regional Senior CRA PPD), Adrienne Ingram (Senior Clinical Quality Associate, Schwarz Biosciences) and Maria Samuel (Manager, Laboratory Compliance). Robin has volunteered to act as Website liaison, working with our webmaster An-drew to keep the NCCSQA website up-to-date and fresh! Robin will also assess the memberships and board members’ website needs and to communicate with the webmaster. If you have any suggestions or comments, please be sure to communi-cate them to Robin. The website features details on upcoming events, roundtables and other events. Also, be sure to check out information on your Executive Coun-cil (EC) and Officers, a link to archived editions of the QA Communiqué, Oppor-tunities, Advertisements and our NCCSQA Sponsors. Please be sure to check out the members only section of the website ! Adrienne will be our Corporate Sponsor Liaison and will work with the EC to to solicit sponsorships for NCCSQA. Adrienne will also work with the treasurer to manage sponsorship payment has been received and ensure that the agreed upon language and logo are posted to the Sponsors’ webpage.

Maria as the Advertising Liaison. Maria has some exciting plans to advertise the NCCSQA and the workshops, events and roundtable's to a wider audience. We will be working together through 2008 to reenergise the Committee and improve the quality of the service for all our NCCSQA members.

I would like to thank Adrienne, Maria and Robin for so generously volunteering

their time and bringing a new sense of enthusiasm to our Publicity ventures!

Angela Berns, Publicity Director and Committee Chair, Newsletter Editor


2008 NCCSQA Executive Council

Officers Name Phone Fax E-mail

President Marcella Sar-zotti-Kelsoe, Ph.D.

919-684-6373 919-684-4288 [email protected]

President-Elect Michelle Hol-brook 919-257-6670 919-257-6671

[email protected]

Secretary Jann Sorrell 919-483-4872 919-315-0969 [email protected]

Treasurer Jeanne deWard (919) 206-7005 (919) 206-7001

[email protected]

Past President Stuart Mertz, Jr., Ph.D. 919-602-8568

919-462-0724 (phone first)

[email protected]

Directors

Membership Chair Richard Patter-son, Ph.D. 919-846-3832

919-342-6387.

[email protected]

Publicity Chair Angela Berns 919-767-2662 919-767-2517 [email protected]

Issues and Methods Chair

Evangelia Evdai-mon 919-313-3979 919-3979

[email protected]

Program Co-Chair Anita Simkins 919-389-7313 call first [email protected]

Program Chair Tabitha West-brook 919 201 1136 919 465 4311 [email protected]

Bylaws Chair Beth Furr 919-998-2563 919-998-1415 [email protected]

Publicity Commit-tee

Committee Chair, Newsletter Editor Angela Berns 919-767-2662 919-767-2517 Angela.Berns@ucb-

group.com

Corporate Sponsor Liai-son Adrienne Ingram 919-767-3218 919-767-3174 adrienne.ingram@ucb-

group.com

Website Administration Robin Inman 919-859-9493 919-654-5583 [email protected]

Advertising Liaison Maria Samuel 919-294-7164 919-294-7035 [email protected]


See and Hear your Executive Council at Work! The NCCSQA Executive Council meetings are open to all members. The Council meets 11:00 am - 1:00 pm on the second Thursday of every month at the GSK Venture Center, Durham NC. To comply with the security rules of our site host, please let us know of your intent to attend via email to NCCSQA Secretary Jann Sorrell by 5pm one week prior to the meeting. If you have items you'd like to add to our agenda, you may send them to Marcella at [email protected] The remaining meeting dates for 2008 are: 13 March; Notify by 07March 10April: Notify by 04April 08 May: Notify by 02May 12June: Notify by 06June 10July: Notify by 04July 14 Aug; Notify by 07 August 11 Sep; Notify by 05 September 09 Oct; Notify by 03 October 13 Nov; Notify by 07November 11 Dec; Notify by 05 December


NCCSQA BYLAW AMENDMENTS APPROVED All proposed amendments to the NCCSQA Bylaws were overwhelmingly approved in November by the membership. The NCCSQA Bylaws incorporating these amendments will be available to members on the NCCSQA Website. The voting results for each proposed Bylaw Amendment are below.

Article V, Section 7: Election of Officers and Directors Elections shall be held annually with voting accomplished by the use of mail or electronic ballots. In the event of a tie, the President shall call a meeting of the Chapter Executive Council and the tie shall be resolved by a majority vote of the Chapter Executive Council. Yes: 77/No: 0

Article VI, Section 5: Administration The Treasurer shall be the custodian of all monies and dues of the Chapter and shall pay all authorized bills against the Chapter. The Chapter Executive Coun-cil shall authorize the disbursement of all funds except that the Treasurer may make disbursements of $500.00 or less after receiving a proper invoice or re-ceipt. The Treasurer shall prepare monthly reports for the Chapter Executive Council unless some other reporting period is proscribed by the Chapter Execu-tive Council. The Treasurer shall submit the accounts for audit each year by a company or persons designated by the Chapter Executive Council. The Treasurer shall transmit to the successor in office all funds and property of the Chapter held by the Treasurer. An annual report shall be submitted to the Chapter in such form as may be determined by the Chapter Executive Council. No funds shall be expended by or in the name of the Chapter to the extent that the expendi-ture, if made by the Society of Quality Assurance, would represent use of funds for a purpose or for purposes not within the Society’s exempt purposes under Section 501(c) 6 of the Internal Revenue Codes. Yes: 76/No: 0

Article VII, Section 3: Meetings If decisions are to be made or votes to be taken on official Chapter business at a special meeting, a quorum consisting of 20% of the Chapter members in good standing is required. Alternatively, decisions can be made by mail or electronic ballots. Yes: 77 No: 0

Article XI, Section 1: Amendments Amendments to these Bylaws may be presented by any member in good standing at any regular meeting of the Chapter or to the Chapter Executive Council by the Bylaws Committee. The Chapter Executive Council and Bylaws Committee will review pro-posed or perfected amendments to ensure that amendments do not conflict with Chapter objectives. Any amendment agreed upon by both bodies is presented in writing to the Chapter membership by mail or electronic ballot. A simple majority vote of ballots received within 30 days of distribution shall be necessary to adopt any amendment. The results of the Bylaws amendment will be announced at the next Chapter meeting. Yes: 77/No: 0


A Message from the Editor

I hope you are all having a wonderful spring! Do you feel like a budding author? Was one of your New Years Resolutions to become published? Well, why not start with an article or submission to our very own QA Communiqué? Please remember that we are delighted to publish all member news, articles, open positions and accomplishments. Feel free to e-mail me at [email protected] for more infor-mation.

The deadline for contributions for the 2nd Quarter Summer Newsletter is 27 June 2008. We are also accepting all contribu-

tions for the Fall and Winter editions

MEMBERSHIP NEWS From Rich Patterson... NCCSQA Membership Chair The 2008 NCCSQA membership is 191 members. This is 19 members more than last month. Last year at this time we had 168 members. 92 of our members indicate expertise in GLPs and 58 indicate expertise in GCPs. There are 16 members who have expertise in both.


NCCSQA Issues and Methods Roundtable – 12 February 2008 NCCSQA Roundtable Meeting Minutes Topic: Disaster Recovery Plans & Business Continuity

– What to include, how to test them & what to look at as an auditor Facilitator: Evangelia Evdaimon & Lisa Olson

Attendees of February’s Issues and Methods roundtable discussed responsibilities, communication, testing, verifica-tion, and auditing associated with disaster recovery and business continuity plans. A summary of the discussion is provided below. DEFINITIONS from various sources: Disaster - a sudden event, such as an accident or a natural catastrophe, which causes great damage or loss of life. A disaster may also be viewed as any interruption to normal work processes. Disasters include tornado, flood, hurri-cane; fire; terrorism; computer virus; human error; widespread illnesses; loss of key personnel; or an event that threatens the reputation of the company. Disaster Recovery Plan (DRP) – processes, policies, and procedures, which prevent or minimize the effects of a disaster and allow the organization to maintain or quickly resume critical functions. The plan outlines steps for re-gaining access to data, communications, workspace, and other business processes. Business Continuity Plan (BCP) – practiced logistical plan to recover and restore partially or completely inter-rupted critical functions within a predetermined time following disruption of those functions. Often the terms DRP and BCP are used interchangeably. In some organizations a DRP is associated with IT depart-ments while a BCP has a larger scope and is associated with senior management groups. In the latter case a DRP becomes a subset of the BCP. DRP/BCP RESPONSIBLE Party/Parties vary by company: Those responsible for reviewing and maintaining the plan as well as key decision makers need to be identified. The best model observed by one consultant is a team representing all departments. Two additional models mentioned were IT & Upper Mgmt, and Facilities, IT, & QA. QA should not own the DRP. CONTACT Information: A chain of command is needed to clearly define who has authority to make decisions in the event key personnel are unavailable. Communication during a disaster is of paramount importance, requiring call list information to be complete and accurate. Contact names, phone numbers, and addresses should be verified and updated on a periodic basis. Audits have uncovered out of date call list information. NOTIFICATION Information should be communicated by predetermined channels and in a predetermined time frame. The nature/severity/publicity of the event will impact the flow of information from specific company personnel to specific busi-ness partners, suppliers, contractors, customers and the media. Even communication as to what is not effected can be important in maintaining customer confidence. Disaster Recovery Plans & Business Continuity CONTINUED ON NEXT PAGE….


Disaster Recovery Plans & Business Continuity CONTINUED…. TESTING A subset of the plan or the whole plan can be tested. Testing can be announced or unannounced, however documen-tation from planned tests is usually more complete and therefore planned tests are recommended. Screen captures are recommended for documentation purposes; written comments such as “testing complete” is not sufficient. A scenario test approach may be used: scenario X just happened, now what? Emergency power sources should be tested. Smaller GMP companies may schedule testing during off peak hours. Should main or backup systems be tested? Do back up systems have the adequate capacity to handle data? Testing the main system may have a perceived higher risk, however in not testing the main system one does not know if it can be brought back. Test systems by deleting a file, confirm deletion, and then restore file. Disk to disk backup is more reliable than tapes and may be retrieved within seconds to minutes. Mirroring (use of two servers) is a good approach. Divert files to different sites, preferably geographically different sites. Use off-site fail-over servers. VERIFICATION What type of verification should be performed? Is the content checked and all data found to be complete and accu-rate? Sampling or statistical sampling is usually employed. PROCEDURES For GMP operations, SOPs can include direc0tions to manually document a manufacturing process in the event electronic batch record systems become unavailable. PAPER TRAIL Documentation during a disaster is critical. Document everything and follow procedures. Include conclusions and preventative actions in write-ups. Some firms maintain hard paper documents in fireproof cabinets on site with a retention schedule for moving docu-ments off site. Others maintain electronic files and readers. Scanning and saving files in PDF format is recom-mended. AUDIT Look at overall controls and audit against procedures/policies/plan. Read test records and check for extensive docu-mentation of tests such as screen captures. Check backup documentation. Auditing is a matter of risk assessment. As an auditor, ask sponsor to define scope/depth based on time and re-source constraints. CONVINCING MGMT Management may be hesitant to provide resources necessary for establishing DRPs and BCPs. Regulatory require-ments and customer expectations for such plans need to be communicated and risks for not establishing plans docu-mented. PERIODIC REVIEW Plans are normally reviewed annually or at times of change. Some firms review plans more frequently.


GOOD CLINICAL PRACTICES (GCP) Dear NCCSQA Members planning to take the RQAP-GCP exam on Saturday April

19, 2008:

http://www.sqa.org/newsite/cpr/rqap-exam-gcp.asp

The NCCSQA RQAP-GCP Exam Study Program for 2008 consists of coordinating the exchange of email addresses of persons interested in getting together for private

group study.

You must be dues paying 2008 member of NCCSQA to participate in this pro-gram.

If you are interested and willing to let us share your email address with the

other April GCP exam registrants, you can communicate separately with them and you may be able to set up a study group or study buddy on your own to prepare for

the exam.

To participate in the 2008 NCCSQA RQAP-GCP Exam Study Program, send an email to [email protected] with your name and in subject line enter the follow-ing: "RQAP-GCP Exam" if interested in sharing your email for private group

study.

I will send out the list of participants on Monday, March 24th.

Thanks for your interest and Good Luck on the exam!

Stu Mertz, Past President NCCSQA

RQAP-GCP Exam Information


RQAP-GLP Exam Information

GOOD LABORATORY PRACTICES

Dear NCCSQA Members planning to take the RQAP-GLP exam on Saturday April 19, 2008:

The NCCSQA RQAP-GLP Exam Study Program for 2008 consists of two parts: 1. Exchanging email addresses of persons interested in getting together for private group study. 2. Distribution of 11 emails containing files of study materials developed for 2006 study program.

You must be a dues paying 2008 member of NCCSQA to participate in this program

To participate in the 2008 RQAP-GLP Exam Study Program, please send an email to [email protected] with your name and in subject line enter one of the following

three choices:

1. "RQAP-GLP#1only" if only interested in sharing email for private group study 2. "RQAP-GLP#2only" if only interested in receiving 11 emails with 2006 study materials 3. "RQAP-GLP#1&2" if want to participate in both activities

If you are interested and willing to let us share your email address with the other April GLP exam registrants, you can communicate separately with them and you

may be able to set up a study group or study buddy on your own to prepare for the exam.

I will send out the list of persons and emails starting on Monday, March 24th. Thanks for your interest, Stu Mertz, Past President NCCSQA RQAP-GLP Ad hoc Materials Distribution Committee: Stu Mertz & Carrie Ingalls


Frankel Staffing Partners is working on a new Contract opportunity for a Biotech in the Durham, NC area. The position will last for 4 months, maybe longer, and is paying

$18-20.00 an hour. If you are interested in discussing, please forward your Word re-sume to [email protected]. If not, please feel free to pass onto colleagues

who may be interested. GMP Document Control experience in the industry is re-quired.

GMP Document Specialist

Responsibilities:

Maintain master and control records Exercise judgment within generally defined practices and policies in selecting

methods and techniques for obtaining solutions Enforce procedures governing document management

Conduct training on document management procedures, as applicable Perform non-technical review of documents

Word process documents as required Respond to requests (i.e., document information copies, problem solving, and gen-

eral information pertaining to document management) Issue Batch Production Records, issue labels for study kits and vaccine shipments,

issue final product labels and reconcile returned labels Normally receive no instructions on routine work and general instructions on new

assignments Perform other reasonable, related business duties

Thank you,

Jessica Lyon

Senior Recruiter

Frankel Staffing Partners [email protected]

www.frankelstaffing.com

Opportunities. Please see www.nccsqa.org/opportunities for the latest advertisements


GCP Quality Auditor - Pharmaceutical, Direct Hire:

Our client, a pharmaceutical firm located in Research Triangle Park, is actively recruit-ing for a GCP Quality Auditor to join its rapidly expanding Quality Assurance

team. The Firm is experiencing tremendous growth and is eager to bring on a top-notch clinical professional for a key role handling its GCP function. This position is a direct

hire position, will require 50% travel and is paying up to the mid $80’s plus bonus, benefits, etc.

The selected candidate will conduct clinical site, file and/or data audits to ensure com-pliance with GCPs, SOPs, cGMPs and other applicable regulatory requirements. In ad-dition, this person will prepare audit reports and corrective action plans, coordinate au-dits, review (QC) internal documentation for compliance to Company SOPs, GCPs and other applicable regulatory requirements; assist in the preparation for and execution of international or domestic regulatory agency inspections; develop, implement and revise Quality Assurance SOPs; and perform other tasks as assigned by management person-

nel.

The ideal candidate will have 2-5 years of experience in clinical research and/or the pharmaceutical industry and have at least 1-2 years of experience conducting GCP au-

dits. RAC &/or CQA certifications a plus.

Please forward resumes to [email protected] Frankel Staffing Partners

(919) 783-6300 www.frankelstaffing.com



Our client, a thriving pharmaceutical firm in the RTP area, has an immediate need for a seasoned Manager of Clinical Quality Assurance to support implementation and management of the R&D

GCP, GLP & GPvP Quality Systems. The ideal candidate will be a dynamic leader that will thrive in a fast paced and growing setting.

Duties will include – Developing the QA R&D audit strategy for GCP & GPvP in line with the Global R&D QA strat-

egy. Ensuring that all Company clinical trials are carried out in accordance with corporate and statu-

tory regulations. Promoting and advancing quality awareness throughout the R&D organization.

Implementing the R&D audit program to support GCP, GPvP, business and regulatory require-ments.

Responsible for managing GCP & GPvP QA in RTP. Supporting the implementation of the technical training program that operates at the RTP site. Reporting of critical GCP, GLP & GPvP non-compliance to Senior Global Director R&D GCP

QA and collaborating with Corporate Compliance for Corporate Compliance Inspections. Managing R&D GCP & GPvP QA resources in Due Diligence (DD) audits.

This is a fast-paced, highly empowered setting. Company is seeking a sharp, capable person who thrives in such a setting. Compensation will be generous. Advanced degree is strongly preferred and a minimum of 5-8 years of QA and proven auditing experience across a full range of clinical audit types including CROs, Investigator sites, protocols, clinical study reports, systems and sub-

missions is a must, plus proven management experience, minimum of 2-3 years.

Relocation assistance will be provided for out of state candidates.

Please forward Word resumes to [email protected] for consideration.

Jessica Lyon Senior Recruiter

Frankel Staffing Partners Main (919) 783-6300

[email protected] www.frankelstaffing.com

Opportunities...see www.nccsqa.org/opportunities for the latest advertisements


Our client, a thriving pharmaceutical firm in the RTP area, has an immediate need for a seasoned Preclini-cal Quality Assurance GLP Associate to ensure all pre-clinical trials are carried out in accordance with

Corporate and statutory regulations. The ideal candidate will be a dynamic self starter who will thrive in a fast paced and growing setting.

Duties will include –

Promoting and advancing quality awareness throughout the R&D organization.

Developing and managing the R&D QA GLP audit program.

Supporting implementation and management of R&D GLP Quality Systems.

Supporting implementation of Global R&D QA strategy and collaboration with peers.

Supporting the implementation of the GxP technical training programs that operates at the RTP site.

Report critical GLP non-compliance to Director R&D GCP QA and supporting Corporate Compliance Inspec-tions

Support R&D GLP activities.

Perform internal and external audits in line with GLP regulations and laws.

This is a fast-paced, highly empowered setting. Company is seeking a sharp, capable person who thrives in such a setting. Compensation will be generous. 4 year degree is strongly preferred and a mini-mum of 2-4 years of QA and proven auditing experience across a full range of pre-clinical audit types in-

cluding facilities, animal studies, reports etc. is a must, as well as full knowledge of GLP requirements and audits. GCP knowledge is a plus.

Travel will be under 40%. Relocation assistance will be provided for out of state candidates.

Please forward Word resumes to [email protected] for consideration.

Jessica Lyon Senior Recruiter

Frankel Staffing Partners Main (919) 783-6300

[email protected] www.frankelstaffing.com

Opportunities.


Our client, a global pharmaceutical company located in the Research Triangle Park area, is actively re-cruiting for a highly competent, knowledgeable and operationally-savvy Quality Assurance expert for key role driving GMP Quality efforts for the Company’s R&D program. Company is undergoing tremendous expansion. Processes and procedures from the past no longer apply. Seek a builder and an innovator who, in collaboration with partners/colleagues internationally, will develop the Company’s R&D Quality Assurance program for its future. Specific responsibilities will include: !Implement and manage the R&D GMP Quality System in collaboration with Global R&D, QA and Corpo-rate Business strategy. Ensure Company Drug Product / clinical trials supplies production is carried out in accordance with corporate and statutory regulations. !Direct the R&D GMP (internal and external) audit program to support business and regulatory require-ments. Ensure new CMOs are assessed for GMP compliance and certified prior to supply of services and or goods. Ensure Approved API and excipient supplier program is established and managed in accordance with Company and regulatory standards. !Develop and implement a system to manage R&D change control, OOS’s and deviations !Approve batch analytical and manufacturing records. Authorize release of Clinical Trial supplies. !Develop and manage a system that ensures that the Company’s documentation is complete, monitored, accurate and current. Documentation will include: Specifications, Validation protocols, test scripts & re-ports, Analytical Methods, Formulation Reports, Stability Protocols and Reports, Technical and Clinical Study reports, etc. !Assure appropriate standards are applied to support R&D IT, cleaning, equipment and method validation activities. !Host and coordinate all aspects of FDA (and other) inspections/audits. Effectively lead and manage a productive and respected QA team. Support technical training initiatives. Contribute towards building a Quality mindset throughout the local and global R&D organization. Specific qualifications will include: !BS degree in scientific field (Advanced degree and/or Quality certification preferred). !12+ years in pharmaceutical QA (GMP focus) including 8+ years in leadership role. !Extensive background in Research and Development including broad usage of third party vendors. Ex-perience in pilot plant set up. !R&D Product Development experience in Rx topicals, solid dosage forms, liquids, sterile injectables, tab-lets and biologics. OTC/generics a plus. Experience leading regulatory inspections including hosting, follow up and close-out. Selected candidate will be a seasoned QA professional who offers demonstrated success assuming similar role in a globally-minded, highly-collaborative setting. Deep and broad knowledge of Quality regulations and practices are critical (and assumed). Beyond the technical capabilities, company seeks a hands-on and impactful leader with impressive track record of developing and implementing policy and procedure--in response to growth. Seek a leader who thrives in an evolving setting. Further, seek candidate who has an impressive history of driving a Quality practice while developing positive relationships with other operat-ing units/departments. Relationships are important. Company is prepared to pay top dollar to attract and retain its candidate. Full relocation is available. In-terested and qualified candidates should forward Word resume to [email protected] for immediate reply.

Opportunities.


Our client, a large and expanding global pharmaceutical company with R&D headquarters in Research Triangle Park, is actively recruiting for a highly competent, seasoned and versatile Quality Assurance expert for key role lead-ing Clinical Quality Assurance efforts. Company has multiple products on the market and many more in the pipeline. Seek smart, knowledgeable and influential leader to drive this critical function at this critical time.

Specific responsibilities will include: !" Implement and manage the R&D GCP, GLP & GPvP Quality System for North America in collaboration

with Global R&D, QA and Corporate Business strategy. !" Ensure all pre-clinical and clinical trials are carried out in accordance with corporate and statutory regula-

tions. Direct the R&D audit program to support GCP, GLP & GPvP business and regulatory requirements. !" Evaluate the Company’s and vendors’ quality systems and procedures, particularly in the Chem & Pharm

and Clinical Research Department. Contribute towards the development of a Best Practices Quality Pro-gram.

!" Assess non-conformities/non-compliant findings. Ensure appropriate actions are agreed upon and handled. Implement and manage R&D CAPA system.

!" Ensure new contract organizations and clinical supply vendors are assessed for GCP, GLP & GPvP compli-ance and certified prior to supply of services and or goods.

!" Host and direct Company’s efforts during regulatory and other inspections. !" Develop and manage the Clinical Quality team. Promote and advance quality awareness throughout the

organization. To successfully produce in this highly dynamic, largely outsourced and rapidly-expanding global operation, the Di-rector must complement broad and deep knowledge of GCP regulations and practices with a hands-on, makes-things-happen management style, astute operational/logistical savvy and seasoned people management skills. This is a global operation with remote staff and colleagues. Third party vendors are employed for numerous functions. Suc-cessful candidate will offer demonstrated ability to successfully lead in a similarly complex setting.

Specific qualifications will include: !" BS degree in scientific field (Advanced degree and/or Quality certification preferred). !" 12+ years in pharmaceutical/clinical QA including 8+ years in leadership role. !" Extensive auditing experience across full range of clinical audit types including CROs, Investigator sites,

protocols, clinical study reports, systems and submissions. !" Experience leading FDA and regulatory inspections in the role of host including follow up and close-out. !" Full knowledge of phase I – IV studies, bioanalytical, PK skin, blood/urine lab analysis. !" Knowledge of drug(Rx, OTC), biological product and medical device studies. !" Knowledge of Pharmacovigilance and GLP a plus Company hires top-of-the class employees and seeks a leader who will set an example. Company is prepared to pay top dollar -- designed to attract and retain. Interested and qualified candidates should forward Word resume to [email protected] for immediate reply. Lee Frankel Frankel Staffing Partners [email protected] www.frankelstaffing.com

Opportunities


Director of Regulatory Affairs

Location: Research Triangle Park, NC Our client is an innovative biomaterial-based medical devices company whose products are changing the way physicians practice medicine today and in the future. As the Director of Regulatory Affairs, you will

have a frontier opportunity to: Generate company regulatory strategies

Rapidly introduce new products nationally and abroad Support ongoing commercialization from a Regulatory perspective

Work closely with functions within the parent organization, other marketing partners, key opinion lead-ers in target therapeutic areas, and other medical device and discovery RA organizations

This is an incredible opportunity for a Regulatory Affairs professional to combine global regulatory experi-ence with innovation, leadership, discovery and marketing to make an individual impact on healing proc-

esses for millions across the globe.

*Highly competitive compensation package includes exceptional base plus a strong bonus structure dependent on annual individual contribution* Requirements:

BS in Science or related field. MS degree or higher is preferred. Minimum 8+ years of U.S and International Regulatory Affairs and Compliance is required. Minimum 8+ years experience in medical device and/or pharmaceutical/biologics development is re-

quired. 5 + years experience in Class III medical device regulatory management mandatory. Experience managing others is also required. Previous experience interacting with the FDA is a must. Up to 20% travel is required (domestic and international).

Responsibilities: Direct regulatory activities to develop and commercialize new medical devices and assuring company compliance to the design control requirements of 21CFR Part 820, ISO9000/ EN 46000, Medical Devices Directive 93/42/EEC, Japan’s PAL and all other global Regulatory Regulations for the manufacture and distribution medical devices. Develop comprehensive regulatory strategies for global approval of new CMC (chemistry manufacturing controls) products. Provide direction and guidance to R&D within organization on pre-clinical, clinical and regulatory re-quirements related to the development and maintenance of new CMC products. Obtain required regulatory approvals for initiation of clinical trials involving CMC products and assure regulatory compliance of the trials themselves. Define, communicate and assure completion of all regulatory requirements/documentation necessary to obtain marketing clearance or approval of CMC products in all identified global markets, including sub-mission of Pre-market Notifications (510k), Pre-market Approvals (PMA), Central European dossiers and International registrations/approvals (i.e. Canada, Japan, etc.). Assemble and maintain technical documentation for Central European marketing and Rest-of-World launch of company products. Assure all necessary regulatory interaction and documentation related to ongoing regulatory compliance of CMC products including the filing of periodic reports to regulatory agencies and device/facility listing/registrations.

Change the face of medicine. Apply now. As a professional search firm, we will only be responding to inquiries that most closely align with the requirements specified above. Please include position ID (CC 1104) in the subject line of your correspondence and forward your credentials in confidence as an attached Word document to [email protected].

Opportunities


Opportunities: Manager, Regulatory Affairs: Create Something Different

Client Description: Our client is a progressive medical technology firm whose focus in the field of personalized medicine, prospective health care, and disease risk assessment assists medical experts detect early onset of disease states and offer guidance in personalized treatment decisions. Our client develops a state-of-the-art tools that provide clinical decision support by identifying and leveraging the factors that predict a patient’s likelihood for experiencing disease or adverse events and the subsequent risk/benefit of alternate therapies. Opportunity Statement: The Regulatory Affairs Manager will be responsible for establishing the Regulatory Affairs function within this innovative, personalized healthcare organization. Our client’s products cross both device and diagnostic technologies and clinical software systems, posing unique regulatory challenges. This is an exciting opportunity for a motivated and proactive individual to drive documentation, policies and procedures that will govern future regulatory activities, as well as supporting ongoing regulatory submissions. If your interests include working with FDA to drive product direction and thinking within the Personalized Medicine space, this is your chance to take advantage of a ground floor opportunity with a venture-backed, emerging growth company, whose goal is the transformation of the $1.2 trillion health care industry. Responsibilities: !" Preparation of regulatory submissions (510(k) applications) for product registration and approval !" Participation on regulatory project teams !" Advise on and direct regulatory requirements !" Represent organization and interact directly with regulatory authorities and agencies !" Ensure regulatory compliance by review and approval of labeling, promotional materials and advertising !" Act as Regulatory Advisor, providing guidance and input to various functional groups within the organization Essential Requirements: !" Regulatory Experience with Devices or Diagnostics. !" Direct FDA interaction. Additional Requirements: !" Experience composing SOPs (Standard Operating Procedures) related to regulatory guidelines and compliance !" First authorship of regulatory submissions, specifically FDA submissions: 510(k) and 513(g), pre-IDEs, PMAs, etc. !" Professional network (contacts and relationships) to include current and former FDA personnel, and regulatory consultants and attorneys. Additional pluses: !" Regulated Software Experience. !" Familiarity with FDA guidance on In Vitro Diagnostic Multivariate Index Assays (IVDMIA) !" Work experience with legal counsel, product development, sales and marketing and other functional internal and external resources. !" Supervision of junior regulatory personnel. Prior work history and interest in driving novel technology with FDA. As a professional search firm, we will only be responding to inquiries that most closely align with the requirements specified above. Please include position ID (Regulatory Affairs Manager: CC 1146) in the subject line of your correspondence and forward your credentials in confidence as an attached Word document to [email protected].



Quality Assurance Auditor

Professional Laboratory and Research Services (PLRS) is a well-

established CRO in the field of veterinary medicine. PLRS is a recog-nized leader in veterinary medicine research providing customer focused

services to its clients for 22 years.

Full time QA position is available with benefits. B.S. degree in Biol-ogy or a related field, with previous experience with Good Labora-tory Practice (GLP) Regulations (2 to 5 years) preferred. Responsi-bilities includes auditing of studies (and facilities); pre-study proto-col reviews, developing auditing schedules, and maintains QA files, monitors clinical and non-clinical studies for compliance with GLP

and GCP regulations, standard operating procedures and study pro-tocols; audits data and final reports.

Computer literacy and generation of audit reports required along

with ability to work independently and meet project deadlines.

PLRS is located in Corapeake (northeastern North Carolina) within a short drive from the Virginia Beach/Norfolk Virginia metropolitan

area. Visit our website at www.plrs.com.

Send resume and salary history to [email protected]



Job Description Location: Charlotte, NC

Travel: None

At Accenture Technology Solutions (a wholly-owned subsidiary of Accenture), we look for people who en-joy technology challenges to help Accenture clients succeed. As part of our global team, you'll be working with the latest software and leading-edge development tools - giving you the opportunity to build specialist skills and expertise on the job. We need people who thrive on tough technology challenges. People who

can help turn innovative ideas into effective results.

If you’re looking for new and enjoyable work, this could be the place for you.

Job Description Testing professionals focus on testing computer hardware and/or software applications at various stages - unit, component, and systems level - during the overall development process. Individuals have deep skills

in testing cross-environment, using automated testing tools and languages.

Qualifications Basic Qualifications

• Minimum 3 years automated testing experience • Skilled in Mercury Testing Suite of products (LoadRunner, WinRunner or QuickTest Professional)

Preferred Qualifications

• Exposure and/or experience working with offshore resources a plus • Good technical documentation skills

This position offers: • Full time salaried position building deep technical skills

• Overtime pay • Little-to-No travel required

• A complete and competitive benefits package • Clear career track/Promotion opportunities

• Application Delivery and Professional Development training • Certification reimbursement program

If interested, please contact

Jason B. Pyron

Accenture Technology Solutions Recruiting - South Region [email protected]



Research Quality Assurance Specialist

RTI is an independent organization dedicated to conducting innovative, multidisciplinary research that improves the human condition. With a worldwide staff of more than 2,500 people, RTI offers innovative research and development and a full spectrum of multidis-ciplinary services. Universities in North Carolina founded RTI in 1958 as the first scien-

tific organization in and centerpiece of the Research Triangle Park.

RTI Health Solutions, a business unit of RTI International, is currently seeking to fill the position of Research Quality Assurance Specialist I within the Office of Quality Assur-

ance. This position will report directly to the Director, Office of Quality Assurance.

Responsibilities • Write Standard Operating Procedures

• Assist project teams with documentation • Conduct training on various QA topics for project staff

• Provide project teams with QA support • Conduct and document internal project audits and internal process audits

• Create, manage and track corrective and preventive action plans for both internal and external audits

Qualifications

• BS or BA degree, preferably in a scientific field, and at least six years of experience in a quality assurance function

• A solid understanding of FDA regulations and Good Clinical Practices (GCP) is re-quired

• The successful candidate must have excellent verbal and written communication skills • Candidate will be able to work well in a team environment as well as independently • Candidate will possess strong organizational abilities, and must demonstrate careful

attention to detail Please apply at www.rti.org/careers (Job ID 11280)

EEO


Manager, Regulatory Affairs: Next Generation Medicine RTP, NC

Opportunity Statement:

The Regulatory Affairs Manager will be responsible for establishing the Regulatory Affairs function within this innovative, personalized healthcare organization. Our client’s products amal-gamate device, diagnostics and clinical software systems, posing unique regulatory challenges. If your interests include working with FDA to drive product direction and thinking within the Personalized Medicine space, this is your chance to take advantage of a ground floor oppor-tunity with a venture-backed, emerging growth company, whose goal is the transformation

of the $1.2 trillion health care industry.

Responsibilities: !" Preparation of regulatory submissions (510(k) applications) for product registration and ap-

proval !" Participation on regulatory project teams (FDA, legal counsel, etc.)

!" Advise on and direct regulatory requirements !" Represent organization and interact directly with regulatory authorities and agencies

Ensure regulatory compliance by review and approval of labeling, promotional materials and ad-vertising

Minimum Requirements:

!" Regulatory Submissions Experience with Devices or Diagnostics. First authorship of regulatory submissions, specifically FDA submissions: 510(k)

and 513(g), pre-IDEs, PMAs, etc.

Additional Pluses: !" Experience composing SOPs (Standard Operating Procedures) related to regula-

tory guidelines and compliance. !" Familiarity with FDA guidance on In Vitro Diagnostic Multivariate Index As-

says (IVDMIA) and Model Based Diagnostic Strategies. !" Regulated Software Experience.

Prior work history in driving novel technology with FDA.

As a professional search firm, we will only be responding to inquiries that most closely align with the requirements specified above. Please include (Regulatory Affairs Manager: CC 1146) in

the subject line and forward your credentials in confidence to [email protected].

Change the face of medicine… Apply now.



Thank you To our Corporate Sponsors

!

!

!

!

!

!

Linda H. Borkowski- Regulatory Compliance Consultant

2824 Summerwind Road, Chapel Hill, N.C. 27516, (919) 967-3982

Linda H. Borkowski is an independent consultant with more than 25 years of experience in the pharmaceutical industry. She specializes in Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliance program development, auditing and training. Additional capabilities include SOP development, R&D Good Manufacturing Practice (GMP) auditing for clinical sup-

plies and R&D computer validation consulting.



Experimental Pathology Laboratories, Inc.

PO Box 12766 Research Triangle Park, NC 27709

PH (919) 998-9407 FAX (919) 998-9607

www.epl-inc.com

Experimental Pathology Laboratories (EPL®) provides contract histology and toxicologic pathology support in two laboratories near Washington, DC, and in Research Triangle Park, NC. Our pathol-

ogy services are provided by 25 experienced veterinary pathologists, most certified by the American College of Veterinary Pathologists. Technical and clerical staffs trained in reporting pathology data support these pathologists. EPL’s histology laboratories are staffed by highly qualified technicians, including certified Histologic Technicians. Our laboratories produce microscope slides from more

than 50,000 tissues per month. Among other services offered are immunohistochemistry and digital morphometry. EPL operates in full compliance with U.S. and International GLPs.



!

!

!

!

!

!

RTI International is one of the world’s leading research institutes, dedicated to im-proving the human condition by turning knowledge into practice. With projects in more than 40 countries and a staff of more than 2,600, RTI offers innovative re-search and technical solutions to governments and businesses worldwide in the ar-eas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, democratic governance, economic and social development, en-ergy, and the environment. For more information, visit www.rti.org.

RTI International is a trade name of Research Triangle Institute.


NNORTH

CCAROLINA CCHAPTER of the SSOCIETY of QQUALITY

AASSURANCE

OUR MISSION

To disseminate current informa-tion

on regulatory policies and trends, provide multifaceted educational

opportunities, and to act as a resource for our members who are respected quality assurance pro-

fessionals.

Please send this completed application with $25.00 dues to:

NCCSQA 2365 Hunters Way

Charlottesville, VA 22911

TIN # 56-1127594

2008 NCCSQA Membership Form Go to www.nccsqa.org for more information

Name: Title: Company: Address: City: State: Zip code: Telephone: ( ) Fax: (____) E-mail: New Member ____ Membership Renewal _______ Area of Expertise (you may select up to 2 categories): GLP GMP/QSR GCP 21 CFR Part 11 Arena: FDA Drugs EPA FDA Devices FDA Animal Health FDA Biologics International Regulations: (please specify) SQA Member: Active Affiliate Not Certifications: RQAP-GCP RQAP-GLP

CQA CQIA RAC Other (specify):

welcome to your 2008 spring edition! · awarding of two $500 training scholarships and two $1,000...

Documents