For more information please contact PharmigT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

An Introduction to Sterile ManufacturingWEDNESDAY 21ST amp THURSDAY 22ND OF APRIL 2021A VIRTUAL ZOOM EVENT SPLIT OVER TWO DATES

THE VOICE OF MICROBIOLOGY FOR 30 YEARS 1991 - 2021

bull Introduction to sterile manufacturing bull Introduction to microbiology bull Introduction to cleanrooms bull Methods of sterilisation

bull Process manufacturingbull Sterility assurance bull Sterile manufacturing and the regulations and

compliance to GMP

ldquo Thank you for all the work in preparing the presentations and presenting over the last two days It has been valuable learning and the feedback is very positiverdquo - HPRA

ldquoKeep up the good workrdquo - Sartorius

ldquo Excellent presentations amp organisation ndash really enjoyed itrdquo - MML

ldquo This was one of the most engaging virtual events I have attended so far Loved the variety of topicsrdquo - AstraZeneca

Do also take a look at Pharmig current publications outlined on pages 6 - 8 AND our interactive on-line training module on Cleaning amp Disinfection of CleanroomsOn page 9 you can view additional upcoming meetings amp webinars

Topics covered include

Pharmig lsquoVirtualrsquo Testimonials

Is this your first time receiving Pharmig info Would you like to continue to be updated on our meetings amp webinars etc If yes please click here to send your details

David is a microbiologist working for Ecolab as Director Pharmaceutical Microbiology in their Lifesciences division With reference to Pharmig ndash David became a Committee member in 2007 and in November 2013 he had the honor of being elected as Pharmig Chair

David started life at GSK Barnard Castle Here he performed environmental monitoring and clean room qualification before moving on to sterile finished product testing He then moved to a small startup company called SCM Pharma Here he set up a new microbiology lab and developed a new microbiology team He helped design and qualify the new clean rooms He then moved from microbiology to project management and became the technical manager

David then moved to Reckitt Benckiser at their Hull site where he discovered the magic and pain of working in an FMCG environment His role was to improve microbiological awareness on the site and a large amount of time was spent

investigating significant microbial contamination events with suppliers and products He was lucky enough to be sent across the world investigating microbiological issues on behalf of the company If you get caught by him at the bar he can bore you to death on the wonders of seaweed

In 2012 David moved back to GSK at the Ulverston site in the Lake District This is a large-scale primary API manufacturing site makes bulk sterile antibiotics It uses isolator technology in a primary environment which was a bit of a steep learning curveDavid started a new role as a microbiological consultant for Ecolab in March 2018 In this role David utilizes his experience to help Ecolabrsquos clients with microbiological and manufacturing issues across the globe

He is experienced in most drug dose forms from sterile needless injection systems explosive aseptic ampoules to inhalation devices oral doses of microbial sensitive products and sticky capsules Plus a great deal of primary manufacturing to boot He is now dipping his toe into the world of disinfectants and contamination control ndash a microbiologistrsquos best friend

Description Designed for those people who are new to industry this virtual training course will help you understand what sterile manufacturing is and will cover topics which include microbiology clean room design sterilisation processes sterility assurance manufacturing methods and regulatory oversight

Target audience (those new to industry) Microbiologists cleanroom operators production quality engineers and sales amp marketing

It is designed tobull Get you to think about the risks associated with sterile

manufacturingbull Understand the basic elements of sterility assurance

The course will supportbull Building greater people capability and consistency in your

sterile operations bull Reducing quality issues waste defects and accidentsbull Being better able to meet your regulators expectationsbull Releasing batches more consistently v get products to the

patient more reliablybull Better management of individual performance

At the end of this virtual training programme you willbull Have an underpinning awareness of sterile manufacturing

and associated risksbull Attain an introductory understanding and knowledge of

key sterile processes and controls

An Introduction to Sterile Manufacturing

Your Presenter David KeenDirector Pharmaceutical Microbiology amp Consulting - Ecolab amp Pharmig Chair

An Introduction to Sterile Manufacturing21ST AND 22ND APRIL 2021

Pharmig is a non-profit making professional organisation established in 1991 that represents the interests of individuals who work in have responsibility for or work alongside microbiology within pharmaceutical healthcare cosmetics amp NHS Industries It provides a focus for continuing professional development and serves as a

unique network for the exchange of microbiological information through training courses conferences publications and its website forum The Group has grown significantly since 1991 expanding the portfolio of products it now offers to the Membership whilst remaining true to the initial needs of microbiologists which include

bull Organising meetings training courses conferences and producing publications that provide topical information

and views on microbiologically related topics

bull Advancing the science of microbiology and its practical application

bull Influencing the development of regulations and guidelines surrounding microbiology

bull Acting as a confidential forum for the dissemination of information concerning all aspects of microbiology

About Pharmig wwwpharmigorguk

WEDNESDAY 21st April1300 ndash 1310 0800 ndash 0810 Welcome David Keen Director

Pharmaceutical Microbiology amp Consulting - Ecolab amp Pharmig Chair

1310 ndash 1355 0810 ndash 0855 Introduction to sterile manufacturing bull What does sterile mean bull Why do we need sterile products bull Sterile vs aseptic ndash are they the same

1355 ndash 1400 0855 ndash 0900 QampA session

1400 ndash 1445 0900 ndash 0945 Introduction to microbiology bull What is microbiology bull The bacteria moulds and yeasts virology

parasites and TSEs bull Controlling and understanding microbial

growth

1445 ndash 1500 0945 ndash 1000 QampA session and virtual break

1500 ndash 1545 1000 ndash 1045 Introduction to cleanrooms bull What is a cleanroom bull Cleanroom grades and controls bull Design and equipment bull Cleanrooms as a contamination control

system bull Cleanroom behaviours

1545 ndash 1600 1045 ndash 1100 QampA session and close of virtual

day one

THURSDAY 22nd April1300 ndash 1310 0800 ndash 0810 Welcome back

1310 ndash 1355 0810 ndash 0855 Methods of sterilisation bull Moist and dry heat bull Filtration bull Irradiation and e-beam bull Chemical

1355 ndash 1400 0855 ndash 0900 QampA session

1400 ndash 1445 0900 ndash 0945 Process manufacturing bull Common product dose forms bull How to manufacture these dose forms bull Isolators RABS and open filling bull Blow fill seal freeze drying bull Process simulations media fills and broth

trials

1445 ndash 1500 0945 ndash 1000 QampA session and virtual break

1500 ndash 1545 1000 ndash 1045 Sterility assurance bull What is sterility assurance

bull Risk based manufacturing

bull Determination of sterility

1545 ndash 1550 1045 ndash 1050 QampA session

1550 ndash 1630 1050 ndash 1130 Sterile manufacturing and the

regulations and compliance to GMP bull Why is there a need for regulations

bull Who regulates the pharmaceutical

industry

bull Are you inspection ready

1630 ndash 1645 1130 ndash 1145 QampA session and closing remarks of

virtual day two

An Introduction to Sterile Manufacturing (via Zoom)Programme outline running as 2 half-day virtual meetings

KEY RE TIMESBLUE ndash BST (British Summer Time)GREEN ndash EST (Eastern Standard Time)

Please note all information addressed by the speakers are of their own their company opinions and viewpoints Pharmig is not responsible for any content presented at the meeting

Pharmig also has the right to change the programme at any time due to unforeseen circumstances

An Introduction to Sterile Manufacturing21ST AND 22ND APRIL 2021

Company

Contact Name (if different from those attending)

Email

DELEGATE ONE

Name

Job Title

Email

Fee (poundeuro$)

Address

Tel

DELEGATE TWO

Name

Job Title

Email

Fee (poundeuro$)

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

BOOKING FORMAN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES 21ST amp 22ND APRIL 2021

FEES - VIRTUAL INTRODUCTION TO STERILE MANUFACTURING(which covers 2 half-day events on the 21st amp 22nd April)

PHARMIG MEMBER FEES Euro Dollar NON MEMBER FEES Euro Dollar Delegate pound200 euro245 $284 Delegate pound400 euro470 $560 Fee is higher to cover conversion rates Fee is higher to cover conversion rates

NHS PHARMIG MEMBER FEES NHS NON MEMBER FEES Delegate pound100 Delegate pound200

INFORMATION ON FEES amp PAYMENTS

bull The fees advertised cover 2 half-days on the 21st amp 22nd April 2021

bull Pharmig cannot reduce this fee if you can only attend one of the morning sessions

bull Fees must be paid in advance in order to attend the virtual conference This can be done via credit card payment OR by an approved company purchase order number

poundeuro$

poundeuro$

poundeuro$

For poundeuro$

Please raise an invoice to cover the delegate fee(s)

UK BACS Sort code 60 19 28 Account 80843867

Wire Transfer

Natwest Bank 118 High Street Slough Berkshire SL1 1JH

SWIFT (BIC) NWB KGB2L Account 80843867

IBAN GB64 NWBK 6019 2880 843 867

Please quote company approved purchase order no

We wish to pay by credit card (Pharmig will contact you for details)

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

Please note Due to these unusual times and the need for Pharmig to ensure fees are received in a timely manner before the event it will have the right to cancel a delegatersquos attendance unless alternative arrangements have been agreed in advance of the event(s) by both parties

PAYMENTAN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES 21ST amp 22ND APRIL 2021

INFORMATION ON ZOOM SET UPOnce you have sent back your registration form and payment (please see info of fees and payments above) Pharmig will add you to the

Zoom list and will send out an email which will include TWO SEPARATE ZOOM LINKS (one for each day) for you to click onto for the 21st

amp 22nd April

For those not familiar with Zoom ndash we will do a quick tour around the screen (itrsquos all very straightforward) before starting the session on the

afternoon of the 21st April

EMAIL OR FAX YOUR COMPLETED BOOKING FORM FOR A PROVISIONALCONFIRMED PLACE Email infopharmigorguk Fax to +44 (0) 1920 871 156

PRIVACY POLICY By registering for these events I accept the processing of my Personal Data Pharmig will use my data for the processing of this order for which I hereby declare to agree that my personal data is stored and processed Pharmig will only send information in relation to this order or similar eventspublicationstraining courses etc Pharmig may send your name and company only to other companies attending the same event in the form of an attendee list Your full personal data will not be disclosed to third parties (see also privacy policy at httpswwwpharmigorgukenprivacy-policy) You can ask for the modification correction or deletion of my data at any time via an email to maxinepharmigorguk

CANCELLATION POLICYWritten cancellation will be accepted up to 5 working days prior to the event and all cancellations will incur a fee No refunds are available 2 working days before the start date and full fees will be due for delegates who fail to attend Substitutions may be made at any time preferably in writing to Maxine Moorey Please email maxinepharmigorguk

Company

Contact Name (if different from those attending)

Email

DELEGATE ONE

Name

Job Title

Email

Fee (poundeuro$)

Address

Tel

DELEGATE TWO

Name

Job Title

Email

Fee (poundeuro$)

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

BOOKING FORMAN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES 21ST amp 22ND APRIL 2021

FEES - VIRTUAL INTRODUCTION TO STERILE MANUFACTURING(which covers 2 half-day events on the 21st amp 22nd April)

PHARMIG MEMBER FEES Euro Dollar NON MEMBER FEES Euro Dollar Delegate pound200 euro245 $284 Delegate pound400 euro470 $560 Fee is higher to cover conversion rates Fee is higher to cover conversion rates

NHS PHARMIG MEMBER FEES NHS NON MEMBER FEES Delegate pound100 Delegate pound200

INFORMATION ON FEES amp PAYMENTS

bull The fees advertised cover 2 half-days on the 21st amp 22nd April 2021

bull Pharmig cannot reduce this fee if you can only attend one of the morning sessions

bull Fees must be paid in advance in order to attend the virtual conference This can be done via credit card payment OR by an approved company purchase order number

poundeuro$

poundeuro$

poundeuro$

For poundeuro$

Please raise an invoice to cover the delegate fee(s)

UK BACS Sort code 60 19 28 Account 80843867

Wire Transfer

Natwest Bank 118 High Street Slough Berkshire SL1 1JH

SWIFT (BIC) NWB KGB2L Account 80843867

IBAN GB64 NWBK 6019 2880 843 867

Please quote company approved purchase order no

We wish to pay by credit card (Pharmig will contact you for details)

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

Please note Due to these unusual times and the need for Pharmig to ensure fees are received in a timely manner before the event it will have the right to cancel a delegatersquos attendance unless alternative arrangements have been agreed in advance of the event(s) by both parties

PAYMENTAN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES 21ST amp 22ND APRIL 2021

INFORMATION ON ZOOM SET UPOnce you have sent back your registration form and payment (please see info of fees and payments above) Pharmig will add you to the

Zoom list and will send out an email which will include TWO SEPARATE ZOOM LINKS (one for each day) for you to click onto for the 21st

amp 22nd April

For those not familiar with Zoom ndash we will do a quick tour around the screen (itrsquos all very straightforward) before starting the session on the

afternoon of the 21st April

EMAIL OR FAX YOUR COMPLETED BOOKING FORM FOR A PROVISIONALCONFIRMED PLACE Email infopharmigorguk Fax to +44 (0) 1920 871 156

PRIVACY POLICY By registering for these events I accept the processing of my Personal Data Pharmig will use my data for the processing of this order for which I hereby declare to agree that my personal data is stored and processed Pharmig will only send information in relation to this order or similar eventspublicationstraining courses etc Pharmig may send your name and company only to other companies attending the same event in the form of an attendee list Your full personal data will not be disclosed to third parties (see also privacy policy at httpswwwpharmigorgukenprivacy-policy) You can ask for the modification correction or deletion of my data at any time via an email to maxinepharmigorguk

CANCELLATION POLICYWritten cancellation will be accepted up to 5 working days prior to the event and all cancellations will incur a fee No refunds are available 2 working days before the start date and full fees will be due for delegates who fail to attend Substitutions may be made at any time preferably in writing to Maxine Moorey Please email maxinepharmigorguk

poundeuro$

poundeuro$

poundeuro$

For poundeuro$

Please raise an invoice to cover the delegate fee(s)

UK BACS Sort code 60 19 28 Account 80843867

Wire Transfer

Natwest Bank 118 High Street Slough Berkshire SL1 1JH

SWIFT (BIC) NWB KGB2L Account 80843867

IBAN GB64 NWBK 6019 2880 843 867

Please quote company approved purchase order no

We wish to pay by credit card (Pharmig will contact you for details)

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

Please note Due to these unusual times and the need for Pharmig to ensure fees are received in a timely manner before the event it will have the right to cancel a delegatersquos attendance unless alternative arrangements have been agreed in advance of the event(s) by both parties

PAYMENTAN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES 21ST amp 22ND APRIL 2021

INFORMATION ON ZOOM SET UPOnce you have sent back your registration form and payment (please see info of fees and payments above) Pharmig will add you to the

Zoom list and will send out an email which will include TWO SEPARATE ZOOM LINKS (one for each day) for you to click onto for the 21st

amp 22nd April

For those not familiar with Zoom ndash we will do a quick tour around the screen (itrsquos all very straightforward) before starting the session on the

afternoon of the 21st April

EMAIL OR FAX YOUR COMPLETED BOOKING FORM FOR A PROVISIONALCONFIRMED PLACE Email infopharmigorguk Fax to +44 (0) 1920 871 156

PRIVACY POLICY By registering for these events I accept the processing of my Personal Data Pharmig will use my data for the processing of this order for which I hereby declare to agree that my personal data is stored and processed Pharmig will only send information in relation to this order or similar eventspublicationstraining courses etc Pharmig may send your name and company only to other companies attending the same event in the form of an attendee list Your full personal data will not be disclosed to third parties (see also privacy policy at httpswwwpharmigorgukenprivacy-policy) You can ask for the modification correction or deletion of my data at any time via an email to maxinepharmigorguk

CANCELLATION POLICYWritten cancellation will be accepted up to 5 working days prior to the event and all cancellations will incur a fee No refunds are available 2 working days before the start date and full fees will be due for delegates who fail to attend Substitutions may be made at any time preferably in writing to Maxine Moorey Please email maxinepharmigorguk

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

Pharmig Publications

A series of 8 Major Objectionable Microorganisms Fact Sheets

One of the expectations of GMP regulators is that microbiology laboratories are knowledgeable about the main objectionable microorganisms that could be found in pharmaceutical products or in the manufacturing environmentThe identification characterisation and interpretation of these microorganisms can be challenging To act as a training aid and information resource Pharmig has produced eight new fact sheets (Fact Sheet Pack 2) Seven of the fact sheets profile some of the most important objectionable microorganisms (together with Geobacillus stearothermophilus used for biological indicators) An eighth fact sheet provides useful information about risk assessing objectionable microbes

Member pound30 Non Member pound50

This set of fact sheets features seven fungi which feature high in causes of fungal contamination of pharmaceutical products and which have led to several major pharmaceutical product recalls Each fact sheet presents information about the fungus including growth conditions and product patient risks Each sheet details a striking photograph of the fungus macroscopically growing on suitable agar and microscopically (as a methylene blue stain) The eighth fact sheet is a guide on the staining and microscopic examination of fungi includingkey features to note to help you with identification The fact sheets are laminated making them suitable for the laboratory bench and come enclosed within a presentation folder

Member pound30 Non Member pound50

A series of 8 Pharmaceutically Important Fungi Fact Sheets

Publication orders can be placed via the website - wwwpharmigorguk

bull Ensure your teams stay up-to-date on the crucial aspects of Cleaning and Disinfection of Cleanrooms by using our dynamic interactive online training portal which will make

bull Personnel training easy bull Convenient bull Quantifiable

bull The Pharmig Training Portal (TP) features high quality demonstration footage for the training of cleanroom operatives in the Pharmaceutical Healthcare Cosmetics and Medical Device Industries

bull Each training video is followed by detailed multiple choice questions about the subjects covered in the video modules

bull Each user is issued with a personalised certificate upon successful completion of the module

bull The Pharmig Training Portal features full administrator control enabling you to

bull Set the required pass mark bull Monitor and manage user activity

bull All of which results in better trained operatives working to best practice

InterestedThen please do visit the Pharmig website for more information and a video of the on-line Training Portal capabilities wwwpharmigorguk

If you would like a more detailed lsquovirtualrsquo demonstration led by a Pharmig Committee Member please do email Pharmig at infopharmigorguk and we will schedule in a time that suits you

PHARMIGrsquoS INTERACTIVE ON-LINE TRAINING MODULE ON CLEANING AND DISINFECTION OF CLEANROOMS

DONrsquoT LET COVID STOP YOUR VITAL STAFF TRAINING

Current perspectives on Environmental Monitoring - Review 1

This review surveys some of the current practices trends and approaches to environmental monitoring

Technical articles include

bull Constructing an environmental monitoring programme

bull Particle monitoring amp controlbull Environmental monitoring amp risk assessmentbull Microbiological risk assessment case study

Member pound60 Non Member pound85

Guide to Disinfectants amp their use in the Pharmaceutical Industry

The objective of this Guide is to review current standards to aid in the selection and validation of disinfectants

Key topics include

bull Types amp selection of disinfectantsbull Validation of disinfectants detailing

the BSEN current test methodsbull Practical use of disinfectants

Member pound60 Non Member pound85

A GUIDE TO

DISINFECTANTS amp THEIR USE IN THE PHARMACEUTICAL INDUSTRY

8791 Pharmig A Guide to Disinfectants and their Use in the Pharmaceutical Industryindd 1 24052017 1455

Best practices for the Bacterial Endotoxin Test A Guide to the LAL Assay

This guide to the Bacterial Endotoxin Test (BET) provides the reader with an overview of the history regulation and practical use of the different BET assays Information on method development validation and routine testing are discussed as well as more advanced subjects such as depyrogenation medical devices trouble shooting and problem samples The guide should provide a useful reference document for LAL users and laboratory management

Member pound50 Non Member pound75

Guide to Microbiology Laboratories in the Pharmaceutical Industry

This Guide details what Pharmig considers to be best practice for establishing and operating microbiology laboratories in pharma and associated industries

The Guide describes considerations to be applied to the design set up and running of the microbiology unit Topics range from

bull Test methods bull Environmental monitoring bull Documentation bull Method verification and validation

Member pound60 Non Member pound85

Pharmig Publications Publication orders can be placed via the website - wwwpharmigorguk

Water Microbiota ndash Pharmigrsquos latest series of 8 fact sheets

bull Ralstonia pickettiibull Stenotrophomonas maltophiliabull Burkholderia cepacia complexbull Acinetobacter baumanniibull Brevundimonas diminuta

bull Sphingomonas paucimobilisbull Pseudomonas aeruginosabull General overview of water

microorganisms

Member pound30 Non Member pound50

This series of 8 fact sheets will cover

LAL Fact Sheets

A series of Limulus Amoebocyte Lysate (LAL) laminated Fact Sheets on pyrogen endotoxin testing have been produced by the LAL Action GroupThe series of 6 LAL fact sheets (as a package)currently available are

bull What is LALBETbull Calculation of

Endotoxon Limitsbull Medical Devicesbull Gel Clot Methodsbull Photometric Methodsbull Product Validations

Quantitative Methods

Member pound20 Non Member pound35

Purchase

in conjunction

with Best practices for

the Bacterial Endotoxin

Test A Guide to the LAL

Assay and receive the

LAL Fact sheets

free of charge

The microbial enumeration test and test for specified microorganisms can represent a challenging area for pharmaceutical microbiology To act as a training aid for new staff and an aide memoire for more experienced staff - Pharmig has produced eight fact sheets Seven of the fact sheets profile each one of the key microorganisms (or microbial groups) using colour photographs illustrating growth on agar and by Gram-stain These are supported by facts relating to the organismrsquos profile and methods for identification The eighth sheet offers some useful guidance about the interpretation of the test

Member pound30 Non Member pound50

A series of 8 Microorganisms Fact Sheets

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

Guide to Cleanroom Operationand Contamination Control

Guide to Bacterial Identification

Pharmig PublicationsRapid amp Alternative Microbiological Methods

Rapid Microbiological Method technologies aim to provide more sensitive accurate precise and reproducible test results when compared with conventional growth-based methods They normally involve some form of automation and they often capture data electronically

Microbiologists can be inundated with literature advertising equipment and courses relating to lsquoRapid Microbiological Methodsrsquo and lsquoAlternative Microbiological Methodsrsquo

Often however the literature does not explain whether the method will work for the companyrsquos product range whether it is cost effective how it should be validated how any changes to microbiological risk are managed and if the purchase can be justified

Whilst costs cannot be discussed this document has been prepared

bull to describe the range of well developed established commercially available methods and their suitability for evaluating the microbiological quality of products or raw materials

bull to provide some guidance for microbiologists who are investigating the use of RAMM in routine quality control of cosmetics personal care products and pharmaceuticals

This publication is produced and sold as a PDF document only and is for the sole use of the individual purchasing it

Member pound20 Non Member pound35

Microbiological Control for Non-Sterile Pharmaceuticals

This publication is relevant to pharmaceuticalscosmetics amp toiletry industries and aims to provide guidance around GMP Topics include

bull Facility design and requirements bull Micro control bull Cleaning amp disinfectionbull Risk assessment amp managementbull Microbiological monitoring

Member pound60 Non Member pound85

Publication orders can be placed via the website - wwwpharmigorguk

This publication provides a short and informative introductory guide to cleanrooms Cleanrooms provide controlled critical environments for both sterile and non-sterile pharmaceutical manufacturing

The guide examines

bull Cleanroomsbull Different grades of cleanroomsbull The important aspects of physical controlbull Contamination control and environmental monitoringbull Important cleanroom parameters required by the

regulatory standards

Member pound60Non Member pound85

Microbial identification represents an important part of the microbiology function This includes screening products for objectionable organisms profiling the environmental microbiota and investigating out-of-limits events with a view to assigning a probable point of origin In deciding what and when (and subsequently to what level) to identify and by the way of which methods requires an identification strategy This is a document each microbiology laboratory should develop

During a Pharmig presentation on microbial identification strategy and a QampA session that followed there was a variation in approach and sometimes a lack of clarity concerning good identification practices and in outlining a strategy of what to identify and when To provide guidance for members and other microbiologists in the way of a training aid and to provide the basis for microbiology laboratories to benchmark against this guide was put together

The foreword has kindly been written by Andrew Hopkins ndash MHRA

Chapters within the Guide include

bull Cleanroomsbull Different grades of cleanroomsbull The important aspects of physical controlbull Contamination control and environmental monitoringbull Important cleanroom parameters required by the

regulatory standards

Member pound60Non Member pound85

GUIDE TO CLEANROOM OPERATION AND CONTAMINATION CONTROL

Best Practices in Microbiological Documentation - Electronic Pack One

This CD provides an overview of the most efficient practices in maintenance of the QC aspect of the microbiology laboratory and its associated documentation with reference to current regulatory expectations

Topics range from

bull General documentationbull Equipment documentationbull Laboratory test documentationbull Electronic documentation management systemsbull Non conformance documentationbull Example documents are also included

to assist companies in improving their documentation practices

Member pound75 Non Member pound99

Setting up amp Managing an Effective Training Programme in the Micro Laboratory ndash Electronic Pack Two

This training pack aims to help you gain a clear understanding of the structure of a regulatory acceptable and compliant training programme and includes example documents to assist companies in improving aiding their current training programmes

Topics range from

bull Employee development amp appraisalbull GMP introductionbull Training in microbiological

techniques amp non conformancesbull Train the trainer bull Training matrix

Member pound75 Non Member pound99

VIRTUAL MEETING ENGINEERING PRINCIPLES FOR MICROBIOLOGISTS amp NON-ENGINEERS A BRIEF lsquoVIRTUALrsquo SNAPSHOT Wednesday 31st March 2021

CURRENT WEBINARS

A cost and time-effective frac12 day virtual meeting for non-engineers to

gain a quick snapshot into understanding key engineering principles

used in the life-sciences It will help enable individuals to converse

effectively with suppliers and engineers and contribute to operational

teams during projects deviation investigations risk assessments and

operational improvements

Please click here to view the full agenda

Who should attendbull Anyone who has responsibility for or contributed to production

environment measures modification and controls (eg QPrsquos QA

personnel microbiologist R amp D specialist production technician)

bull People working in operations technical and quality functions as well

as microbiologists

Pharmig An additional meeting and a series of webinars currently available

Handling data integrity concerns in the microbiology laboratory

Risks and control strategies for Burkholderia cepacian complex

Help I have bacterial spore contamination amp I donrsquot know what to do about it

EN17141 - What to make of the new Biocontamination Control Standard

Wednesday 24th March 2pm (BST) 9am (EST)

Led by Dr Tim Sandle

Data integrity for microbiology includes different aspects which need drawing out (such as specific equipment and culture media) This webinar considersbull What is data integritybull Regulationsbull Data and ALOCA+bull Variability of microbial databull Examples of DI and microbiological databull Rapid microbiology methodsbull Best practice examplesbull Risk assessment

Click here for more information

Wednesday 14th April 2pm (BST) 9am (EST) Led by Dr Tim Sandle

The major organism of concern for non-sterile microbiology is Burkholderia cepacian presenting a risk to inhalers and water systems This webinar considersbull What is the Burkholderia cepacia complexbull Why is BCC a concernbull Where is it found in pharmaceuticals and healthcarebull Patient risk factorsbull Regulatory viewsbull Test methodbull Identification

Click here for more information

Thursday 21st October 2pm (BST) 9am (EST) Led by Dr Tim Sandle

Bacterial spores are difficult to eliminate from cleanrooms and present challenges for cleaning and disinfection regimes This webinar considersbull Overview of sporesbull Bacterialbull Fungalbull This is an important distinctionbull Risks posed by sporesbull Issue of disinfectant sporicide resistance

Click here for more information

Thursday July 8th 2pm (BST) 9am (EST) Led by Dr Tim Sandle

In 2020 a new contamination control standard has been issued specifically focusing on biocontamination control titled EN 17141 2020 ldquoCleanrooms and associated controlled environments mdash Biocontamination controlrdquo Does this standard address the needs of the industry This does not seem to be the case While the standard covers a number of important areas there are stand-out gaps and some inaccuracies to be addressed Tim Sandle looks at these in the context of what is needed for a robust biocontamination control programIn this presentation Tim Sandle will look atbull What is the EN 171412020 standard Where did come from and what does it coverbull What is biocontamination and controlbull The standardrsquos risk-based approach to contamination

bull Considerations in developing a contamination control programbull Sample locations and sample frequenciesbull Methods and their applicationbull Limit setting trending and data distributionbull Microbiotabull Overall assessment of the standard and the gaps to be filled

Click here for more information

For more information contactT + 44 (0) 1920 871 999 F +44 (0) 1920 871 156E infopharmigorguk W wwwpharmigorguk

FEES FOR EACH WEBINARPharmig Members pound70 $110 (per person attending) Non Members pound100 $150 (per person attending)

Pharmig

T5 The Maltings

Roydon Road

Stanstead Abbotts

Hertfordshire

SG12 8HG

United Kingdom

Tel +44 (0) 1920 871 999 Fax +44 (0) 1920 871 156

Email infopharmigorguk Web wwwpharmigorguk

pharmig_group

Pharmig (Excellence in Microbiology)

PharmaMicro

Pharmig Microbiology

Pharmig (Excellence in Microbiology)

PLEASE DO FOLLOW US ONhellip