SHAMISHA MANAGEMENT CONSULTANTS

Pharma ConsultingRight Recruitment

Right Technical TrainingRight Soft Skills Training

Shamisha Delivers

SHAMISHA

About Us• Headed by Experienced Pharma Technocrat

• Focused on Pharma Talent Acquisition (Hiring) & Talent Upgrade (Training)

• 30+ strong professional team

• Offices at Ahmadabad & Mumbai

Dr. Nishodh Saxena is a seasoned leader with 30+years of experience in executing Quality, Regulatory Affairsand Audits & Compliance for greenfield projects ofMultinational organizations like Jubilant Life Sciences,OmniActives Health Technologies., USV, Zydus CadilaHealthcare, Intas Pharmaceuticals, Dr. Reddy's Lab.covering Pharma, Biotech, in R& D organisations.

Dr. Nina Sharma is an industry veteran with over

30+ years experience in top management roles in

Formulations R&D of world class organisations like Pfizer,Novartis, Johnson & Johnson, Teva, Ranbaxy, Lupin, Searleand P&G . Nina is M. Pharm. P. hd. From IIT, BHU.

Team Shamisha

Gauri Dhanshree

Manisha Virendera

TwinkleSushma

Sujith

Sidhi BPriya

RakheeAnuradha

Dr. Nina Sharma, Managing Director Dr. Nishodh Saxena, Technical Director

Nishangi Parth

Sidhi S

SHAMISHA MUMBAI TEAM

SHAMISHA AHMEDABAD TEAM

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2013-14 2015 2016 2017

The Key of Shamisha’s Recruitment Success

Uniquely successful specialised recruitment company.

Enjoyed an exceptional growth trajectory since its launchand has now established offices in Ahmadabad andMumbai.

Consultant staff already approaching 30 and planned to be100 by the end of 2017.

We believe there are two reasons for our outstandingperformance. These reasons benefits our clients and ourcandidates equally:

KnowledgePeople

•KnowledgeGreat insights into Pharma corporate sector,founder being an industry top veteran of Indianand multinational companies.

Application of visualisation techniques to cover allelements of managerial, soft skills and leadershiprequirements to perform the job in client’s bestinterest.

Recruitment consultants with pharmaceuticaland scientific backgroundDeployment of the state of art techniques.

Understanding of evolving needs and objectives ofclients, and the capabilities & aspirations of thecandidate.

Shamisha’s Consultants

We recruit the best. ... with passion to succeed.

Best in class training for Recruiters.

Highest standards of professionalism and integrity.Generous rewards and incentives for Recruiters.

Shamisha’s exceptional people and their depth ofexperience are ready to work for you, now.

We Are Hiring.... For You

Technical Training

Soft Skills Training

Contemporary knowledge on the subject in each of the courses offered.

Personalized attention to participants the batch size is restricted to a cohesive group of 20 learners only.

Re-fresher knowledge nuggets to course participants trough digital media.

Shamisha Learning Center Advantage

Quality Audits & Self inspections

Continuous Improvement At

Shamisha Learning Center

Quality review & Risk Analysis

GAP analysis, Regulatory guidelines

Data Integrity & Validation

Root-cause analysis on OOS investigations Incidents / Deviations

Market complaints & Customer feedback (internal & external)

Shamisha Technical Expertise

Technology Transfer QMS

Why Shamisha Learning Centre• Get updated frequent revisions, expectations and interpretation of

regulators.

• Over occupancy of line managers to achieve competitive targets, does notleave space to read, assimilate and implement the new requirement andleading to non compliances.

• Shamisha expertise provides insight on the inter organization regulatoryunderstanding and development.

• Shamisha fills the gap of missing in house expertise.

• Refresh all regulations and compliance requirements quickly andcomprehensively with Shamisha’s help.

Integration of Quality Risk Management into

Pharmaceutical Quality System

Quality Risk Management is now at thecutting edge of the life sciences industryinternationally. ICH Q9 Guideline onQuality Risk Management (QRM) wasincorporated in ICH Q10 GMP by the USFDA, MHRA, PIC/S, WHO and the EMEA.Pharmaceutical professionals should beable to use risk management techniquesand tools based on ICHQ9 to manageproduct quality, manufacturing processes,validation and compliance within a riskbased Quality Management System.

Method validation recently got highestattention from regulatory agencies andindustry task forces. For example, FDA andEMA released guidelines on methodvalidation and transfer, and USP hasproposed new approaches chapters forintegrated validation, verification andtransfer of analytical procedures, forequivalency testing and for statisticalevaluation.

FDA's expectation for Analyst Qualification, Requalification and

Analytical Method validation

Nov. 2016

Dec. 2016

FDA's New Enforcement of 21 CFR Part 11 for Data

Integrity

There is no doubt that data integrity is thecurrent and future inspection focus of allregulatory heath care agencies. More than50% inspection reports such as 483's andWarning Letters quote data integrity asdeviations from GxP regulations.

It is well known that Tech transfer andcommercialization of Pharmaceuticaldosage forms is most challenging aspect ofPharmaceutical business., Often perceivedas role of R&D is in reality a complex set ofactivities which need to be executed inflawless manner with cross functionalparticipation and top management supportis essential element of successful outcome.Quality Risk Management is now at thecutting edge of the life sciences industryinternationally. ICH Q10 Guideline wasincorporated in GMP by the US FDA,MHRA, PIC/S, WHO and the EMEA

Technology Transfer -Structured Process

Dec. 2016

Jan 2017

GMP for Excipient: New regulations for Exporters in EU

The quality of excipients is critical to assurethe safety, quality and efficacy of medicines.Excipients have a wide range of applicationsand are essential components of the drugproduct formulation. Characteristics thatexcipients impart to formulated drug productsinclude cosmetic appearance, stability anddelivery of the active ingredient. Therefore,applying appropriate Good ManufacturingPractice (GMP) principles to excipients isessential.

In contrast to finished dosage forms and ActivePharmaceutical Ingredients (APIs), there are nospecific GMP regulations for excipients. Inaddition, there are a large number ofapplications of this diverse range of materialswhich makes the development of excipientGMP guidelines challenging. However, there isa general expectation that excipients aremanufactured to recognised GMP principles.

Q2, 2017

Jan. 2017

Process Validation and Cleaning Validation - Current Regulations and implementation

The Process Validation Guidelines (January2011) and the EU Annex 15: Qualificationand Validation (October 2015) outline thegeneral principles and approaches the tworegulatory bodies consider appropriateelements of process validation for themanufacture of human and animal drugsand biological products, including ActivePharmaceutical Ingredients (APIs).

These guidance's align Process Validationactivities with a product lifecycle conceptand with existing FDA and EU guidance's,including the FDA/InternationalConference on Harmonization (ICH),Guidance for Industry, Q8 (R2)Pharmaceutical Development, Q9 QualityRisk Management, and Q10Pharmaceutical Quality System. Thelifecycle concept, new to these Guidance's,link product and process development,qualification of the commercialmanufacturing process, and maintenanceof the process in a state of control duringroutine commercial production. ns. s.

Q1, 2017

More...Upcoming Shamisha TechnicalCourses

QbD and Design Space.

How to conduct Stability studies to avoid Warning letters.

Setting of Specification,

Acceptance criteria and role of AQL.

More...Upcoming Shamisha TechnicalCourses

New CDSCO GMP guidelines for Manufacturers -

Understanding the consequences and benefits .

Design and Management of Microbiology lab in

Regulated environment. Computer System Validation

- Step by Step implementation

Good laboratory Practices for non-

clinical laboratory studies- compliance to

21 CFR part 58

Soft Skills DevelopmentMost managers don’t

spend much time talking with their

employees about their soft skills

development.

Effective Communication

Great communication skills can make allthe difference in your personal andprofessional life. Information ispower, and as the speed of businessaccelerates, information must becommunicated to employees fasterthan ever before. Constant changeand increasing turbulence in thebusiness environment necessitatemore and more communication.

Personal Effectiveness

Great communication skills can make all thedifference in your personal andprofessional life. Information is power,and as the speed of business accelerates,information must be communicated toemployees faster than ever before.Constant change and increasingturbulence in the business environmentnecessitate more and morecommunication.

Dec. 2016

Nov. 2016

Change ManagementChange Management is to complete a

significant change in the way anorganization works with a specifiedbudget and within a specified time.70% of change projects never live upto their promise. Now the changemanagers have become more astuteat managing the politics of multiplestakeholders.

Today more than ever, companies and leadersneed a road map to help them boostemployee engagement levels. Businessesconfuse employee engagement withemployee satisfaction. Satisfied andengaged employees are two very differentthings. A recent global study conducted bythe Gallup organization found that only 13percent of employees are engaged withtheir work.

Motivation & Engagement

Jan. 2017

Feb. 2017

Coaching SkillsCritical Conversations Coaching is about taking the ideas behind

motivation and working with thepeople of an organisation to develop asynergy in which employees are excitedto work and inspired to betterthemselves. The cornerstone tocoaching is motivation. Before coachingcan take place on an individual level,however, a coaching culture must be inplace within an organisation to sustainindividual coaching in a productiveway.

Need for Critical Conversations andmessaging is a constant demand intoday’s workplace. Crucial conversationsis a hands on practical approach, whichallows the participants to develop skillsnecessary to successfully engage indifficult conversations. Having a fruitfulconversation when the stakes are high,options vary and emotions are higher isa challenge for many Managers

Q1, 2017

Goal Setting SkillsLearning to set the right goals will helpyou tap into your intrinsic motivationand allow you to uncover your hiddenpotential.Studies show that extrinsic motivatorssuch as money are less efficient thanintrinsic motivators like autonomy, self-mastery, or finding purpose. Intrinsicmotivation yields better results andprovides a greater sense of fulfilmentthan extrinsic motivation does

Influencing SkillsThere is a universal need to learnto "influence" others without the useof "formal" authority. Without influence,managers are ineffective. There is growingrecognition that this is a core leadershipcompetency for managers, across industries

Q2, 2017

Negotiation Skills

Managing Projects Through People

Project management is more stressful. Thelimitations in the budget and time will forceyou and your team to work harder. Peoplewho have poor people skills cannot becomeeffective project managers. Projectmanagement requires cooperation from allparts of the team. Any quarrels andmisunderstanding between team memberswill lead to delays in reaching the goal.

Negotiations play a vital role in ourpersonal and professional lives. Peoplewho learn to negotiate put themselves in avery powerful situation. It takes humility,understanding and being able to listen toother people. Once you do, and you keeptheir point of view in mind as well as yourown, you will find you are much morelikely to win the day goal.

Feb. 2017

Q2, 2017

More...Upcoming ShamishaBehavioural Courses

Trusteeship in

Position of Authority

Art of Thinking.Art of Learning

Structured Solutions From Shamisha

Technical Issue Resolution

Pre-Inspection

Audit.

Regulatory Compliance Solutions

Leader’s Coaching &Mentoring

Customised Training

Intervention

RightTechnical TrainingRight Soft Skills Training

Right RecruitmentCustomised Solutions

Make Your Organisation Future Ready ... Partner Shamisha

Shamisha Management Consultants-----------------------------------------------Phone : +91 2717-401570Mobile : +91 7574857595 / 9824443676Ahmedabad Office : B-330-331-332, Sobo Center,

Nr. Suncity South Bopal, Ahmedabad.(Gujarat)Mumbai Office : 218 Marathon Max Bldg, Hedgewar Chowk, LBS Road,

Mulund, Mumbai – 400080