Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing

1. SHAMISHA
MANAGEMENT CONSULTANTS

2. Pharma Consulting
Right Recruitment
Right Technical Training
Right Soft Skills Training
Shamisha Delivers
SHAMISHA

3. 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 Affairs
and Audits & Compliance for greenfield projects of
Multinational organizations like Jubilant Life Sciences,
OmniActives Health Technologies., USV, Zydus Cadila
Healthcare, 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, Searle
and P&G . Nina is M. Pharm. P. hd. From IIT, BHU.

4. 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
Kamna

5. Shamisha JourneyPharmaConsulting
PharmaConsulting
Recruitment
TechnicalTraining
BehaviouralTraining
PharmaConsulting
Recruitment
PharmaConsulting
Recruitment
TechnicalTraining
BehaviouralTraining
CustomisedSolutions
2013-14 2015 2016 2017

6. The Key of Shamisha’s
Recruitment Success
Uniquely successful specialised recruitment company.
Enjoyed an exceptional growth trajectory since its launch
and has now established offices in Ahmadabad and
Mumbai.
Consultant staff already approaching 30 and planned to be
100 by the end of 2017.
We believe there are two reasons for our outstanding
performance. These reasons benefits our clients and our
candidates equally:
Knowledge
People
•Knowledge
Great insights into Pharma corporate sector,
founder being an industry top veteran of Indian
and multinational companies.
Application of visualisation techniques to cover all
elements of managerial, soft skills and leadership
requirements to perform the job in client’s best
interest.
Recruitment consultants with pharmaceutical
and scientific background
Deployment of the state of art techniques.
Understanding of evolving needs and objectives of
clients, and the capabilities & aspirations of the
candidate.

7. 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 of
experience are ready to work for you, now.
We Are Hiring.... For You

8. Technical Training
Soft Skills Training

9. 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

11. 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 TransferQMS

12. Why Shamisha Learning Centre
• Get updated frequent revisions, expectations and interpretation of
regulators.
• Over occupancy of line managers to achieve competitive targets, does not
leave space to read, assimilate and implement the new requirement and
leading to non compliances.
• Shamisha expertise provides insight on the inter organization regulatory
understanding and development.
• Shamisha fills the gap of missing in house expertise.
• Refresh all regulations and compliance requirements quickly and
comprehensively with Shamisha’s help.

13. Integration of Quality Risk
Management into
Pharmaceutical Quality System
Quality Risk Management is now at the
cutting edge of the life sciences industry
internationally. ICH Q9 Guideline on
Quality Risk Management (QRM) was
incorporated in ICH Q10 GMP by the US
FDA, MHRA, PIC/S, WHO and the EMEA.
Pharmaceutical professionals should be
able to use risk management techniques
and tools based on ICHQ9 to manage
product quality, manufacturing processes,
validation and compliance within a risk
based Quality Management System.
Method validation recently got highest
attention from regulatory agencies and
industry task forces. For example, FDA and
EMA released guidelines on method
validation and transfer, and USP has
proposed new approaches chapters for
integrated validation, verification and
transfer of analytical procedures, for
equivalency testing and for statistical
evaluation.
FDA's expectation for Analyst
Qualification, Requalification and
Analytical Method validation
Nov.
2016
Dec.
2016

14. FDA's New Enforcement of
21 CFR Part 11 for Data
Integrity
There is no doubt that data integrity is the
current and future inspection focus of all
regulatory heath care agencies. More than
50% inspection reports such as 483's and
Warning Letters quote data integrity as
deviations from GxP regulations.
It is well known that Tech transfer and
commercialization of Pharmaceutical
dosage forms is most challenging aspect of
Pharmaceutical business., Often perceived
as role of R&D is in reality a complex set of
activities which need to be executed in
flawless manner with cross functional
participation and top management support
is essential element of successful outcome.
Quality Risk Management is now at the
cutting edge of the life sciences industry
internationally. ICH Q10 Guideline was
incorporated in GMP by the US FDA,
MHRA, PIC/S, WHO and the EMEA
Technology Transfer -
Structured Process
Dec.
2016
Jan
2017

15. GMP for Excipient: New regulations for Exporters in EU
The quality of excipients is critical to assure
the safety, quality and efficacy of medicines.
Excipients have a wide range of applications
and are essential components of the drug
product formulation. Characteristics that
excipients impart to formulated drug products
include cosmetic appearance, stability and
delivery of the active ingredient. Therefore,
applying appropriate Good Manufacturing
Practice (GMP) principles to excipients is
essential.
In contrast to finished dosage forms and Active
Pharmaceutical Ingredients (APIs), there are no
specific GMP regulations for excipients. In
addition, there are a large number of
applications of this diverse range of materials
which makes the development of excipient
GMP guidelines challenging. However, there is
a general expectation that excipients are
manufactured to recognised GMP principles.
Q2,
2017
Jan.
2017

16. Process Validation and Cleaning Validation - Current
Regulations and implementation
The Process Validation Guidelines (January
2011) and the EU Annex 15: Qualification
and Validation (October 2015) outline the
general principles and approaches the two
regulatory bodies consider appropriate
elements of process validation for the
manufacture of human and animal drugs
and biological products, including Active
Pharmaceutical Ingredients (APIs).
These guidance's align Process Validation
activities with a product lifecycle concept
and with existing FDA and EU guidance's,
including the FDA/International
Conference on Harmonization (ICH),
Guidance for Industry, Q8 (R2)
Pharmaceutical Development, Q9 Quality
Risk Management, and Q10
Pharmaceutical Quality System. The
lifecycle concept, new to these Guidance's,
link product and process development,
qualification of the commercial
manufacturing process, and maintenance
of the process in a state of control during
routine commercial production. ns. s.
Q1,
2017

17. More...Upcoming Shamisha Technical
Courses
QbD and Design
Space.
How to conduct Stability
studies to avoid
Warning letters.
Setting of
Specification,
Acceptance criteria
and role of AQL.

18. More...Upcoming Shamisha Technical
Courses
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

19. Soft Skills Development
Most managers don’t
spend much time
talking with their
employees about their
soft skills
development.

20. Effective
Communication
Great communication skills can make all
the difference in your personal and
professional life. Information is
power, and as the speed of business
accelerates, information must be
communicated to employees faster
than ever before. Constant change
and increasing turbulence in the
business environment necessitate
more and more communication.
Personal
Effectiveness
Great communication skills can make all the
difference in your personal and
professional life. Information is power,
and as the speed of business accelerates,
information must be communicated to
employees faster than ever before.
Constant change and increasing
turbulence in the business environment
necessitate more and more
communication.
Dec.
2016
Nov.
2016

21. Change Management
Change Management is to complete a
significant change in the way an
organization works with a specified
budget and within a specified time.
70% of change projects never live up
to their promise. Now the change
managers have become more astute
at managing the politics of multiple
stakeholders.
Today more than ever, companies and leaders
need a road map to help them boost
employee engagement levels. Businesses
confuse employee engagement with
employee satisfaction. Satisfied and
engaged employees are two very different
things. A recent global study conducted by
the Gallup organization found that only 13
percent of employees are engaged with
their work.
Motivation &
Engagement
Jan.
2017
Feb.
2017

22. Coaching SkillsCritical
Conversations Coaching is about taking the ideas behind
motivation and working with the
people of an organisation to develop a
synergy in which employees are excited
to work and inspired to better
themselves. The cornerstone to
coaching is motivation. Before coaching
can take place on an individual level,
however, a coaching culture must be in
place within an organisation to sustain
individual coaching in a productive
way.
Need for Critical Conversations and
messaging is a constant demand in
today’s workplace. Crucial conversations
is a hands on practical approach, which
allows the participants to develop skills
necessary to successfully engage in
difficult conversations. Having a fruitful
conversation when the stakes are high,
options vary and emotions are higher is
a challenge for many Managers
Q1,
2017

23. Goal Setting Skills
Learning to set the right goals will help
you tap into your intrinsic motivation
and allow you to uncover your hidden
potential.
Studies show that extrinsic motivators
such as money are less efficient than
intrinsic motivators like autonomy, self-
mastery, or finding purpose. Intrinsic
motivation yields better results and
provides a greater sense of fulfilment
than extrinsic motivation does
Influencing Skills
There is a universal need to learn
to "influence" others without the use
of "formal" authority. Without influence,
managers are ineffective. There is growing
recognition that this is a core leadership
competency for managers, across industries
Q2,
2017

24. Negotiation Skills
Managing Projects
Through People
Project management is more stressful. The
limitations in the budget and time will force
you and your team to work harder. People
who have poor people skills cannot become
effective project managers. Project
management requires cooperation from all
parts of the team. Any quarrels and
misunderstanding between team members
will lead to delays in reaching the goal.
Negotiations play a vital role in our
personal and professional lives. People
who learn to negotiate put themselves in a
very powerful situation. It takes humility,
understanding and being able to listen to
other people. Once you do, and you keep
their point of view in mind as well as your
own, you will find you are much more
likely to win the day goal.
Feb.
2017
Q2,
2017

25. More...Upcoming Shamisha
Behavioural Courses
Trusteeship in
Position of Authority
Art of Thinking.
Art of Learning

26. Structured Solutions From Shamisha
Technical Issue
Resolution
Pre-Inspection
Audit.
Regulatory
Compliance Solutions
Leader’s Coaching &
Mentoring
Customised Training
Intervention

27. RightTechnical Training
Right Soft Skills Training
Right Recruitment
Customised Solutions
Make Your Organisation Future Ready ...
Partner Shamisha

28. Shamisha Management Consultants
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Phone : +91 2717-401570
Mobile : +91 7574857595 / 9824443676
Ahmedabad 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