25-26 August, 2015, Holiday Inn, Mumbai

27-28 August, 2015, Novotel, Ahmedabad

Best practices for handling

unannounced audits.

Christopher Smith,
Former US FDA

Chinmoy Roy,
FDA Consultant

Introduction
Indian pharmaceutical companies are on the radar of FDAs observations. The pace
of ever-evolving standards have led to decry of this industry. Spate of import alerts,
export bans and warning letters (Form 483) over the last two years have
unexpectedly increased. And these were issued mainly during surprise audits
conducted by the global regulatory authorities. Indian Pharma accounts for the
highest number warning letters issued by the USFDA at the same time it also
accounts for nearly 40% imports by the US market. At this juncture it is extremely
important to bring synchronization amongst the two. Keeping this in mind CPhI India
brings you a two day workshop on unannounced audits.
The event is scheduled on 25-26 August in Mumbai and 27-28 August in
Ahmedabad. This two day workshop will provide you insights on strategies to handle
unannounced audits and be prepared for it at any point of time. The Workshop is
focused on addressing challenges faced by pharma professionals before and during
a pharma audit.

Workshop Leaders/Expert Trainers

Christopher Smith, Former US FDA
Christopher Smith is the Founder and President of Coastal Pharmaceutical Consultants,
Inc., an independent consulting company. He has more than 30 years of experience
in the pharmaceutical industry having held senior positions at the FDA, large and
small pharmaceutical companies and clinical and CMC focused contract
research organizations.
Prior to founding Coastal Pharmaceutical Consultants, Mr. Smith was Vice President,
Regulatory Affairs and Quality Assurance at AAIPharma Services Corp., a provider of
contract research and development services to the pharmaceutical, biotech and medical
device industries including regulatory and quality consulting services. Mr. Smith returned to AAIPharma
following the successful establishment and sale of Endeavor Pharmaceuticals, a start up virtual
company focused on the development of therapies for womens health at which he was Vice President,
Regulatory Affairs and Quality Assurance and a member of the Executive Committee. Mr. Smith joined
Endeavor after nine years at AAIPharma where he served on the Executive Committee and held the
position of Global Vice President, Regulatory Affairs and Quality Assurance. He was one of the key
authors of FDAs last major rewrite of the IND and NDA regulations in the 1980s and managed several
other key FDA regulatory initiatives such as the tamper-resistant packaging regulations following the
cyanide poisonings with Tylenol in 1982

Chinmoy Roy, FDA Consultant

Chinmoy Roy is a seasoned Life Sciences Engineer. Considered an implementation expert, he offers
over 35 years of US based subject matter expertise in QA, CSV, Data Integrity, Quality Risk
management, CFR 21 Part 11/Annex 11 compliance of manufacturing automation and IT
systems. He has used his field expertise to successfully defend many regulatory
agency audits, authored several QA Governance documents, facilitated Quality Risk
Assessments and provided input to development of industry standards. He was
one of the pioneers for 21 CFR Part 11 implementation and his teams
implementation efforts were a precursor to FDAs Part 11 Scope and Application
Guidance document in 2003. Currently, he is consulting with a major Indian
pharmaceutical company to establish their Data Integrity infrastructure as part of their
Data Integrity remediation program.

Agenda
DAY 1
08:30 - 09:00

Registrations and Networking

09:00 - 09:30

Opening Remarks

09:30 - 10:20

Understanding FDA: Laws, Regulations, Mission, Organization

Christopher Smith, Former FDA

10:20 - 10:50

Morning refreshments

10:50 - 13:00

Navigating and Surviving an FDA Inspection

Christopher Smith, Former FDA

13:00 - 14:00

Lunch & Networking

14:00 - 15:30

Data Integrity: A Key Focus in Today's FDA Audits

Chinmoy Roy, FDA Consultant

15:30 - 15:45

High Tea & Networking

15:45 - 17:30

Data Integrity Continued

Chinmoy Roy, FDA Consultant

DAY 2
09:30 - 10:30

A Look at 483s, Warning Letters and Consent Decrees

Christopher Smith, Former FDA

10:30 - 10:50

Morning refreshments

10:50 - 13:00

Quality Risk Management: Another Key Focus in

Today's FDA Audits
Chinmoy Roy, FDA Consultant

13:00 - 14:00

Lunch & Networking

14:00 - 15:30

Conducting Internal Audits

Chinmoy Roy, FDA Consultant

15:30 - 15:45

High Tea & Networking

15:45 - 16:30

GMPs and FDA Inspections: an Update on Current Initiatives

Christopher Smith, Former FDA

Head

Who should attend?

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