Day 1 – Session

A session at 2-day In-person Seminar on “Why is FDA at my Facility, and What do I do During an Inspection” at Singapore

Thursday 6th February, 2014

9:00am to 6:00pm (SMT)

Lecture 1: How a firm should prepare for an FDA inspection
Lecture 2: Ways to train employees in view of the inspection
Lecture 3: How to ensure that required documentation is in place
Lecture 4: How to interact with the investigator-DO's and DON'T's
Lecture 5: What companies should do when the inspection ends
Lecture 6: How to reply to 483's and warning letters
Lecture 7: Legal implications of non-compliance
Lecture 8: Post inspection actions

About the speaker

This person is speaking at this event.
David R. Dills

Regulatory & Compliance Consultant

Speaker Profile:
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

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Time 9:00am6:00pm SMT

Date Thu 6th February 2014

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