Day 2 – 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

Friday 7th February, 2014

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

Lecture 1: Why inspections are conducted and by what statutory authority
Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
Lecture 3: What is subject to FDA purview and what's off-limits
Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success
Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with
Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key
Lecture 7: The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development

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 Fri 7th February 2014

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