FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials


Peggy J. Berry, MBA, RAC, is Keynote Speaker at ComplianceKey.She is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs departmen........

Overview

This webinar will review the current regulations, guidance documents for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling,and documentation requirements will also be reviewed and explored.

Why should you attend this webinar?

Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for your GMP documentation .

Areas Covered in the Session:

Who can Benefit:

Target Job Title : Directors, Managers, Supervisors in Regulatory Affairs, Manufacturing, Quality Assurance, and Clinical Operations
Target Industry : Small to midsized businesses (30- 400 employees)



Webinar Id: LSHCFP001

Training Options:

Duration: 90min mins

 Stop, pause, and rewind: learn at your own place.

Ratings:
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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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