Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: John R. Godshalk

OVERVIEW:
This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.

The webinar explores what the GxP regulations and guidance’s say about Good Documentation Practice. Examples of both good and poor documentation are given and exercises demonstrate both good and poor practices.

Why should you Attend: In today’s strict regulatory environment it is more important than ever for companies and individuals to understand and practice good documentation to comply with FDA regulatory requirements. This webinar will cover Good Documentation Practice for GxP environments. Understand what needs to be documented, what FDA looks for in documentation, relevant regulations for documentation, and related guidance’s.

Areas Covered in the Session:
– FDA 101: who is the FDA, regulations, guidance’s, documentation and industry
– Why document?
– What needs to be documented?
– What documentation does FDA look for during an inspection?
– What do the GMP, GCP, and GLP regulations and guidance’s say about documentation?
– Examples and exercises for good documentation
– Summary/ Q&A

Who Will Benefit:
– GxP personnel involved with GxP Documentation
– R&D
– Production
– Quality
– Regulatory

SPEAKER PROFILE:
John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy. He has audited/inspected hundreds of pharma and biotech companies and reviewed processes and PV at these plants. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University.