This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
Why Should You Attend:
In today's strict regulatory environment it is more important than ever for companies and individuals to understand and apply good data integrity practice to comply with FDA regulatory requirements and the new draft guidance.
This session will be presented by R. Godshalk, who served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). Prior to joining FDA he worked as research engineer for 10 years.
Learning Objectives
- Understand what data integrity is
- Know the relevant regulations for data integrity
- Understand why to record data and create records
- Understand the basics for software and data integrity
- Know what documentation/evidence does FDA look for during an inspection with regard to data integrity
- Review the recent draft guidance on data integrity
- Understand examples of Data Integrity issues: data integrity and the pre-approval inspection, data integrity in the lab, data integrity in the batch record, computer systems, data falsification, importance of audits
Areas Covered
- What is data integrity?
- What are the relevant regulations for data integrity?
- Why record data and create records?
- What is the interaction with software and data integrity?
- What documentation/evidence does FDA look for during an inspection with regard to data integrity?
- Examples of Data Integrity issues: data integrity and the pre-approval inspection, data integrity in the lab, data integrity in the batch record, computer systems, data falsification, importance of audits
- Summary/ Q&A
Instructor
John R. Godshalk, B.S., MBA, is a Senior Consultant with the Biologics Consulting Group, Inc.
During his tenure at DMPQ, John gained experience with products that include drugs, drug/device combination products, viral and bacterial vaccines, recombinant therapeutic and fractionation products, in vitro diagnostic test kits, and 510K medical devices.
His inspection experience includes leading inspections of active pharmaceutical ingredient manufacturers, aseptic filling and finishing facilities, and contract manufacturers. He has performed numerous pre-approval and pre-licensing inspections for biological and biotechnology products.
In addition, he has evaluated industry responses both for technical and regulatory merit during FDA regulatory compliance actions, and has assessed these responses and offered alternative solutions to resolve technical issues and regulatory concerns.
John has developed and given training programs for the FDA and regulated industry on pharmaceutical water, processing and instrumentation, lyophilization, cleaning methods and validation, and facilities for cell and gene therapy. He contributed to formulation of FDA policy as a member of the committee writing the Guidance Document for the Facilities and Controls for Cellular and Gene Therapy Product Manufacturing Operations.
John has served as chair in the review of the Chemistry Manufacturing and Controls (CMC) sections of Biologics License Applications and Supplements for both novel and licensed biological products at CBER. He has trained CBER staff on the scientific and regulatory review and evaluation of these applications and supplements.
Prior to joining FDA, John was a research engineer in industrial biotech. He also used his business experience and MBA as a consultant in the areas of business planning, marketing, information technology and strategic planning, financial modeling and analysis, budgeting, business process engineering, project management, and management consulting.