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
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.
Key
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?
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individuals to understand and apply good data integrity practice to comply with FDA regulatory requirements and the new draft guidance.This session will be presented by R. Godshalk, who served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and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.
Key
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- Review the recent draft guidance on data integrity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 in the Webinar:
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
Who Will Benefit:
The following professionals from FDA regulated industries will benefit from this training:- Compliance Officers/Manager
- Facility Manager
- Validation Specialists/Manager
- Regulatory Affairs Manager
- Design Team/Architects
- Quality Manager
- Documentation specialists
- Auditors
- Manufacturing Engineers
Speaker
John R GodshalkCourse Provider
John R Godshalk,
