Event Detail
The Batch Record Review Process and Investigation of Discrepancies: Compliance, Training and Management
February 12 - 26, 2010
- Live Webinar PQ CANADA
BenAstrum
3-Session Live Web Training: Session 1: Friday, February 12, 2010 Session 2: Friday, February 19, 2010 Session 3: Friday, February 26, 2010 (9:20 a.m. - 11:30 a.m. EST) (8:20 a.m. - 10:30 a.m. CST) (6:20 a.m. - 8:30 a.m. PST) Instructor: Kerry P. Potter Learning Benefits: * Recognize the batch record review expectations of the FDA * How to prepare for a technical review of batch records * Discover the essentials of batch record reviewer training * Acquire confidence in determining the final decision and/or recommendations * What to do when a batch fails to meet specifications (discrepancies) * Identify the basics of an appropriate investigation * Moving from root cause to corrective and preventive action(s) * Establish a working relationship between production and quality reviewers * How to measure the effectiveness of the review process