Conducting Batch Record Reviews and Investigations
Training Overview
Improve Your Ability to:
- Comply with FDA and GMP requirements for batch record reviews to maintain compliance
- Implement techniques for changes in batch size (scale-up/scale-down) to maintain quality
- Analyze compliance issues for product re-processing/re-work to avoid regulatory action
- Prepare the investigation report when a batch fails to meet specifications to meet regulatory requirements for documentation
- Analyze batch-related discrepancies to determine cause and corrective and preventive action(s)
- Transition smoothly to an electronic batch record system to support the paperless trend
- Effectively prepare for product annual reviews to determine what changes need to be implemented
- Determine whether to reject, release or resample a batch to ensure both product integrity and satisfy regulatory requirements
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-03-047-L04. Initial release: 07/2006.
Booking Options
Booking Options:
- Register online or Call Customer Service - Tel: (866) 647-0921 or email register@pti-international.com
- Group Discounts (3 or more people for this course) - Call Michael Roche at (646) 895-7408 or email mroche@pti-international.com
- Bring this Course to Your Facility (10 or more people or further customization) - Call (800) 303-8194 or email OnSiteSolutions@pti-international.com