Conducting Batch Record Reviews and Investigations
Course Description
Conducting batch record reviews properly and thoroughly is imperative to avoid getting into trouble with FDA. This comprehensive training course begins by reviewing regulations and guidance documents relevant to batch record reviews. Learn how to maintain quality during scale-up/scale-down changes, plan and execute batch record reviews and satisfy GMP requirements for APIs and excipients. Acquire proven writing skills to develop effective Standard Operating Procedures (SOPs). Gain strategies to transition smoothly to an electronic batch record system. The course also addresses how to evaluate investigation findings, respond to batch deviations, prepare an investigation report and more. Throughout the duration of the course, you will have the opportunity to interact with an expert instructor as well as your peers. By the end of this two-day course, you will have the skills and knowledge necessary to comply with FDA requirements and expectations for batch record reviews.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 your Course Guidance Manager at (646) 895-7447 or email CourseManager@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