| Description |
Providing the step-by-step foundation for GMP and FDA compliance requirements for batch record reviews, this comprehensive training course concentrates on practical instructions for accelerating the review process. Specific techniques for conducting a batch record review include establishing written procedures and SOPs for the approval process, and ensuring compliance with up-to-date electronic signatures and documentation (CFR Part 11). Further details of ensuring quality and uniform character during Scale-up/Scale-down changes are also discussed. The training provides an understand- ing of regulatory requirements by reviewing deviations, investigations and OOS reports. Additionally, this course identifies batch-related inconsistencies and their potential causes through sample 483's to help avoid common deficiencies. After evaluating specific investigation findings, this course covers how to implement and conduct the necessary follow-up and prepare for product annual reviews. By the end of this two-day retreat, attendees will have acquired the skill sets to interpret GMP and FDA requirements, identify hidden compliance, analyze specific discrepancies, prepare investigation reports and ensure proper batch results.
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