Batch Record Review and Investigation Workshop

Batch Record Review and Investigation Workshop Course Outline I. Regulatory Requirements for GMP    Documents Analyze GMP requirements for batch records Types of Regulated documents and relative importance Development of a Master Batch Record II. Basic Requirements and Techniques for Batch Record Review Review process and SOP Roles and responsibilities Effective review practices and tools to identify discrepancies Application skills for preventative actions III. Techniques for Performing a Technical Review and Conducting Follow-Up Investigations Review of Analytical Data Ensure correct reconciliation (product, label) Investigation processes (Out-of Specification test results and deviations) Production process consistency Product disposition evaluation IV. Workshop – Review of a Mock Batch Production Record V. Documentation GMP and Regulatory Trends Who Should Attend This one day course is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas: Regulatory Affairs Quality Assurance Product Submission Training Consultants Clinical Research Documentation and Technical Writing Project Management Date: September 13, 2019     Time: 9:00 a.m. - 5:00 p.m.     Registration Fee: CAD $585.00 + HST Location: AAPS Training Center 200 Consumers Road,  Suite 200 North York,  Ontario M2J 4R4 Canada Telephone: 416-502-2277 For more information please visit: www.aaps.ca Please click the link below to register. See what's happening on our social sites: ‌ ‌ ‌ ‌ Copyright ® 2019 Academy of Applied Pharmaceutical Sciences (AAPS) Inc.

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