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DTSTART;TZID=UTC:20200306T090000
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SUMMARY:Batch Record Review and Investigation Workshop
DESCRIPTION:Batch Record Review and Investigation Workshop	\n	A One-Day COMPREHENSIVE & INTERACTIVE COURSE & WORKSHOP\nReceive a Credit toward the Diploma program in Pharmaceutical Quality Assurance\n\n\n\nLive interactive and instructor led\n\nCourse Outline\nI. Regulatory Requirements for GMP Documents \n\nAnalyze GMP requirements for batch records\nTypes of Regulated documents and relative importance\n\nMaster Batch Record\nRaw Material Records\nManufacturing Records\nSpecifications\nRaw Data\nInvestigations-Deviation and Out of Specifications\nChange Control (batch scale up/down)\n\n\nDevelopment of a Master Batch Record\n\nRelationship between R and D\, Validation and Production\n\n\n\nII. Basic Requirements and Techniques for Batch Record Review \n\nReview process and SOP\nRoles and responsibilities\nEffective review practices and tools to identify discrepancies\nApplication skills for preventative actions\n\nIII. Techniques for Performing a Technical Review and Conducting Follow-Up Investigations \n\nReview of Analytical Data\nEnsure correct reconciliation (product\, label)\nInvestigation processes (Out-of Specification test results and deviations)\nProduction process consistency\nProduct disposition evaluation\n\nIV. Workshop – Review of a Mock Batch Production Record \nV. Documentation GMP and Regulatory Trends \nWho Should Attend\nThis 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: \n\nRegulatory Affairs\nQuality Assurance\nProduct Submission\nTraining\nConsultants\nClinical Research\nDocumentation and Technical Writing\nProject Management\nProduct Development\nOthers who interact together to launch a product\n\nCertificate of Attendance and Course Material\n\nAll participants will receive a certificate of attendance upon completion of the course.\nThe participants will be receiving specially prepared course manual.
URL:https://aapswebsite.schools.consulting/event/batch-record-review-and-investigation-workshop
LOCATION:AAPS Training Center\, 200 Consumers Road\, Suite 200\, Toronto\, Ontario\, M2J 4R4\, Canada
CATEGORIES:Onsite Training
ATTACH;FMTTYPE=image/jpeg:https://aapswebsite.schools.consulting/wp-content/uploads/1920x560-Desktop-workshops.jpg
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