Batch Record Review and Investigation
Details
I. Regulatory Requirements for GMP Documents
- Analyze GMP requirements for batch records
- Types of Regulated documents and relative importance
- Master Batch Record
- Raw Material Records
- Manufacturing Records
- Specifications
- Raw Data
- Investigations-Deviation and Out of Specifications
- Change Control (batch scale up/down)
- Development of a Master Batch Record
- Relationship between R and D, Validation and Production
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
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AAPS is the Canadian premier Life Sciences and Pharmaceutical training college. The school was established in 2003 to address the growing demands by healthcare manufacturers for better prepared and more practically trained applicants. In tailored response, AAPS was designed and made operational by a team of highly experienced industry experts with one mission in mind; to create professional skill development programs that would exceed industry-training standards".
Employing only leading industry professionals with decades of experience, AAPS is setting the standard for pharmaceutical, food and healthcare training and career advancement. These experts continually develop and update the diploma programs and certificate courses at AAPS to meet the rigorous demands of the industry. ...
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