Batch Record Review and Investigation Workshop
A One-Day COMPREHENSIVE & INTERACTIVE COURSE & WORKSHOP
Receive a Credit toward the Diploma program in Pharmaceutical Quality Assurance
Live interactive and instructor led
Course Outline
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
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
- Product Development
- Others who interact together to launch a product
Certificate of Attendance and Course Material
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.
