Conducting Effective Annual Product Review
One & A Half-Day COMPREHENSIVE & INTERACTIVE COURSE, CASE STUDIES & WORKSHOP
Receive a Credit toward the Diploma program in Quality Assurance and Regulatory Affairs
Distinguished Faculty
Dr. Mary Mazur-Melnyk
Chief Scientific Officer
Innovalinks
Dr. Mary Mazur-Melnyk was educated in Toronto and holds a M.Sc. in Medical Sciences and a Ph.D. in Molecular Biology. She brings to the table over 20 years of experience in Biologics, Medical Devices and Biopharmaceutical industries. She has held senior level position in the areas of Regulatory Affairs and Quality Assurance at Aventis Pasteur, GSK, Novartis and most recently for Biovail Corporation as their Corporate Vice President of Quality. Currently, she is a Senior Partner with Innovalinks Quality Consultants (IQC), which specializes in the areas of Regulatory and Quality systems. She has extensive experience in the areas of technology transfer, R and D streamlining, and global regulatory approvals of NCEs.
Registration Fee Includes
Presentation Materials, Luncheon, Refreshment and Free Parking
Note: Please indicate any special Dietary requirements when registering for the course
Dates Available
March 26-27, 2012
Time
9:00 a.m. – 5:00 p.m.
Cost
CAD $895.00 + HST
Location
AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277
Abstract
Annual Product Review (APR) is a critical cGMP requirement. It is an integral part of QA function, which provides an opportunity to assess the state-of-control of the product and process. Annual Product Reviews not only are required by GMP but also can be a robust quality improvement tool if utilized properly. This workshop examines FDA requirements and provides insight into inspectors' expectations. This one and a half day interactive course and workshop provides participants with essential tools for developing and implementing an effective and efficient Annual Product Review program. Topics include SOPs; statistical analysis of APR, how to streamline your APR process; documentation; revalidation and change control; EU requirements for Product Quality Reviews; and more. Participants learn industry best practices and return to their jobs prepared to both conduct and write APRs
Course Outline
- Introduction to Annual Product Review
- Why are APRs required
- GMP requirements for Annual Product Reviews
- Regulatory requirements stated in 21 CFR 211.180(e)
- APR’s relationship to other quality system components
- Key benefits or purposes for effective APRs
- Assess needed changes in product specifications
- Assess needed changes in manufacturing or control procedures
- Determine if validation or revalidation is needed
- Identify product improvement or cost reduction opportunities
- Confirm change control systems
- Provide a preparation tool for FDA inspections
- Communicate product and process status to management
- Typical contents of an Annual Product Review
- Preparation of APR SOP
- APR schedule
- In-process, finished product and stability results
- Deviations/Investigations/rework
- Review of returned or salvaged products
- Review of complaints and recalls
- Conclusions
- Interpretation of APR results
- Records and data
- Batch record review
- What documents and data should be reviewed
- Validation data
- Document resulting actions and outcomes
- Examine complaints, recalls, returned or salvaged drug products
- Investigations data
- Corrective actions
- Statistical analysis of APR data
- Define statistical terms and concepts
- Trending
- Examine statistical techniques relevant to APRs
- Interpret statistical data to identify trends and deviations
- Approaches for completing APRs
- APR owner, APR administrator, APR team
- Management commitment
- Decision making based on APRs
- Analysis of data forms basis for changes to processes and/or specifications
- Obtain regulatory approval for change if necessary
- Change control process guides implementation
- Ensure completion of change through appropriate audit(s)
- Regulatory expectations for Annual Product Reviews
- Follow up on actions
- Routine assignment of corrective or improvement actions
- QA review and approval of the APRs
- Management involvement in the APR process
- Review warning letters citing APR violations
Who Should Attend
This two-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.
