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Batch Record Review & Investigation
A One Day COMPREHENSIVE & INTERACTIVE COURSE &
WORKSHOP
Dates Available: April 20, 2011
Cost: $675.00 +HST
Location: 200 Consumers
Road, Suite 200, Toronto, Ontario
Receive a Credit toward the Diploma program in Quality
Assurance
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 responsibilites
- 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
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.
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.
COURSE LOCATION
AAPS Training Center
200 Consumers Road, Suite 200 , Toronto , Ontario ,
M2J 4R4
tel: 416-502-2277
www.aaps.ca
Course schedule: 9am-5pm
*Registration Fee Includes:
Presentation Materials, Luncheon, Refreshment
and Free Parking
*Please indicate any special Dietary requirements
when registering for the course
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