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Batch Record Review & Investigation
A One Day COMPREHENSIVE & INTERACTIVE COURSE &
WORKSHOP
Dates Available: September 21, 2010, April 16, 2011
Cost: $675.00 +GST
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
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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