Effective Cleaning Validation Practices for Pharmaceutical and Biopharmaceutical Manufacturers

Venue: Effective Cleaning Validation Practices

Location: Mississauga, Toronto, Canada

Event Date/Time: Mar 21, 2005 End Date/Time: Mar 22, 2005
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- Regulatory Aspects of Cleaning Validation Across Pharmaceutical, Biotech and Biological Manufacturing
- Validation Principles and Critical elements of cleaning validation
- Development of cleaning programs
- Preparing cleaning validation SOPs and protocols
- Selection of appropriate cleaning agents
- Sampling Methods, Planning, and Testing
- Residue detection
- Residue analysis - microbiological issues
- Selection of Most Suitable Analytical Method/s
- Product and equipment grouping strategies
- MACO and NOEL Calculations
- Dealing with unexpected results
- Review of FDA 483s on Cleaning Validation

- Preparing Cleaning Validation SOP
- Establishing Residue Limits and Acceptance Criteria
- Execution and results interpretation
- Determination of proper swab technique
- Designing a successful Cleaning Validation Master Plan
- Cleaning validation strategies and risk-based approaches

Dear Friends and Colleagues:
Once again in pursuit of excellence, the International Pharmaceutical Academy (IPA) is proud to bring you the 4th Pharmaceutical Cleaning Validation event, ā€¯Effective Cleaning Validation Practices for Pharmaceutical and Biopharmaceutical Manufacturers".

Development of cleaning programs is a rigorous, time consuming, labor intensive and often frustrating experience. The objective of cleaning validation is to ensure that a specific cleaning process will consistently clean to predetermined limits so as to prevent contaminants from leaving residues that will adulterate and adversely affect the safety and quality of the next product manufactured. Cleaning validation is documented proof that one can consistently and effectively cleanse a system or equipment item.

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. FDA's risk-based regulatory initiatives focus new attention on the risks of cross-contamination. The solution is to understand life cycle management techniques for an effective cleaning validation program.

The objective of this year's program is to present specific information on how to achieve efficiencies in establishing a compliant Cleaning Validation program and related new regulatory processes, and to provide a solid overview of the principles and technology of residue removal and residue measurement on product contact surfaces.
As an institute for providing quality training and skills development programs, IPA is proud to bring together expert presenters from across the borders to share their experiences and in-depth knowledge and address latest issues, industry practices and compliance strategies regarding cleaning techniques, cleaning agents, sampling techniques, analytical methods, establishing residue limits, grouping strategies and validation SOPs and protocols.

Participants are encouraged to bring their cleaning problems to the course for group discussion.

Who Should Attend:
Because of its comprehensive content, this course will be most valuable to Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Vitamin, Herbal, and allied industries with daily responsibilities in the following areas:

- Cleaning validation programs, including development, deployment, and maintenance
- Quality Control
- Analytical R&D
- Validation Services
- Manufacturing
- Technical Support
- Quality Assurance
- GMP/GLP Compliance
- Regulatory Affairs
- Toxicologists
- Product Submission
- Training
- Documentation and Technical Writing
- Engineering
- Contract Laboratories
- Consultants
- Contract manufacturing
- Individuals who need to understand the science of cleaning and cleaning validation


Hilton Toronto Airport, 5875 Airport Road, Mississauga, Ontario, Canada L4V 1N1

Additional Information

Certificate of Attendance: All participants will receive a certificate of attendance upon completion of the course Registration Fee Includes: Presentation Materials, Luncheon, Refreshments and Parking