Pharmaceutical Cleaning Validation
Instructor:
Jeff Phillips
Product ID: 700915
- Duration: 60 Min
Cleaning Validation is a timely topic that should concern all pharmaceutical manufacturers and subcontractors. Surface contamination and critical cleaning must be understood in order to have an effective, well thought out cleaning validation program. This webinar will cover the concepts of critical cleaning, FDA requirements and cleaning validation. Attention will be paid to understanding cleaning from a chemical, substrate and throughput point of views. Also covered will be how to approach the question of how clean is clean.
Areas Covered in the seminar:
- How do I prove to the FDA that my cleaning program is well understood, defined and robust?
- How to Calculate MACO.
- How does one chose cleaners?
- What is critical cleaning?
- What are the FDA regulations/guidance relating to pharmaceutical manufacturing as related to critical cleaning and cleaning validations?
- How does one approach the Holy grail question of how clean is clean?
- Looking at validation of cleaning processes.
- How does one establish a cleaning program?
Who will benefit:
This webinar will enable one to approach issues surrounding cleaning validation. Regulated companies in the pharmaceutical as well as biotechnological, combination and pharmaceutical industries will benefit from the information transmitted. The employees that will benefit the most include:
- QE managers and personnel
- Operations managers and personnel
- Validation specialists, especially cleaning validations
- Consultants
- Quality system auditors and Vendor auditors
- AR&D managers and personnel
- QC managers and personnel
Jeff Phillips, is a primary investor and Principal Consultant with Atzari Consulting. A firm that specializes in management consulting for the medical device, pharmaceutical, combination and biotechnology industries. Jeff has established cleaning processes and procedures. He has lectured in many countries around the world on cleaning validation topics. Jeff started an analytical laboratory and established policy concerning critical cleaning and cleaning validations. He has over 12 years of experience in the pharmaceutical and medical device industries. He has consulted with and assisted major detergent companies on how to best serve theses industries.
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