The Essentials of Cleaning Validation for Pharmaceutical Manufacturers | Nov. 15, 2 PM EDT | Phillips
August 28th, 2013 // 2:05 pm @ jmpickett
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.
What You Will Learn
- 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
What Is Included
With your order, we would like to offer you these six items at no added cost:
- Powerpoint slides to share
- Downloadable recording
- Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
- Article – 10 Ways to Control Compliance Costs – By John  Avellanet, Cerulean Associates
- Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
- Newsletter – FDA Digest – By Expertbriefings.com. Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00
About the Speaker:
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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