FDA’s New Sterilization Pilot on Risk-Based Cleaning and Disinfectant Programs – Webinar Recording/Transcript
Product Details
The deadline for implementing new guidelines on the manufacture of sterile medicinal products is approaching. Is your preparation plan in place?
To be sure you are ready, attend this webinar led by Jim Polarine, a senior technical service manager at STERIS Corporation, who will offer a comprehensive action plan on how to design a holistic cleaning and disinfection program.
During this webinar, you’ll explore the highlights of FDA and international regulations, such as the EU GMP Annex 1 on the manufacture of sterile medicinal products, and industry guidance documents, including the Parenteral Drug Association’s (PDA) Technical Report No. 70, Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities. You will come away with a greater understanding of how to comply with new regulations in keeping control in cleanrooms to ensure the development of safe, pure and effective drug products.
Presentation Takeaways:
- Cleaning and disinfection best practices in the industry
- A comprehensive understanding of how to develop a holistic contamination control strategy that includes an effective risk-based cleaning and disinfection program
- A review of new EU GMP Annex I regulations, cleaning and disinfection guidance documents, including USP 43 <1072>, PDA Technical Report No. 70, and other industry guidance documents
- The latest advancements in application equipment and methods of cleaning
- Lessons learned from recent FDA warning letters and Form 483s
If you want to stay current on all new cleaning and disinfection regulations impacting control in cleanrooms — don’t miss this chance to gain key insights from a top expert in the field.
Meet Your Presenter
Jim Polarine is a senior technical service manager at STERIS Corporation. He is a co-author of PDA’s Technical Report No. 70 and Technical Report No. 88 on microbial deviations. He currently teaches cleaning and disinfection as part of PDA’s aseptic processing course at the Institute of Environmental Sciences and Technology and at the University of Tennessee’s parenteral medications course.
Who Will Benefit
- Validation
- Quality control
- Quality assurance
- Quality systems
- Operations
- Cleanroom
- Regulatory affairs
- Production
- Continuous improvement
- Business development