Cleaning Validation for Drugs and Biologics Strategies for Managing Your Biggest Compliance Challenge
Product Details
Ten companies have already run afoul of 21 CFR 211 cleaning and validation compliance. For one — Sumitomo Chemical — it was the design of a machine that’s been in widespread use since 1990.
Your facility could be next. That’s why it’s critical to clarify and comply with requirements for cleaning solvents, equipment design, training programs, validation and more.
Do you fully understand the FDA’s cleaning and validation requirements for equipment and utensils that come in contact with drugs and biologics?
Judging by what’s turning up during inspections, the FDA is being very clear that many firms don’t. Over the past 12 months, serious enforcement actions have included:
- Product recalls: Non-sterility prompted a voluntary recall of all lots of Sagent Pharmaceuticals’ antimicrobial metronidazole.
- Form 483s: The FDA cited King Pharmaceuticals for environmental control violations; machine breakdowns contributed to violations at Nycomed; deficient sanitation and validation were issues for Chem-Tech; incorrect acceptance criteria for leak tests were among nine violations cited at Ben Venue Laboratories; and University of Iowa Pharmaceuticals’ validation and training failed to pass muster.
- Warning letters: GDMI failed to validate its cleaning procedures; Sumitomo Chemical’s equipment design mandated manufacturing changes; and repackager Apotheca was cited for the potential of cross-contamination.
Don’t take the chance of being the next violator in the FDA’s line of fire. Instead …
Attend this exclusive one-day Virtual Summit, and learn how your cGMPs must change.
At Cleaning Validation for Drugs and Biologics, you’ll hear leading industry experts explain exactly what regulations apply and how to make your equipment and processes “violation-proof” before FDA inspectors arrive.
You’ll benefit from real-time PowerPoint presentations and real-world examples and case studies. You’ll have the opportunity to ask the experts your own questions.
But it’s all in the convenience of your own office or conference room — with your entire team in attendance if you choose — and no travel or hotel expenses.
Step by step, our expert speakers will help you translate the FDA’s expectations into real-world practices, including how to:
- Align your cGMPs with 21 CFR Part 211 and ICH quality guidelines
- Relate cleaning validation to the FDA’s new process validation guidance
- Calculate acceptable cleaning validation limits
- Set appropriate limits for API, detergents and cleaning agents
- Integrate cleaning and validation requirements into equipment design considerations
- Measure, inspect and monitor the sanitation processes of manufacturing equipment
- Mesh cleaning within a total environmental monitoring program
- Create a cleaning validation master plan — including training documentation
- Prepare airtight documentation for cleaning processes, sampling locations and cleaning agents
- Streamline cleaning validation methods with a strong QbDE strategy
- Identify critical operating restrictions to set the most successful operating ranges
Tap into the expertise of six experts on validation and FDA compliance
The summit chair is Rich Yeaton, president of East Coast Validation. Mr. Yeaton has more than 20 years of experience working in FDA-regulated industries. He recently helped Avecia Biologics, a microbial fermentation contract manager, prepare successfully for its first preapproval inspection.
He was initially introduced to GMP operations and validation on the devices side as a development engineer in DuPont’s Medical Products divisions. From there, he helped start Phoenix Imperative, an engineering and validation company serving the biopharmaceutical industry, where he led validation teams at two cell culture facilities to help MedImmune obtain its first two commercial licenses.
Mr. Yeaton has since worked with small startup companies as well as Merck, Genzyme, Wyeth and Lonza, gaining in-depth experience with facility shutdowns and startups. He is a member of the ASME, the ISPE and the PDA and holds degrees in electrical and mechanical engineering from Lehigh University.
He will be joined by a team that includes a senior cleaning validation specialist, engineer, scientist, and two leading industry validation and compliance consultants.
Click here to view the agenda!
Trouble-shooting training for your entire team — with no need to travel!
No need to pack your bags for this summit — it’s virtual. Cleaning Validation for Drugs and Biologics uses the Internet and advanced audioconferencing technology to bring a dynamic summit right to your laptop or conference room.
From content-rich PowerPoint presentations by industry experts to handouts, Q&As and breaks, this all-day session will feel just like a powerhouse conference!
The difference? Bring your entire staff for one flat fee with zero hotel and travel costs.
There’s even a 24/7 ENCORE presentation included. So, you and your staff can dial in again at any time of day or night for three full weeks after the original summit.
Have everyone attend the full program or assign specific sessions. Either way, you’ll come away with smart new strategies that will reduce the delays, frustration and risk of conducting clinical trials in the EU.