FDAnews Announces — Permitted Daily Exposure/Acceptable Daily Exposure Values: The New Acceptance Criteria in Cleaning Validation Webinar Sept. 29, 2020

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Stay compliant with new cleaning validation PDE/ADE acceptance criteria. Set limits and pass FDA and EU inspections.

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WCG FDAnews

Permitted Daily Exposure/Acceptable Daily Exposure Values:
The New Acceptance Criteria in Cleaning Validation
An FDAnews Webinar
Tuesday, Sept. 29, 2020, 11:00 a.m.-12:30 p.m. EDT
https://www.fdanews.com/pdeade

Does one’s cleaning validation processes still pass muster with the FDA and EU authorities?

Recent revisions to permitted daily exposure (PDE) guidelines for setting limits in cleaning validation mean teams have to establish new processes.

Current FDA warning letters show rigorous enforcement. Plus, revisions have come from the American Society for Testing and Materials (ASTM), the European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). All have required drugmakers to establish health-based exposure limits (HBELs).

What are the best ways to implement the current requirements and maintain compliance?

Pharmacist Sabine Paris, PhD — a senior GMP expert and chief editor of GMP Compliance Adviser — has the answers in this webinar. Dr. Paris will explain how to implement the current requirements for setting limits in cleaning validation, including how to come up with a scientific, substance-specific justification for the limit value calculation for active substance and cleaning agent residues.

Using a case study from inspection practice, she will share:

  • The new requirements of EMA, PIC/S and ASTM PDE Guidelines
  • The complex derivation of PDEs
  • Important aspects of PDE reports
  • The disadvantages of the traditional acceptance criteria (10 ppm, 1/1000 doses)
  • Implementation of PDEs in cleaning validation
  • The risk identification in a multipurpose facility
  • Alternatives to PDEs
  • Expectations of Good Manufacturing Practices (GMP) inspectors

Stay compliant and stand up to the most rigorous cleaning validation reviews.

Interested in registering multiple sites?
Call 888.838.5578 in the U.S. or +1 703.538.7600 globally
to learn about our special multisite discount.

Webinar Details:
Permitted Daily Exposure/Acceptable Daily Exposure Values:
The New Acceptance Criteria in Cleaning Validation
An FDAnews Webinar
Tuesday, Sept. 29, 2020, 11:00 a.m.-12:30 p.m. EDT
https://www.fdanews.com/pdeade

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/pdeade
By phone: 888.838.5578 or 703.538.7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

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Michelle Butler
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