Inspection Readiness for EU GMP Annex 1 – Manufacture of Sterile Medicinal Products – Webinar Recording/Transcript
Product Details
During facility inspections, manufacturers of sterile medicinal products face increased scrutiny when it comes to compliance with the new GMP guidelines outlined in EudraLex Volume 4, Annex 1. It’s been almost a year since compliance was required by EU authorities, but many companies find it a challenge to interpret and implement the new measures.
In this FDAnews presentation by EU regulatory experts Londa Ritchey, director and principal consultant QMC, Cencora PharmaLex, and Patrick Nieuwenhuizen, director and senior consultant, PharmaLex Ireland, listeners will get practical knowledge on how to navigate the new requirements, discuss how Annex 1 compares to the FDA’s 2004 guidance on the manufacture of sterile medicinal products, and learn how to be ready for an inspection by EU regulators.
Presentation Takeaways:
- Gain a clear grasp of the key elements of Annex 1.
- Find out how to assess your company’s level of Annex 1 compliance, and prepare a remediation plan.
- Acquire practical advice on using risk management methods, and developing a contamination control strategy.
- Create a preparation plan for an inspection by the regulatory authorities.
- Immerse yourself in what can be learned from current inspections related to sterile manufacturing.
Two recognized EU experts in sterile medicinal product manufacturing and regulatory compliance promise to shed light on a complex topic. Listen to the presentation, take the information back to your team, and devise an immediate plan for success.
Meet Your Presenters
Londa Ritchey, director and principal consultant QMC, Cencora PharmaLex, has 30 years of experience in pharma/biopharma quality assurance emphasizing sterile drug substance and drug product operations. Her experience includes quality risk management, quality systems design and implementation, contamination risk management, supplier quality management and inspection readiness.
Patrick Nieuwenhuizen, director and senior consultant with PharmaLex Ireland, is a quality professional with more than 25 years’ experience in the pharmaceutical industry, including sterile manufacturing activities. He served in various quality roles for several global pharmaceutical and biotechnology companies across a variety of platforms, including biologics, vaccines and solid oral dose. A qualified lead auditor and risk facilitator for quality risk management, he is coauthor of the PDA Technical Report on “Contamination Control Strategy” and a regular presenter at international conferences.
Who Will Benefit
- Aseptic/sterility assurance leads
- Microbiologists/QC staff
- QA staff
- Operations staff
- Engineering/facilities staff