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 webinar presented by EU regulatory experts Londa Ritchey, director and principal consultant QMC, Cencora PharmaLex, and Patrick Nieuwenhuizen, director and senior consultant, PharmaLex Ireland, attendees 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.

Webinar 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. Attend the webinar, take the information back to your team, and devise an immediate plan for success.

Who Will Benefit:

  • Aseptic/sterility assurance leads
  • Microbiologists/QC staff
  • QA staff
  • Operations staff
  • Engineering/facilities staff