In the EU, Annex 1 describes the regulatory expectations for these aseptic processes and facilities. Over the last 7 years, there has been a revision to the 2009 rendition of the Annex. It was finally published in 2022 and represents a major step forward on the expectations for processes and facilities. In this live training session, we will explore what has changed in the Annex and discuss the implications for your operations whether it is in North America, Europe or the rest of the world. Products today are made in one location but exported worldwide so the highest standard expectation is the default if you want to stay in the market. The implications for already approved facilities as well as new construction will be discussed.

Learning Benefits:

• Understanding how the requirements for aseptic and sterile operations have changed in the EU and beyond.
• Regulations as they stand EMA and FDA.
• The movement towards building more assurance into sterile product manufacture.
Keeping you abreast of potential future trends in aseptic operations.
• Understanding the mind-set of the EMA.
• How risk management plays a big role in facility design, construction, and operation.
• Understanding whether my older facilities and processes will be grandfathered or must we upgrade.
• Gives the tools for auditors to understand what is acceptable or no.
• Understanding how we must plan ahead in our supply chain, so we are not left with an unprovable facility or operation.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Live Presentation Part 1

11:30 AM Break

                Live Presentation Part 2

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A certificate of participation for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Quality Professionals
• Validation Engineers
• Facility and Design Engineers
• Manufacturing Professionals
• Regulatory Compliance Professionals
• Technical Operations Staff
• Regulatory Affairs Staff

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.