Annex 1, EudraLex Volume 4: Where are we regarding the time to implementing the new requirements?
Dec 8, 2022 9:00am ‐ Dec 8, 2022 9:30am
Annex 1, EudraLex Volume 4: Where are we regarding the time to implementing the new requirements? |
Setting the Stage for eData Exchange
Dec 8, 2022 9:00am ‐ Dec 8, 2022 9:30am
Setting the Stage for eData Exchange |
Single-Use Systems Characterisation – How Standardised Extractables Data Support E&L Risk Assessment
Single-Use Systems Characterisation – How Standardised Extractables Data Support E&L Risk Assessment
Dec 8, 2022 9:30am ‐ Dec 8, 2022 10:00am
Single-Use Systems Characterisation – How Standardised Extractables Data Support E&L Risk Assessment |
Revolutionizing Visual Inspection through Artificial Intelligence
Dec 8, 2022 9:30am ‐ Dec 8, 2022 10:00am
Revolutionizing Visual Inspection through Artificial Intelligence |
New Annex 1 Challenges for LVP Bag Manufacturing
Dec 8, 2022 10:00am ‐ Dec 8, 2022 10:30am
New Annex 1 Challenges for LVP Bag Manufacturing|
Standardized Integration for Lab Robots
Dec 8, 2022 10:00am ‐ Dec 8, 2022 10:30am
Standardized Integration for Lab Robots |
Pharma 4.0TM 6th Survey: Latest Results and Trends
Dec 8, 2022 11:00am ‐ Dec 8, 2022 11:30am
Pharma 4.0TM 6th Survey: Latest Results and Trends |
Regulatory Panel: Annex 1 Implementation
Dec 8, 2022 11:30am ‐ Dec 8, 2022 12:30pm
Regulatory Panel: Annex 1 Implementation |
The updated Annex 1 has been released end of August, introducing changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. In this panel, Regulators will discuss those changes and how they impact our manufacturing practices and consider how Pharma 4.0ÿ concepts such as data management and clean room monitoring can assist with Annex 1 implementation. More work is now needed to bring clarification which could be needed in the future for a better implementation of this new document, training for all stakeholders and regulators will be needed to have an harmonized application of the new Annex 1.
Reflection - Presented by ISPE Women in Pharma™
Dec 8, 2022 12:45pm ‐ Dec 8, 2022 1:30pm
Reflection - Presented by ISPE Women in Pharma™ | Join us for a roundtable discussion focused on Reflection where attendees can discuss and reflect on their experiences to encourage the development of relationships and the sharing of ideas and professional advice. The format will be interactive roundtable discussion style with questions and topics at each table.
Regulatory View on the Holistic Control Strategy and Digital Maturity
Dec 8, 2022 1:30pm ‐ Dec 8, 2022 2:00pm
Regulatory View on the Holistic Control Strategy and Digital Maturity |