EPiC Auditors Autumn Compliance Seminar: Thursday 10th November 2022
Here’s what our seminar speakers have to say about the event;
“A condition of holding an MIA and WDA(H) is that the guidelines on GMP and GDP are complied with. Sustaining the required level of compliance is a must to ensure medicinal products of the right quality are manufactured and distributed and avoid regulatory action. My presentation on Future-proofing compliance will explore what licence holders can and should do to continually improve and not only fulfil but exceed this requirement.”
Richard Andrews, EPiC Auditors Managing Director & Senior Consultant
With the deadline for the implementation of Annex1 fast approaching, now is a great time to consider the implications for your sterile processes. At the EPiC Autumn Compliance Seminar, I will roadmap those areas of the new Annex 1 that may result in many future sterility assurance deficiencies – a roadmap of the hotspots. This session will complement the session from Rick Parker of the MHRA, who will provide the latest MHRA thinking on Annex 1. A great opportunity to get ahead of the Annex 1 changes!
Darren Jones, EPiC Auditors Director & Senior Consultant
To find out more about the seminar and to book your tickets click on the link below:
What was it?
This online seminar was a full day delivered remotely comprising a variety of ex MHRA Inspector speakers with invited guest speaker Richard Parker, Senior GMDP Inspector at the MHRA who will be delivering an MHRA update on Annex 1 with a regulators view of the changes.
Altogether was a thought-provoking and informative day which aimed to:
- Share recent changes and updates to the GMP and GDP Guidelines and Regulations with particular focus on Annex 1.
- Highlight changes to inspection practices and MHRA oversight.
- Discuss tools and practices to maintain compliance.
- Present current and future Annex 1 deficiencies, along with the pitfalls to avoid.
- Provide insight into the changes arising from the implementation of the Clinical Trials Regulations and points to consider around the IMP / GCP Interface.
- Explore the challenges and considerations when moving from an R & D to a GMP Environment.
This event provided updates and information on recent changes to guidelines and regulations as well insights into current deficiency trends and inspection practices.