Category Annex 1

With just over 3 weeks to go until the EPiC Autumn Pharma Compliance Seminar on Thursday 10^th November 2022 we have released a copy of the whole day’s agenda.

Here’s a summary of what is covered:

• Guest speaker Richard Parker, Senior GMDP Inspector at the MHRA will be delivering an MHRA update on Annex 1 with a regulators view of the changes.
• Richard Andrews (EPiC & ex MHRA GMP Inspector & Unit Manager) will be your host for the day as well as giving an overview of recent updates to guidance & regulations and how to future proof your compliance.
• Michelle Yeomans (EPiC Operations Manager and ex MHRA GMDP Inspectorate Unit Manager) will be reviewing the direction of travel for compliance and speaking to Louise Mawer (ex MHRA Inspector) about the implementation of the Clinical Trials Regulation and overcoming challenges at the IMP/GCP interface.
• Darren Jones (EPiC & ex MHRA Inspector) will explain how to develop your PQS and move from remediation to sustainable compliance, as well as discussing current and future Annex 1 deficiencies and the  the pitfall to avoid.
• Liz Allanson (EPiC & ex MHRA GMP Inspector) will give a presentation on points to consider when moving from an R&D to a GMP environment.
• Guest speakers Gaynor Brummitt (SeerPharma UK & ex MHRA Senior GDP Inspector) & Shahbaz Sarwar (SeerPharma UK ex MHRA GDP Inspector) will be explaining Importation and the Role of the RPi.       
• There will also be a Q&A session where a panel drawn from the speakers will answer questions submitted throughout the event.

Download the Agenda here:

The day promises to be of real interest to pharmaceutical industry professionals involved in the manufacture and supply of medicines and aims 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. 

How to secure your place

Tickets are now available to buy online and cost £250.00 + VAT

Click on the button below to register

Any booking enquiries, please email: enquiries@epic-auditors.com

In collaboration with SeerPharma UK

You may also be interested in the SeerPharma UK GDP Symposium taking place on Tuesday 8^th November 2022: Register and Pay Online Here

We are very pleased to announce that Richard Parker, Senior GMDP Inspector at the MHRA will be delivering an MHRA update on Annex 1 with a regulators view of the changes at the forthcoming EPiC Auditors GMP Compliance Seminar on 10^th November 2022.

Rick joined the MHRA in January 2016. Prior to this Rick was a GMP Inspector at the Veterinary Medicines Directorate for 10 years and has a wide range of expertise in the GMP area with knowledge of all types of medicines manufacture. 

On receiving confirmation of Ricks participation Richard Andrews, EPIC Auditors Managing Director commented:

“we are extremely privileged to have somebody of Rick’s standing and experience to present at the seminar. It offers a real opportunity for all delegates to receive the most current information on the changes facing the industry.”

This virtual seminar will be a full day delivered remotely and is ideal for pharmaceutical industry professionals in quality control, quality assurance, supply chain and production management, as well as Qualified Persons, regulatory and compliance specialists involved in the manufacturing of medicines.

The event will provide the latest information and guidance on changing legislation and give you insights into current and future Annex 1 deficiencies – Pitfalls to Avoid and how to demonstrate and future proof compliance.

To find out more about the seminar and to book your place follow this link