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

Registrations are now open for EPiC’s Autumn Compliance Seminar:

Thursday 10th November 2022

Shaping a Pharma Compliant Future

After the success of our GMP Symposium in February, EPiC Auditors are pleased to announce that we will be delivering a virtual compliance seminar on Thursday 10th November 2022.

The theme is Shaping a Pharma Compliant Future – How to achieve and demonstrate sustainable compliance.

This online seminar will be a full day delivered remotely comprising a variety of ex MHRA Inspector speakers with an invited guest MHRA GMDP Inspectorate speaker. Altogether it will be a thought-provoking and informative day!

The outline agenda includes;

• Recent Updates to Guidelines and Regulations
• Assessing and Demonstrating Compliance
• Tools to maintain compliance
• Current and future Annex 1 deficiencies
• The IMP/GCP interface
• Future-proofing compliance
• Considerations when moving from R&D to GMP
• GDP controls and expectations for importation

**Re-visit our website here to see the full the details and agenda as it develops**

You can now buy your EPiC Autumn Compliance seminar tickets for £250 + VAT

Click on the button below to register and pay online:

In collaboration with SeerPharma UK

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

EPiC Auditors are excited to announce that they will be delivering an Autumn Compliance Seminar on 10th November 2022 focusing on shaping a compliant future.

This will be an online event. Further details about the speakers and agenda will be published on this page over the coming weeks.

This event has already taken place. What was the event about?

The online seminar, delivered remotely over a complete day, featured a diverse lineup of ex-MHRA Inspector speakers. Among them was Richard Parker, Senior GMDP Inspector at MHRA, who provided an update on Annex 1 from a regulator’s perspective. The day was filled with insightful and thought-provoking discussions aiming to:

• Disseminate updates and recent changes in GMP and GDP Guidelines and Regulations, especially Annex 1.
• Illuminate alterations in inspection practices and MHRA oversight.
• Delve into tools and strategies for maintaining compliance.
• Reveal current and future deficiencies in Annex 1, along with pitfalls to steer clear from.
• Offer insights into changes resulting from the Clinical Trials Regulations implementation and points to contemplate about the IMP / GCP Interface.
• Examine the challenges and considerations during the transition from an R&D to a GMP Environment.

The seminar offered updates and information regarding recent amendments to guidelines and regulations, as well as insights into current deficiency trends and inspection practices.

MHRA Inspectorate Blog has recently published Part 2 in the Compliance Monitor Process series with further information about the Compliance Monitor (CM) role and application process.

The blog can be found here: Compliance Monitor Process (Part 2)– CM role and application process

The blog acknowledges that it is common for companies that are at IAG to employ consultants to assist with remediation activities, and this is something that EPiC has extensive experience of supporting including reporting on progress to MHRA. The application process for an individual to apply for the CM pilot programme to be named on a register will be based on an eligibility assessment by MHRA considering career history, relevant experience, not having been personally the subject of MHRA regulatory action and/or significant adverse findings in the previous 3 years, and the need to have completed relevant training in the CM process. Eligible CM’s will then be assessed by MHRA for suitability on a case-by-case basis when they are nominated by a company, to confirm that they have sufficient experience of the dosage forms and site operations and that there is no conflict of interest. 

In response to the recent MHRA Inspectorate Blog post, Richard Andrews commented “It is good to see that both eligibility and suitability of the CM are being assessed which draws parallels from the naming of Qualified Persons (QPs) on UK manufacturing licences. Although a QPs eligibility to be named may be assessed by the Joint Professional Bodies, MHRA, or an EU regulator, their suitability to be named on a specific UK manufacturing licence is assessed and decided by MHRA based on site-specific knowledge and experience, which is above and beyond their eligibility assessment. The same two-stage approach will help to ensure CMs will have the background experience and site-specific knowledge to assess risks to product quality and patients in developing and overseeing remediation plans and assisting with implementation. This type of remediation work is a core service we offer at EPiC and is why our consultants will be applying to be named as CMs.”