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.

“you say tomato, I say tomahto” ????

Regardless of what we are calling our Autumn Compliance Seminar/ Symposium!

This online conference will be a full day event delivered remotely, packed with a programme of informative sessions and presentations brought to you by current & ex MHRA Inspectors, providing pharmaceutical compliance advice across a wide range of hot topics guaranteed to get you thinking and an opportunity to start a discussion and ask your own burning questions! ????????????

Unlike other conventions, our seminar on Thursday 10^th November will not be a lecture but a thought provoking and informative colloquium with a few laughs along the way!

There’s only 2 weeks to go – don’t suffer FoMo, be sure not to miss out!

Get your tickets here;

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

EPiC Auditors Autumn Compliance Seminar: Thursday 10th November 2022

Here’s what our speakers have to say about the pharma compliance event;

 “How to achieve Regulatory compliance for small, new and innovative companies can seem an impossible task. How to maintain pharma compliance for well established global companies can be equally challenging. We hope this seminar provides some useful advice and solutions for all pharmaceutical companies, whatever stage of maturity they are at. We look forward to delivering our second online conference and sharing our thoughts gained from our previous MHRA experiences, as well as from our recent projects within EPIC.”

Liz Allanson, EPiC Auditors Director and Senior Consultant

The transitional measures in place to support implementation of the Clinical Trials Regulation which replaces the Clinical Trials Directive are rather complex, and it can be confusing for clinical trial teams to know which sets of documents and requirements should be referred to depending on the location and legislation under which the clinical trial is conducted. This presents risks to compliance and a need for Sponsors to ensure that they have adaptable systems to cope with the flexibility of risk proportionate approaches proposed by MHRA, without overlooking trial specific or regulatory requirements for EU trials. At our Autumn Pharma Compliance Seminar, myself and Louise Mawer (ex MHRA Senior GCP Inspector) will be providing practical advice and real-world examples for Sponsors and clinical trials teams on key aspects of managing clinical trial activities during the legislative transitional phase.We will also be reflecting on the challenges for clinical trial supply chains following the UK’s exit from the EU, to help those involved in clinical trial supply understand the GMP expectations for IMPs, non-IMPs and QP certification requirements. The transitional implementation phase of the Clinical Trials Regulations has presented additional challenges at the IMP/GCP interface, and we hope our session will raise awareness of the different terminology and expectations to help maintain compliance with the changing requirements.

Michelle Yeomans, EPiC Auditors Operations Manager  

To find out more about the seminar and to book your tickets click on the link below:

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

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