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

Cyber Essentials Accreditation

This month, Epic Auditors are proud to announce that they have achieved certification from Cyber Essentials proving their dedication to guard against cyber threats and demonstrate a commitment to cyber security.

What is Cyber Essentials?

Cyber Essentials is an official UK, Government backed scheme that encourages organisations, of all sizes to adopt best practice in information security and ensures they take sufficient measures to prevent against the risks of possible threats against a whole range of cyber attacks.

This certification is awarded by means of an independent assessment of the business security controls and processes, it also gives peace of mind that company defences will protect against the vast majority of common cyber-attacks. Receiving this accreditation shows that EPiC Auditors have addressed those basics to prevent the most common attacks within their systems.

Richard Andrews, Managing Director of EPiC Auditors commented “Achieving the Cyber Essentials certification is crucial in ensuring our cyber security is as strong as possible to protect our clients’ sensitive data. Our clients can have the confidence and trust that we are following best practice guidelines and recognise the importance of keeping their information safe and our IT systems secure.”

EPIC Auditors are dedicated to investing in its cyber security and will continue to adopt best practices in their information security strategy to ensure that the data we hold is managed properly and kept in a secure and safe digital environment.

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

5 Top Tips for Calibration Success

Article By Darren Jones, Director & Senior Consultant for EPiC Auditors

Calibration is an often-overlooked area of the PQS; many calibration certificates are incorrect or don’t contain adequate detail and in many cases are not understood by the site experts!

Calibration services are frequently outsourced and I often find that key GMP decisions have also been inappropriately outsourced as well! Does the calibration company set the limits? Who determines how and when out of specification results are reported?

Many certificates do not state Pass or Fail… Why not? The certificates often just contain the limits and the data. I regularly find calibration results that do not comply with the limits- the calculations have not been done and no one in the Pharma company has checked the data!

Limits are sometimes specified as +/-2% of FSD (full scale deflection). What does this mean? Often the method of calculating this is not clear and the calculations used to determine this limit are not recorded or checked.

Given accurate instrumentation is key to achieving process control, which ultimately assures product quality, calibration requirements need to be understood and properly managed.

Tips for success:

1. Use multi-point calibration over the working range of the instrument.
2. Ensure you set, or at least approve the limits applied during calibration, don’t leave this just to the contractor.
3. Have a contract with the provider that includes instruments, frequency, limits, ranges and out of specification results reporting. Appendices containing tables can be useful to manage the detailed information.
4. Ensure results are reported as found and as left, i.e. pre and post any adjustment, you don’t want to miss a failed as found result.
5. Ensure limits are clearly understood. The SOP should show how to calculate limits e.g. based on FSD and these calculations should be documented and checked as per any other important calculation.  Evaluate the limits using Pass/Fail criteria.

If you need our help and support then please don’t hesitate to contact us.

Telephone: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com