News

MICHELLE YEOMANS TO JOIN EPIC AUDITORS IN APRIL

Another ex MHRA Inspector Joins the EPiC Team

EPIC Auditors is very pleased to announce that Michelle Yeomans will be joining us on 7th April to fulfil the role of EPIC Auditors Operations Manager. 

Michelle Yeomans

EPIC Auditors was established in 2014 by Liz Allanson and Darren Jones (both ex MHRA) to fulfil the increasing need for ex MHRA Inspectors to conduct mock regulatory inspections and to provide consultancy advice from the Regulatory perspective. The company has developed considerably over the last 8 years and Michelle has been appointed to further strengthen the management team and assist with the day to day operation of the business.

Michelle is well known to the pharmaceutical industry having been in the MHRA GMP/GDP management team for many years and been a familiar face at many MHRA GMP/GDP and GCP Symposia.  Michelle has completed 17 years in the MHRA starting as a GCP Inspector, progressing to Senior Inspector and gaining accreditation for GMP inspections of manufacturers of clinical trials, before moving to become a GMDP Operations Manager and ultimately the GMDP Inspectorate Unit Manager.

Michelle brings to EPiC not only the considerable length of service in the MHRA, at both Senior Inspector and senior management level, but also excellent organisational skills, and 19 years previous experience working and auditing in the pharmaceutical industry.  Michelle held positions in Technical and QA roles with various pharmaceutical companies and operated as an IMP Transitional QP prior to joining the MHRA.

Over the years Michelle has engaged extensively with the industry and we are sure this will continue as she works with our clients to help them to improve their GXP quality systems and regulatory compliance.

We are really excited about Michelle joining our team, and acknowledge the skills that she will bring to improving our own quality systems as well as those of our clients.

You can read more about Michelle’s background and qualifications as well as meet the rest of the EPiC Auditors Team here: Meet The Team

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

EX MHRA INSPECTORS STEPHEN GRAYSON JOINS THE EPIC TEAM

EPIC Auditors are delighted to announce that Stephen Grayson has joined the team as an independent consultant.

Stephen has over 39 year’s pharmaceutical industry experience in manufacture, packaging, auditing and inspection, fourteen spent working for the MHRA, where he held the post of Senior GMDP Inspector. He is widely known across the industry and has extensive experience of GMP inspections, having completed more than 500 in the UK and over 300 in third countries.

Stephen was trained and accredited by the MHRA to inspect:

• Collection, processing, testing and distribution of blood and blood components
• Sterile and non-Sterile manufacturing sites (all dosage forms).
• NHS and commercial “Specials” manufacture, including sterile product.
• Sterilisation processes including irradiation, ethylene oxide, moist heat and dry heat.
• Sterile API manufacture.
• Wholesale dealers (storage and distribution).

With his comprehensive portfolio of experience, Stephen is an excellent addition to the EPIC team. We are confident we can provide you with GXP support across the medicinal product lifecycle and help all our clients improve their GXP quality systems and regulatory compliance.

Stephen Grayson
Stephen Grayson ex MHRA Inspector

Pharmaceutical Industry Experts

Auditors used by EPIC are former Regulatory Inspectors, typically ex MHRA Inspectors. All auditors have extensive industry experience and many years of experience auditing and inspecting within the pharmaceutical industry.

To read the bio and full CV for Stephen and our other experts’ visit Meet Our Experts

MHRA Speaker Confirmed

We are very pleased to announce that Michelle Yeomans, GMDP Inspectorate Unit Manager at the MHRA will be delivering a Regulatory Update at the forthcoming GMP symposium.

Michelle will be covering the Clinical Trials Regulation and what it means to the UK, share the latest on the NI Protocol and the discussions with the EU, give an update on the transformation of the agency and highlight the top 10 deficiencies arising from GMP Inspections during 2021.

On receiving confirmation of Michelle’s participation Richard Andrews, EPIC Auditors Managing Director commented ‘we are extremely privileged to have somebody of Michelle’s standing and experience to present at the symposium. It offers a real opportunity for all delegates to receive the most current information on the changes facing the industry.’

This virtual symposium 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 insight into what you might have missed since the start of the pandemic. 

To find out more and to book your place follow the link here

BACK TO THE PRESENT: EPiC Auditors First Virtual GMP Symposium

EPiC Auditors Virtual GMP Symposium 2022

We at EPiC Auditors Ltd will be running our very first virtual symposium on Tuesday 1st February 2022. The theme is Back to the Present; an opportunity to see what you’ve missed during the pandemic and what’s on the horizon.

This virtual symposium 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, with a few laughs along the way.

The EPiC GMP Symposium 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 day will provide you with the latest information and guidance on changing legislation and give you insight into what you might have missed since the start of the pandemic. Through presentations on current deficiency trends and an IAG case study, you will learn how to maintain a compliant PQS and better manage remote inspections.

Richard Andrews, Managing Director and Senior Consultant for EPiC says, “We are really excited to be delivering this symposium and to be sharing the collective knowledge of the ex-MHRA Inspectors working for EPiC Auditors. The regulations, guidance and expectations are continually evolving and companies need to ensure they stay up to date to remain compliant.”

Tickets cost £250.00 and include Multi-attendee discounts – book one place at the full price and book up to three further places at the same time at a 50% discount.

This event is brought to you in collaboration with SeerPharma UK

To buy tickets follow the link below.

ARE YOU HEADING FOR IAG?

Trust us: IAG is not an acronym that you want to be too familiar with. It stands for Inspection Action Group, the multidisciplinary team at the MHRA that determines whether your organisation maintains or loses its manufacturing or wholesale dealers licence.

It may be surprising to some of you that after 50 years plus of pharmaceutical legislation and GMP/GDP regulations that 3-4 companies a month still find themselves being referred to IAG with the potential of having their licences suspended or coming under strict and costly surveillance by the MHRA Compliance Management Team.

However, this is not so surprising to us in the EPIC Auditors team. Most of us are ex MHRA Inspectors, and we know only too well that any change in the Senior Management of a company can have a significant effect on the quality mindset and compliance level of a site.

Hopefully it will be for the better but sadly all too often it is for the worse. Most of the companies that we work with require our help because the quality focus at senior level is inadequate. It is still rare to see a Quality Director on the Board of Directors and this role should be seen as important as that of the Finance Director and Operations Director. If all Senior Management Teams had the Quality training and Quality understanding required to run the business in a cost effective and compliant manner, then we might see a reduction in IAG cases at MHRA.

It is our opinion that anyone appointed to a Senior Management Team role should undergo mandatory training in Quality Management and ICH Q 10 principles.  Those companies that we have provided this training for will hopefully endorse our thinking. It is a requirement of GMP that all employees have training in Quality Management and this includes the Senior Management Team. Failures to implement an appropriate Pharmaceutical Quality System and to conduct suitable and effective quality management reviews with the involvement of senior management, feature in the top 10 deficiencies raised by MHRA year on year. Ensuring the Senior Management Team are aware of and are trained in their quality role and responsibilities, should lead to fewer companies facing the threat of IAG.

Senior management team