Category GMDP

Another ex MHRA Inspector Joins the EPiC Team

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

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

EPIC Auditors are delighted to announce that ex MHRA Inspector 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 pharma compliance 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.

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

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 pharma compliance conference 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