Lewis Corbett joins EPiC as Business Manager & Senior Consultant

EPIC Auditors are delighted to announce that Ex MHRA Inspector Lewis Corbett has joined EPiC Auditors as Business Manager and Senior Consultant.

Lewis has over 25 years experience of pharmaceutical manufacture and distribution gained from working within the industry and for the GMP Inspectorate of the UK medicines regulator (MHRA) as a Senior GMP Inspector and Head of GMP Team 1. During his 5 years at the MHRA Lewis had responsibility for the licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, managing and leading a team of GMP Inspectors, implementing changes to regulations and ways of working as a result of EU Exit, and supporting elements of the agency’s Covid-19 pandemic response. 

Prior to joining the MHRA Inspectorate Lewis spent 22 years working in the pharmaceutical industry in various QC, QA and management roles, and as a Qualified Person for a range of active pharmaceutical ingredients and non-sterile product dosage forms.

Lewis was trained and accredited by the MHRA to inspect:

• API manufacturers, importers and distributors  
• Importation of medicinal products 
• Non-Sterile manufacturing sites   
• Contract laboratories   
• Excipient manufacturers  
• Storage and distribution sites

He has expertise in MHRA and EU Inspection preparation and remediation, Pharmaceutical Quality Management Systems, and training in EU GMP Regulatory requirements and is eligible to act as an EU Qualified Person.

With his wide portfolio of experience, Lewis is a great addition to the core EPiC team and with his help we are confident we can extend our GXP support across the medicinal product lifecycle and help all our clients to improve their GXP quality systems and regulatory compliance.

If you need our help and support from an Ex MHRA Inspector then please contact us on +44 (0)1244 980544 or e mail us at enquiries@epic-auditors.com

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.

The Autumn Compliance Seminar had been given ‘In Principle’ CPD Certification

EPiC Auditors have received notification from the CPD Certification Service that the further learning value and structure of our Autumn Compliance Seminar on 10^th November 2022 conforms to CPD guidelines and we have been given ‘in principle’ certification for our forthcoming event.

Continuing professional development (CPD) is an important part of any business. It’s the intentional process of learning and improving your skills in order to keep up with changing technology, meet new industry standards, and prepare for future job roles or promotions.

CPD requirements are present in most professions and is particularly important in the pharmaceutical industry. Most companies and organisations now prioritise CPD because they ensure a constantly developing workforce. Depending on what kind of work you do and where your career is going, continuing professional development can range from participating in online course every few months or attending an industry conference every year.

It can be difficult to commit time to CPD and attend conferences when you are already busy with other tasks at work, so EPiC Auditors will bring a high quality, informative and thought provoking  seminar to you on Thursday 10^th November.

Our full day virtual conference will be delivered live, remotely online between 9.00 am and 5.00 pm (GMT) with interactive sessions and an opportunity to ask our expert panel those burning compliance questions!

We had some fantastic feedback from the attendees of our GMP Symposium 2022 in February 2022:

“Excellent symposium. Exceptionally knowledgeable presenters allowing an insight into the perspective of regulatory inspectors, this is invaluable information for those of us in industry. The platform was very impressive, and is easily the best example of an virtual meeting solution for large events I have encountered. Good breadth of topics covered across the day also, making it an excellent investment of time.”

“Really enjoyed today, very informative and the schedule was well put together covering lots of key points.”

“Well worth attending – a very valuable day”

“Excellent symposium! Expertly planned and delivered, I was not bored at all for the whole day”

“Really informative symposium with interesting contents and knowledgeable speakers. Highly satisfying.”

An application has been made to accredit the event and award CPD points. Certificates will be sent to the email address you have registered with approximately 2-3 weeks after the event.

If you haven’t already booked tickets for our Autumn event, head along to our registration and bookings page here to find out more: https://epic-auditors.com/epic-auditors-autumn-compliance-seminar/

“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: