EPiC Virtual Symposium 2024

EPiC proudly presents our full-day virtual symposium event featuring an esteemed lineup of former MHRA Inspector speakers.

📅Join us on Thursday, 28th November 2024, for our event;

FROM COMPLAINT TO COMPLIANT: A PRACTICAL GUIDE TO OVERCOME CURRENT GMDP CHALLENGES. 💊💊

We will explore the latest regulatory updates and guidance and provide practical guidance to conquer compliance challenges facing the pharmaceutical sector.

Our objective is to combine valuable insights using real-world examples and experiences from across our consortium of expert pharmaceutical consultants to provide the knowledge and offer practical solutions to overcome current GMDP compliance challenges.

For more information and to buy your ticket click on the link below;

EPiC Auditors Virtual Symposium 2024: From Complaint to Compliant: A Practical Guide to Overcoming Current GMDP Challenges

Join us for EPiC’s fourth annual virtual symposium on Thursday, 28th November 2024, titled “From Complaint to Compliant: A Practical Guide to Overcoming Current GMDP Challenges.”

Building on the success of our past symposia, this event promises a day packed with enlightening presentations by a distinguished panel of former MHRA Inspectors. We’ll explore the latest updates and guidance and provide practical guidance to conquer compliance challenges facing the pharmaceutical sector.  Further details can be found here; https://academy.epic-auditors.com/

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Pharma Discovery to Distribution

The EPiC team were pleased to be able to attend the UK’s Making Pharmaceuticals Conference 2024 in Coventry from 23rd to 24th April 2024.

The two-day conference covered topics spanning the entire product lifecycle, from discovery to distribution, and it was a fantastic opportunity to explain and promote our services to the conference attendees as well as meet with many of our current and past clients

“Keep Calm and Be Prepared” – Inspection Readiness Top Tips

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

Judging by the number of enquiries we are receiving to provide ex MHRA Inspectors to assist with inspection readiness preparations or remediation activities; it certainly looks like the number of regulatory inspections and supplier due diligence audits are returning to pre-pandemic levels.

Inspections are an opportunity to demonstrate compliance, so when you receive notification of a regulatory inspection (or external audit), keep calm, and use our top tips to help be prepared:

1. Inspection Scope  – Make sure that the purpose and scope of the inspection are clearly understood to help identify the relevant people, products, premises, systems, processes, and procedures that are likely to be involved so that these can all be factored into an inspection readiness plan. As part of the plan, consider the need for inspection awareness training for staff likely to be directly involved, especially if they have not previously experienced a regulatory inspection. Do not forget to check any contractual agreements, as contract acceptors may be required to notify the contract giver of any regulatory inspections.  

2. Compliance Status – Leverage output from the pharmaceutical quality system by referring to performance and trend data from self-inspections, deviations and CAPA, risk assessments, management review, etc. to understand how the quality system and operational processes are performing. This will either give you assurance that you are inspection ready or help identify specific compliance concerns or weakness to enable you to focus on implementing mitigating actions.  

3. Front and Back Room Organisation – Based on the scope and purpose of the inspection, identify and assign appropriate numbers of personnel (including deputies) to act as hosts, tour guides, scribes, runners, back-room staff handling document requests, and subject matter expects (SMEs). Provide some basic inspection preparation awareness training to give an overview of the inspection process and ensure everyone involved has a clearly defined role and purpose. 

4. Turning Negatives into Positives – In completing your inspection readiness plan you may have identified potential deficiencies or there may be questions you would not want an inspector to ask. Encourage the SME’s who know the areas of weakness to practice explaining in a clear and succinct way what the issues are and what is being done to improve the situation. Being able to clearly explain the issues, mitigating actions and CAPA already in place can help to reassure the inspector that a situation is under control and may avoid or reduce the severity of a deficiency.    

5. First Impressions Count – Get the inspection off to a positive start by anticipating likely questions and areas of interest and have documentation and premises ready for inspection.  Prepare a brief presentation covering site activities and confirm any significant changes since the previous inspection (if it is not the first inspection). Check that previous inspection actions have been closed and have evidence of closure to hand. Identify and walk the physical inspection routes and tidy the areas focusing on housekeeping and first impressions. Plan to walk the expected route each day to check on housekeeping, as new deliveries may have arrived, new production batches set up, new teams on shift, etc.   

By following these tips, you can prepare for an inspection by using practice runs and role-play scenarios to practice hosting, tracking, and responding to questions (including the difficult ones!) and help build confidence in being able to demonstrate compliance. 

Get in touch if you want to know more about our mock inspections or bespoke inspection readiness training.  

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

 You may also like to read our Case Study 1: Inspection Readiness: https://epic-auditors.com/case-study-inspection-readiness/

EPiC can now reveal our full agenda for our Virtual GMDP Compliance Symposium,  Beyond the Basics: Mastering GMDP Compliance and Inspection Readiness, taking place on Tuesday 5th December 2023.

Agenda Overview:

• Recent Updates to Guidance & Regulations
• How do you know you are Inspection Ready?
• Deficiency Data-Interpretation & Root Cause Analysis
• Innovation and ATMP Panel Discussion
• Annex 1 – Contamination Control Strategy (CCS) / Gap Assessments – Workshop
• ICH Q9 (new revision) – Risk Assessment
• GDP Masterclass – challenges faced by RPis, The Windsor Framework update, GDP inspection approaches
• Q&A Panel Session

Download the full agenda here:

Please take note that our schedules are subject to changes, depending on the situation at the discretion of the organisers.

🔍Meet the Experts🔎

Our carefully selected speakers bring a wealth of industry knowledge, having served as MHRA Inspectors. Their expertise and insights will provide you with invaluable guidance in navigating the complex landscape of regulatory compliance.

Discover how our expertise can take you beyond the ‘basics’ and propel your organisation towards excellence in pharmaceutical manufacturing and compliance!

Click here to read more about our speakers!

Not available on the day? We understand your schedule may not allow you to attend all the sessions of the event. A recording of the event will remain open 24/7 for 30 days. You can access the presentations whenever it’s convenient for you during this time.

Have a question? Need to register multiple people or pay offline?

Please email enquiries@epic-auditors.co.uk

We hope to see you there!