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!

The European Forum for Good Clinical Practice (EFGCP) are hosting a half day seminar this autumn on regulatory and ethical hot topics including practical considerations for ICH GCP E6(R3) Renovation, Investigational Medicinal Product (IMP) Regulations (EU and UK IMP considerations for compliance), an update from the MHRA GCP Inspectorate and ethical discussions on consent modernisation.

EPiC Auditors are pleased to support the event hosted by the Quality Working Party. Pharma compliance expert Michelle Yeomans will be delivering a presentation on the Clinical Trials Regulation transition and the implications for IMP management to ensure compliance. We believe in the importance of collaboration and knowledge exchange in the field of clinical trials to improve and protect public health.

The virtual seminar takes place on Monday, September 11th, 2023, and brings together leading experts and stakeholders to discuss practical considerations, updates, and ethical debates that are at the forefront of the industry.

To see the full agenda and register please visit the EFGCP Website.

Measuring Success – Top Tips for Assessing the Effectiveness of Training

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

The Covid-19 pandemic led to changes in the amount and delivery method used by Pharmaceutical companies to conduct training. Some companies cut back on training to conserve resources for core functions, whilst others invested in virtual training and e-learning to provide continued development opportunities for their employees. The situation was no different for regulators.

During the pandemic, I was the Unit Manager of the GMP and GDP Inspectorate at the MHRA, and as well as developing remote inspection approaches to ensure a continued level of regulatory oversight, MHRA used the opportunity to dedicate Inspectorate resource to enhance the range of training materials available within the ‘Inspector Academy’ knowledge hub and developed virtual training modules and competency frameworks. At the time, it was a case of adapting to the situation and being innovative in exploring available tools and techniques to identify the “least worst” available option.

Post pandemic, several conferences and training events have now returned to being run as face-to-face events, while others are continuing to offer virtual or hybrid options to maximise accessibility and minimise costs. EU GMP Chapter 2, 2.11 refers to the need for “continuing training” to be given and for its “practical effectiveness” to be periodically assessed. Continuing training is an ongoing process of learning and acquiring new skills and knowledge to help individuals stay updated with the latest developments and changes relevant to their role and industry sector. Continuing training can include self-learning so is not just limited to attending workshops, seminars, conferences, or specialist courses. The key point is finding a way to stay current with industry trends, which will help increase expertise and proficiency and support compliance with GMP requirements. Another key consideration is the need to keep a record to document the training, as training records are routinely reviewed during a regulatory inspection and provide evidence of continuing professional development.

With different training opportunities and formats on offer, it is important to have clearly defined learning objectives and ways of collecting information to determine whether the training provided has produced the desired effect and contributed to the development of the trainee.

Here are our top tips for assessing the practical effectiveness of training:

1. Pre and post-assessments: Conducting assessments, questionnaires, or quizzes before and after the training can help measure the knowledge, skills, or behaviour changes that have occurred as a result of the training. Comparing the scores or performance levels before and after the training provides an indication of the impact of the training.
2. Observations and simulations: Observing participants during or after the training session can help assess their application of the newly acquired knowledge and skills. This can be done through simulations or real-world scenarios to evaluate their ability to transfer the learning into practical situations.
3. Follow-up assessments: Conducting assessments weeks or months after the training has taken place can help evaluate the long-term impact and effectiveness of the training. This can provide insights into whether the learning has been retained, and if it has influenced the individual’s work performance over time.
4. Feedback: Soliciting feedback from trainees and supervisors or managers who work closely with the individuals can provide an additional perspective on the effectiveness of the training. They can assess whether the training has positively impacted the individuals’ job performance, productivity, or overall contribution to the organisation.
5. Performance metrics: Comparing PQS performance, KPIs or Quality metrics before and after the training can yield insights into any improvements or changes in the workplace performance of individuals or teams who participated in the training. An overview of GMP related training completed, and a review of PQS performance to identify compliance improvement topics for inclusion in further GMP refresher training should be included as agenda items at periodic Management Review meetings.

By using a combination of these assessment methods, organisations can gain a comprehensive understanding of the effectiveness of their training efforts and identify areas for improvement.

Please get in touch if you want to know more about our virtual symposia and bespoke in-house training courses.

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

 “Mind the Gap” – 5 Top Tips for Improved Self-Inspection

Article By Michelle Yeomans, Operations Manager for EPiC Auditors

During our time as MHRA Inspectors and now as pharmaceutical consultants, at EPiC we routinely see non-compliant sites i.e., those referred to MHRA’s Inspection Action Group (IAG) with a series of self-inspection reports indicating a high level of compliance. This begs the question why do some self-inspection programmes fail to adequately appraise the effectiveness and applicability of pharmaceutical quality systems (PQS)? 

Here are our top tips on how to avoid gaps between self-inspection and regulators findings: 

1. Remember why you are performing self-inspections Self-inspections are often not taken as seriously as regulatory inspections, but ultimately have the same objective to protect patients and product quality. Self-inspections can help identify and address deficiencies to support maintaining an “inspection ready” status by providing confidence that you as a licence holder are meeting your legal obligations to comply with EU GMP and GDP requirements.   

2. Self-inspection perception – Unless sufficient time and resources are allocated to self-inspection, programmes can become too informal and rushed. Taking the time to objectively evaluate a process, facility, or document should be seen as value adding by providing an opportunity to gather information about compliance and is a way for Senior management including QPs/RPs to have oversight of the performance of all areas of the business.​ 

3. Self-inspection focus – Consider whether audits should be horizontal audits i.e., follow the process flow from goods receipt to product release for example or be focussed on just one area of the process.​ Use a risk-based approach by researching the most common deficiencies found during inspections and audits e.g., consider examples which are published by MHRA, or featured in EPiC Seminar presentations, to ensure “hot topics” are include as an area of focus during the audit. Identify the high-risk areas of the process which will require more of your attention. This can be done by looking at the past performance of the area – deviations, change controls, previous audit findings etc​. 

4. Invest in Auditor training – Audits drive big decisions such as capex, awarding contracts, supplier approval, compliance level assessment, etc. so it is important auditors are trained. This includes having an understanding and ability to apply a broad range of softer behavioural and questioning skills, follow good practice guidance on the principles of auditing, and can demonstrate an understanding of the applicable GXP rules and regulations. 

5. Post audit activity – It’s not all about performing the audit, it is equally important to maintain a focus on CAPA completion and ongoing effectiveness checks. Successful completion of CAPA is integral to achieving the objective to protect patient and product quality and drives sustainable compliance. 

By following these 5 tips, you can improve the effectiveness of self-inspections, ensure that the PQS is continuously improving and “mind the gap” between self-inspection and regulatory findings! 

Get in touch if you want to know more about our bespoke inhouse training course on effective and value adding self-inspection and how we train auditors.  

Call to speak to one of our pharmaceutical consultants: +44 (0)1244 980544 or email us at enquiries@epic-auditors.com

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/