EPiC Auditors Autumn Compliance Seminar has been given ‘In Principle’ CPD Certification

CPD Certification

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 10th 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 10th 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/

Agenda Announced for the EPiC Autumn Compliance Seminar

EPiC Autumn Compliance Seminar

With just over 3 weeks to go until the EPiC Autumn Pharma Compliance Seminar on Thursday 10th November 2022 we have released a copy of the whole day’s agenda.

Here’s a summary of what is covered:

  • Guest speaker Richard Parker, Senior GMDP Inspector at the MHRA will be delivering an MHRA update on Annex 1 with a regulators view of the changes.
  • Richard Andrews (EPiC & ex MHRA GMP Inspector & Unit Manager) will be your host for the day as well as giving an overview of recent updates to guidance & regulations and how to future proof your compliance.
  • Michelle Yeomans (EPiC Operations Manager and ex MHRA GMDP Inspectorate Unit Manager) will be reviewing the direction of travel for compliance and speaking to Louise Mawer (ex MHRA Inspector) about the implementation of the Clinical Trials Regulation and overcoming challenges at the IMP/GCP interface.
  • Darren Jones (EPiC & ex MHRA Inspector) will explain how to develop your PQS and move from remediation to sustainable compliance, as well as discussing current and future Annex 1 deficiencies and the  the pitfall to avoid.
  • Liz Allanson (EPiC & ex MHRA GMP Inspector) will give a presentation on points to consider when moving from an R&D to a GMP environment.
  • Guest speakers Gaynor Brummitt (SeerPharma UK & ex MHRA Senior GDP Inspector) & Shahbaz Sarwar (SeerPharma UK ex MHRA GDP Inspector) will be explaining Importation and the Role of the RPi.       
  • There will also be a Q&A session where a panel drawn from the speakers will answer questions submitted throughout the event.

Download the Agenda here:

The day promises to be of real interest to pharmaceutical industry professionals involved in the manufacture and supply of medicines and aims 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. 

How to secure your place

Tickets are now available to buy online and cost £250.00 + VAT

Click on the button below to register

Any booking enquiries, please email: enquiries@epic-auditors.com


In collaboration with SeerPharma UK

You may also be interested in the SeerPharma UK GDP Symposium taking place on Tuesday 8th November 2022: Register and Pay Online Here

EPiC Top Tips-Calibration

5 Top Tips for Calibration Success

Article By Darren Jones, Director & Senior Consultant for EPiC Auditors Limited

calibration

Calibration is an often-overlooked area of the PQS; many calibration certificates are incorrect or don’t contain adequate detail and in many cases are not understood by the site experts!

Calibration services are frequently outsourced and I often find that key GMP decisions have also been inappropriately outsourced as well! Does the calibration company set the limits? Who determines how and when out of specification results are reported?

Many certificates do not state Pass or Fail… Why not? The certificates often just contain the limits and the data. I regularly find calibration results that do not comply with the limits- the calculations have not been done and no one in the Pharma company has checked the data!

Limits are sometime specified as +/-2% of FSD (full scale deflection). What does this mean? Often the method of calculating this is not clear and the calculations used to determine this limit are not recorded or checked.

Given accurate instrumentation is key to achieving process control, which ultimately assures product quality, calibration requirements need to be understood and properly managed.

Tips for success:

  1. Use multi-point calibration over the working range of the instrument.
  2. Ensure you set, or at least approve the limits applied during calibration, don’t leave this just to the contractor.
  3. Have a contract with the provider that includes instruments, frequency, limits, ranges and out of specification results reporting. Appendices containing tables can be useful to manage the detailed information.
  4. Ensure results are reported as found and as left, i.e. pre and post any adjustment, you don’t want to miss a failed as found result.
  5. Ensure limits are clearly understood. The SOP should show how to calculate limits e.g. based on FSD and these calculations should be documented and checked as per any other important calculation.  Evaluate the limits using Pass/Fail criteria.

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

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 Inspection Action Group 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.

iag

REMOTE PHARMACEUTICAL AUDITS AND SUPPORT

During the Covid 19 pandemic, like the MHRA, and like many other businesses, EPIC Auditors has been providing remote pharmaceutical audits and support.  Helping companies to meet the regulatory requirements and to develop the quality systems essential to support much needed clinical trials for various Covid 19 treatments.  

As part of this facilitation work, EPIC have developed a set of generic SOPs for key elements of the quality system that companies can then adapt to their own business framework and style. We now have a set of 10 SOPs covering:-

  • Quality Management Reviews
  • Deviations
  • CAPA
  • Complaints
  • Recall
  • Change Control
  • Quality Risk Management
  • Documentation
  • Self – Inspection
  • Supplier Evaluation

You can purchase this set of SOPs for £2700 by contacting:   enquiries@epic-auditors.com

We also have a  set of SOPs specifically for manufacturers of IMPs covering:

  • Importation of IMPs
  • Batch Certification
  • Reference & Retained samples for IMPs
  • Complaints
  • Recall

Please let us know if you are interested in remote audits and support, using the same e mail address.

In addition to providing support for Covid trials, we have also adapted to providing routine remote pharmaceutical audits of all kinds including internal audits and supplier audits as well as mock MHRA inspections. Advances in technology are helping us to overcome the challenges of remote auditing but it is likely that the efforts will not be wasted, as remote auditing is probably going to be with us for some years to come.

If you need our help and support then please contact us on  +44 (0)1244  980544

or email us at:  enquiries@epic-auditors.com