The PQG evening virtual event for Trainee QPs, titled “Overview on Stability Studies Requirements and Handling Unexpected Stability Events,” took place on February 25th via Zoom, utilizing its breakout rooms feature to facilitate effective discussions.
Mick Stuart (Contract QP and RP/RPi) delivered a focused presentation covering the purpose of stability studies, the QP Study Guide requirements, essential QP considerations, and relevant ICH and other guidelines. He also provided a summary of regulatory findings and recalls associated with stability issues.
Following the presentation, attendees were divided into 8 small virtual groups to engage in Viva-type practice questions, simulating how to manage unexpected stability events. The high level of participation allowed attendees to discuss the impacts of stability events, elaborate action plans, and articulate their responses effectively.
As always, the presentation is available in the members area of the PQG website.
A heartfelt thank you to Mick Stuart and the PQG committee members for organizing this event, and special thanks to the attendees for their active participation and positive feedback.
On March 3rd, the Pharmaceutical Quality Group (PQG) held a highly successful virtual training event targeted at Qualified Persons (QPs), Trainee QPs, and their Sponsors. The event “Trainee QP, Sponsors, and QP CPD virtual event”, featured a lineup of expert speakers and interactive sessions designed to support the professional development of all participants.
The event commenced with a comprehensive presentation on Pharmaceutical Regulatory and Legislative updates by Pete Gough, NSF Vice President. Pete’s presentation, as expected, was a phenomenal source of information, providing valuable insights for those training to become a QP and also for experienced Quality Professionals.
Following this, David Moulding, Registration Standards Specialist at the RSC, delivered an overview of the application process for QP Eligibility. David’s session covered key aspects such as the “registration step” to confirm eligibility criteria, knowledge and experience requirements, and the viva process, offering attendees a thorough understanding of what is required to become a QP.
Utilizing Zoom’s breakout rooms functionality, attendees were divided into six small virtual groups to practice viva-type questions. This interactive segment provided a fantastic opportunity for participants to discuss various scenarios, share their experiences, and verbalize their answers, fostering a collaborative learning environment.
PQG thanks all the speakers, facilitators, and attendees for their active participation. The extremely positive feedback received will help us shape future virtual events, ensuring they continue to meet the needs of QPs and Trainee QPs in their professional development journeys.
The PQG and CQI Audit SIG held a very well-attended joint webinar on Self-inspections on February 11th, 2025, presented by Phil Butson and Richard Brett.
Phil looked at the GMP and GDP requirements for self-inspections and provided some pointers for practical implementation relating to the Programme, Personnel, Reports and CAPA. He highlighted the importance of a risk-based approach and how this enabled the principles to be scaled to fit the business.
Richard drew from his many years of experience to provide A Corporate Risk Perspective, including the Three Lines of Defence model and Risk Management, including the PESTLE model and Johari Window. He noted that when it comes to Quality, Corporate auditors are looking at the Quality of the Management more than the Management of Quality.
There was great engagement from attendees in the form of numerous questions and comments. This enabled a deeper look at the expectations of regulatory authorities, the challenges of small organisations and the importance of culture, to mention just three topics. There were also interesting comments about how the Three Lines of Defence model is used in other industries too.
The slides from the webinar are now available in the PQG members’ area here (PQG members only)
A recording of the webinar is available in the CQI Quality Learning Hub (free to CQI members; £10 for others).
The PQG Pharmaceutical Auditing monograph is available to buy in both paper and electronic formats from the PQG Shop
Keep an eye out for emails about future events, or take a look at the Events page
Celebrate excellence in Quality and #WQW24 (between 11-15 November) with us and help raise awareness of the quality management profession globally.
World Quality Week 2024 is your opportunity to celebrate your quality achievements, raise awareness of the quality management profession and focus on realising your competitive potential.
Quality: from Compliance to Performance.
CQI has created #WQW24 resources to help you gain recognition for the great work that you do every day.
For more details, follow the link.
The PQG and QPQuandary’s evening virtual event “Leadership aspects of being a QP – going beyond the comfort zone” was held on September 19th.
Alex Hall and Tanya Agombar (QPQuandary) gave an overview of the difference between Leadership and Management and highlighted the benefits of being a good leader.
Every participant had fun discovering their “leadership style”; understood why QPs have typically more than one style and how to adopt a different style based on the situation they are dealing with.
Many thanks to Alex, Tanya (QPQ) and Romina, Sarah (PQG) who organised this event. Also special thanks to all the participants for sharing their experience and for the high level of engagement.
Looking forward to seeing you at our next events
Another successful PQG evening virtual event for Trainee QPs was held on June 26th using Zoom and its breakout rooms functionality to enable effective discussions.
Mick Stuart (Contract QP and RP/RPi) presented an Overview on Annex 16, including QP Roles & Responsibilities” promoting an interesting and engaging Q&A session – especially on sampling and testing upon importation and the current and future supply requirements for Northern Ireland.
The trainee QPs were then split into 8 small virtual groups to practice Viva type questions based on complex supply chains. Everyone had the opportunity to practice their thought processes, share their experiences, discuss actions, agree next steps and verbalise their answers.
As usual, presentations are available on the PQG website members area.
Many thanks to Mick and the PQG committee members who organised this event. Also special thanks to the attendees for their engagement and positive feedback.
The PQG and QPQuandary’s evening virtual event “Being a great QP Sponsor” was held on May
30th. This was the first event specifically aimed at QPs acting as a Sponsor for a trainee QP or
considering becoming a Sponsor.
Alex Hall and Tanya Agombar (QPQuandary) gave an overview of the process and based on their
extensive experience, shared extremely useful advice on how to: plan for success, give constructive feedback and prepare the trainee for the assessment.
Every participant actively interacted during the event: we all shared the challenges in fitting the
Sponsor role with our day-to-day work, but we unanimously agreed how the reward in sponsoring a future QP is worth all the efforts.
Many thanks to Alex, Tanya (QPQ) and Mick Stuart, Romina, Sarah (PQG) who organised this event.
Also special thanks to all the participants for their positive feedback and high level of engagement.
Looking forward to seeing you at our next events:
PQG has just completed a well-received series of three webinars on Auditing in Pharma jointly with the CQI Audit SIG.
The three sessions were:
The slide decks are available to all members in the Members Only area of the website (log in first to access).
Thanks to Dave Waddington, Richard Brett and Phil Butson for hosting/presenting at these webinars and to all those who attended and participated in the discussions.
If you have any suggestions for topics of similar sessions in future, or wish to be involved in making them happen, then please email Dave at chairman@pqg.org
Want to learn more about auditing?
Treat yourself to a copy of the Pharmaceutical Auditing monograph from the PQG shop (log in first to obtain the members’ discount price).
The quality of medicinal products results from the sum of many activities. End product testing alone is not sufficient to ensure product quality; an overall pharmaceutical quality system is required that builds in the quality. Quality auditing is a key management tool for monitoring and evaluating compliance and the delivery of the pharmaceutical quality system objectives, for driving continual improvement as well as assuring patient safety.
The PQG Pharmaceutical Auditing monograph has been extensively revised and expanded to reflect current regulatory requirements and changes in audit practices arising from developments in information and communications technology and Covid-19 pandemic experiences.
Given that the outcome of an audit depends on both the auditor and auditee, this monograph seeks to equip auditees in addition to being a valuable tool for auditors. It also covers audit programme management.
The new monograph is available in both printed (A5 wire bound) and electronic (interactive .PDF) versions. Whichever format you prefer, purchase your copy now from the PQG Shop. PQG members receive a 20% discount on the base price, so (join first if you need to and) remember to log in as a member before making your purchase.
For optimal functionality it is best to use a PDF Reader for the interactive version, but it also works in a web browser.
On October 10th the PQG hosted the Trainee QP, Sponsor and QP” virtual event using the
“Zoom” platform.
This regular event started with the overview of the application process for QP Eligibility, covering
key aspects such as the “registration step” to confirm eligibility criteria, knowledge/experience
requirements and the viva process, by David Moulding (Registration Standards Specialist, RSC).
Attendees were split in small virtual groups to practice Viva type questions. This was a great
opportunity for trainees to discuss several scenarios, share experience and verbalise answers.
Many thanks to the speakers, facilitators and attendees. The extremely positive feedback
received will help us to shape future virtual events.
Look at our PQG web page: The Pharmaceutical Quality Group (pqg.org)/events for future PQG Events.