Conference Room E Programme

26 April

9:30 am - 10:10 am

What are the Differences in Responsibilities Between a RP, QP & RPi?

Speaker

10:10 am - 10:30 am

The Cleaning Challenge with Pharma Excipients

APIs (Active Pharmaceutical Ingredients) and their solubility in water are often used as the rationale to identify the worst case product. According to Annex 15 (10.10) the criteria for determining the worst case may include solubility, cleanability, toxicity and potency. The cleanability of a product can also be driven by the excipients used. This presentation will identify excipients that can cause cleaning challenges (e.g. Carbomers, TiO2 and other pigments) and discuss ways to resolve the issues.

Speaker

10:30 am - 11:30 am

Break

11:30 am - 11:50 am

Digitalisation to Improve Knowledge Management

Speaker

12:10 pm - 12:30 pm

Process Vessel Temperature Control Systems (How to Reduce Operational Costs and Improve Controllability)

Speaker

12:30 pm - 2:00 pm

Break

2:00 pm - 3:00 pm

KEYNOTE in ROOM A: Pharma – Balancing Compliance and Charitable Efforts

A former MHRA inspector's experience showing different expectations of the UK Pharmaceutical industry. On the one hand, the licence holder has a desire to respond to humanitarian need. On the other hand, they meet many challenges and must still achieve compliance and exercise due diligence. Can we resolve this dilemma?  

Speaker

3:00 pm - 3:45 pm

Break

3:45 pm - 4:45 pm

Collaborative Innovation to Drive Progress- How Can Working With Others Speed up Your Innovation

Speaker

  • Dr Dave Berry Grand Challenge and Digital Strategy Lead - Centre for Process Innovation

27 April

9:15 am - 9:45 am

Common GMP Deficiencies

Speakers

9:45 am - 10:15 am

Common GDP Deficiencies

This session will be led by former MHRA GDP Inspectors and Operations Managers who will share some of the most common deficiencies and deviations from GDP requirements that are noted both on inspection and in the wider pharmaceutical wholesale industry.  They will highlight where potential compliance gaps can be found and suggest ways these can... Read more »

Speakers

10:15 am - 11:30 am

Break

11:30 am - 12:30 pm

Quality Risk Management in GDP

Speaker

  • Neil Wayman Secretary - Pharmaceutical Quality Group (PQG)

12:30 pm - 2:00 pm

Break

2:00 pm - 2:20 pm

Remote Audits – What Can We Learn From The Past Two Years to Develop Successful Strategies for the Future? David Waddington, NSF Health Sciences

The pandemic has challenged industry and regulators to adopt innovative approaches to traditional methods of auditing to ensure safe and continued supply of essential medicines. For the past two years on site audits have been largely replaced by ‘desktop’ or virtual audits. Drawing from his experience of over 150 remote audits, Dave Waddington will look... Read more »

Speaker

3:20 pm - 4:00 pm

Break