Room E Seminars

10:50 am - 11:30 am

Break

11:30 am - 11:50 am

GMP and GDP Training:  The Big Challenge – Demonstrating That Learning Has Taken Place

11:50 am - 12:10 pm

The Quality Management System

Speaker

12:10 pm - 12:30 pm

The Cost of Quality (CoQ), or Rather The Cost of Poor Quality

2:00 pm - 2:30 pm

Clinical Trial Readiness – Getting the Most Out Of Your Clinical Trial

As you embark on your clinical development journey, there are a number of vital planning considerations to be addressed that will impact the success of your clinical trial, whatever your product. Join us to learn more about how to prepare so that your trial is set up for success.

Speaker

3:00 pm - 3:45 pm

Break

9:15 am - 9:35 am

Engaging Management With Their Regulatory Obligations

9:35 am - 9:55 am

The Obligations Of The WDA Licence Holder

Speaker

9:55 am - 10:15 am

Organisational Culture, The Hidden Driver of Compliance

11:30 am - 12:30 pm

Good Distribution Practice and How The ECA / PQG Monographs Can Help You

Speaker

  • View full profile for Phil ButsonPhil Butson Director, R&D Quality Futures - Glaxo SmithKline
2:00 pm - 2:20 pm

Using Vacuum Evaporation to treat Pharmaceutical Wastewater

Speaker

  • View full profile for Kalpesh ShahKalpesh Shah Industrial Sales Manager - Veolia Water Technologies
2:20 pm - 2:40 pm

If APIs go wrong – managing delays, typical problems and quality claims

If you have never had a problem with an API it’s probably safe to say you just haven’t had a problem yet.

In this presentation we’ll take a look at some real-life examples of things that can go wrong and how you might prepare and mitigate:  shipment delays; service complaints; transit damage; insurance responsibilities; Quality claims; post-Brexit import issues etc.

Problems can be a black-hole of time to fix so it’s wise to be as forewarned as you can be!

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
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 be mitigated.

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 at possible scenarios for the future. Is the industry ready to truly embrace a risk-based approach to supply chain oversight? How can we use data and metrics to decide the allocation of resources most effectively for insightful audits? Are remote audits here to stay?

Speaker

3:20 pm - 4:00 pm

Break