MP-A Seminars

9:30 am - 9:50 am

Successfully Overcoming Challenges to Supply Chain Oversight, Including GMP Audits in a Post Pandemic Environment

David will look at the difficulties being faced by manufacturers and auditors in conducting audits in the post pandemic world. Drawing on his extensive experience of auditing facilities around the world and virtually, he will look at how difficulties and challenges can be overcome to bring about a successful audit for both parties.

Speaker

9:50 am - 10:10 am

Environmental Monitoring System approaches for Isolator and Filling Line Systems

Aseptic isolators are commonly used in the pharmaceutical and life science industries in many applications, including filling lines, cell therapy processes, and sterility testing. This paper will outline some of the options and requirements that need to be considered when integrating an environmental or facility monitoring system (EMS or FMS) into these areas. It will discuss both viable and non-viable monitoring, and cover many of the aspects that need to be reviewed when producing a URS for such a system.

Speaker

10:10 am - 10:40 am

The Importance of Trade Associations – A Research & Development Perspective

Speaker

  • Karen Harvey Membership Manager - Chemical Business Association
10:30 am - 11:30 am

Break & Exhibition

11:30 am - 11:50 am

Understanding CPV (Continued/Continuous Process Verification)

Speaker

  • Bob Hayes Vice-Chair, Pharmaceuticals Technical Activities Committee - Institution of Mechanical Engineers
11:50 am - 12:10 pm

Engineering Processes – From Lab Bench to GMP Manufacturing

Speaker

12:10 pm - 12:30 pm

Climate Change Challenges

Speaker

12:30 pm - 2:00 pm

Break & Exhibition

2:00 pm - 3:00 pm

KEYNOTE ROOM A: The Agile Quality System: Doing More with Less – Faster

Speaker

3:00 pm - 3:45 pm

Break & Exhibition

3:45 pm - 4:05 pm

Reimagining Hard Shell Capsules – Liquid Filling for Enhancing Drug Delivery and Combination Products

Speaker

  • Dr Simon Roberts Scientific Business Development Manager Europe - ACG Europe Ltd
4:05 pm - 4:25 pm

New Insights into the influence of Pharmacel® MCC Grades on Tablet Compression Behaviour and Quality

Speaker

4:25 pm - 4:45 pm

Formulation of Mucoadhesive Dosage Forms: Materials, Approaches and Applications

Speaker

9:15 am - 9:45 am

IPEC Excipient Information Package and the New Sustainability Chapter

Speaker

9:45 am - 10:15 am

The Role of Excipients in Determining N-Nitrosamine Risks for Drug Products

Speaker

10:15 am - 11:30 am

Break & Exhibition

11:30 am - 12:30 pm

KEYNOTE ROOM A: Making a Covid 19 Vaccine During a Pandemic – A QP’s Perspective

Richard Tarrant was responsible for the final QP certification of the first batch of COVID-19 vaccine to enter clinical trials in Europe, the Oxford-AstraZeneca vaccine, and provided various support in efforts relating to material supply for clinical trials and emergency use authorisation.  In this talk, Richard will discuss the role of a clinical trial QP and how the small team at the Clinical BioManufacturing Facility (CBF) in Oxford were able manufacture, QP certify and release clinical trial material so rapidly and the various challenges encountered up until the point of emergency use authorisation.

Speaker

  • Richard Tarrant Contract Consultant & Qualified Person (QP) - RTMP Consultancy Ltd
12:30 pm - 2:00 pm

Break & Exhibition

2:00 pm - 2:20 pm

Applying for a Wholesale Distribution Authorisation (WDA(H))

Presentation looks at exploring the benefits and requirements of holding a pharmaceutical wholesale licence, giving an overview of basic requirements to get set up and maintaining a wholesale licence alongside other business activities.

Speakers

2:20 pm - 2:40 pm

How to Achieve Sustainable GDP Compliance

Speaker

  • Mark King Associate Director, Quality (QP, RP, RPi) - JensonR+ Ltd
2:40 pm - 3:00 pm

Effective Training in the Pharmaceutical Industry

An overview of the regulatory requirements for training. GMP and GDP expectations with regards to training. How these requirements can be achieved in practice. Evaluation of an individual’s training needs – what they know already and what they need to be trained in. How to evaluate training and its effectiveness. Different learning styles and catering for these in training sessions.

Speaker

3:00 pm - 4:00 pm

Break & Exhibition