MP-C Seminars

9:30 am - 9:50 am

Tableting Oily APIs

Speaker

9:50 am - 10:10 am

Innovative Bi-phasic Stickpack Drug Delivery System for Dexamethasone with GalenIQ 960

Speaker

10:10 am - 10:30 am

Highly Potent API Occupational H&S When Making Pharmaceuticals

Speaker

10:30 am - 11:30 am

Break & Exhibition

11:30 am - 12:00 pm

Update to Manufacturing Classification System

Speaker

12:00 pm - 12:30 pm

Formulation Science and Process Engineering for Drug Product Development

Drug product development involves various activities such as drug substance characterization, excipient selection, formulation development, process identification, process development, scale up, process robustness, technology transfer, process validation, regulatory submission and commercialization. All these steps involve fundamental science and Process Engineering application. Lot of techniques have been developed for material characterization and recently tools have been developed for process modelling for critical unit operations.

In this presentation, case studies will be presented to highlight the key principles related to formulation development and application of first principles approach for process development. Drug development activities related to late phase product development and some of the troubleshooting for critical process and formulation issues will be discussed.

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

ETERNAL – A New Collaboration to Establish Safe and Sustainable Pharmaceutical Lifecycles by Design

Speaker

4:05 pm - 4:25 pm

Cleaning – Switch from Solvents to Detergent Cleaning in API Manufacturing

Speaker

4:25 pm - 4:45 pm

Auditing Annex 16 – Role and Influence of the QP on Audit Programme Design

Speaker

4:45 pm - 5:05 pm

How to Minimise False Positives During Sterility Testing

Speaker

9:15 am - 9:35 am

Safety Considerations in Manufacturing Pharmaceuticals

Speaker

9:35 am - 9:55 am

Pharmaceutical Supplier Qualification

Speaker

  • Richard Coe GDP Responsible Person - Protogen Consulting
9:55 am - 10:15 am

Engineers’ Role in Managing Third Party Engineering Service Contracts

Speaker

10:15 am - 10:35 am

Electronic Work Instructions – A Use Case for Digitalisation Technology

Speaker

10:35 am - 11:30 am

Break & Exhibition

10:35 am - 10:55 am

Lite MES – A Case Study for Agile Digital Manufacturing

Speaker

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

Bio-decontamination Procedures According to the Latest ANNEX – Use of VHP Generators

Speaker

2:20 pm - 2:40 pm

Trends in Microbial Monitoring of Air in Aseptic Manufacturing

Assuring successful aseptic manufacturing of sterile requires an understanding of the difficulties and limitations of test methods employed.
Various current methods are discussed as to their strengths and weaknesses.

Speaker

2:40 pm - 3:00 pm

Understanding Regulations – Examining the Impact of the Biocidal Products Regulation (BPR) on Automated Airborne Disinfection Systems and Their Use in Aseptic Processing Facilities

Speaker

3:00 pm - 4:00 pm

Break & Exhibition