Tableting Oily APIs
Speaker
Dr Gernot Warnke Head of R&D - JRS PHARMA
MP-C Seminars
9:30 am - 9:50 am
9:50 am - 10:10 am
Innovative Bi-phasic Stickpack Drug Delivery System for Dexamethasone with GalenIQ 960
Speaker
Dr Michael Black Head of Sales Pharma - Beneo Palatinit GmbH
10:10 am - 10:30 am
Highly Potent API Occupational H&S When Making Pharmaceuticals
Speaker
Justin Mason-Home Director/Owner - HPAPI Project Services Limited
10:30 am - 11:30 am
Break & Exhibition
11:30 am - 12:00 pm
Update to Manufacturing Classification System
Speaker
Dr Kendal Pitt Academy of Pharmaceutical Sciences
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
Prof Dr Bindhu Gururajan Senior Expert, Science and Technology - Novartis
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
Martin Lush Ex-VP - NSF International
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
Dr John Henderson Technical Communications Specialist - Britest Limited
4:05 pm - 4:25 pm
Cleaning – Switch from Solvents to Detergent Cleaning in API Manufacturing
Speaker
Thomas Altmann Technical Consultant & Validation Manager - Ecolab
4:25 pm - 4:45 pm
Auditing Annex 16 – Role and Influence of the QP on Audit Programme Design
Speaker
Peter Deegan RSSL Consultant Training Ambassador - RSSL
4:45 pm - 5:05 pm
How to Minimise False Positives During Sterility Testing
Speaker
Chris Berridge Ecolab Ltd
9:15 am - 9:35 am
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
Zhiru Tang Platforms Engineering Manager - GSK
10:15 am - 10:35 am
10:35 am - 11:30 am
Break & Exhibition
10:35 am - 10:55 am
Lite MES – A Case Study for Agile Digital Manufacturing
Speaker
Neil Wetherall Managing Director - Factorytalk Limited
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
Luca Marchesi Managing Director - PURE+ LTD
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
John Cobb GMP Microbiologist - PMT (GB) Ltd
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
John Chewins Scientific and Regulatory Director - Ecolab
3:00 pm - 4:00 pm
