MP-B Seminars

9:30 am - 9:50 am

Introduction to Pharmacovigilance

Roshan will provide a simplified overview of Pharmacovigilance (PV).  The presentation will cover a

background of PV, relevant laws and regulations, role of a QPPV and ultimately how PV plays an integral role in patient safety.

Speaker

9:50 am - 10:10 am

Primary Validation of a RMM For At-line Bioburden Analysis of Pharmaceutical Water

Flow through cytometry is a widely accepted technology for measurement of microbial contamination in laboratories. But it’s not common for in process control

This technology gives more than just a real number of organisms in a sample. It allows for more insight into the population.

Differentiation between living and dead cells, between high and low nucleic acid organisms and even some information about the population itself makes it a promising technology for water bioburden analysis.

The technology and the primary validation as the first step for the total validation procedure will be presented.

Speaker

10:10 am - 10:30 am

How to Overcome Challenges in the Formulation of ODT

Speaker

  • Shilpa Mistry Head of Pharma,UK and Ireland - Chemlink Specialities
10:30 am - 11:30 am

Break & Exhibition

11:30 am - 12:00 pm

The Revised IPEC Significant Change Guide for Pharmaceutical Excipients

Speaker

12:00 pm - 12:30 pm

EXCiPACT Pharmaceuticals Auxiliary Materials

Speaker

12:40 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

Advances in Disinfection Validation Aligned to Annex 1 Changes

Speaker

4:05 pm - 4:25 pm

Reducing Risk and Save Cost with New Surface Cleaning System

Speaker

4:25 pm - 4:45 pm

In-line UV-Vis Spectrophotometry for the Process Control of Pharmaceutical Cleaning, Batching and Manufacturing

Speaker

  • Luke Hulse MEng Chemical Engineering Final Year - University of Bath
9:15 am - 9:55 am

How to Effectively Manage a Remediation Programme

Speaker

  • Giby George MD, Senior Consultant and QP - GMP Healthcare
9:55 am - 10:15 am

Rapid Approval for Parallel Import Submissions

Speaker

  • David Guest Ex-MHRA Part-Time, Independent Consultant - Parallel Import Licencing
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

Amorphous Solid Dispersion Formulation and Compaction Process Optimization Using Quality by Design Principles and Tools

Speaker

2:20 pm - 2:40 pm

An Introduction to Particle Size Analysis Basics for Pharmaceutical Ingredients and Formulations

Speaker

2:40 pm - 3:00 pm

Emerging Technologies for Making Pharmaceuticals at the Point of Care

Speaker

  • Dr Dennis Doroumis Professor in Pharmaceutical Technology and Process Engineering - University of Greenwich
3:00 pm - 4:00 pm

Break & Exhibition