Job title: Director, Operation Quality, QA Audit and Compliance
Andrew was has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years. Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.
Prior to this Andrew was an Inspector with the MHRA for nearly 14 years. This role included:
- Routine (and less routine!) inspections across the world, including joint inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of technical areas including, sterile products, biological products, blood components and plasma.
- Chairperson of the Inspectorates Compliance Management Team (working with marginally compliant companies to support them back to full compliance)
- Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites)
- Inspector training and mentoring
- Taking part in the writing of regulatory guidance documents including:
- MHRAs Data Integrity guidance
- EMA guidance on water systems
- Chair for the working group for the revision of Annex 1
- MHRA blog regarding the fragility of VHP
- Supporting external industry bodies with technical monographs such as PDA TR1 and PHSS TM20.
Prior to joining the MHRA Andrew worked for more than 20 years in a number of different areas and technologies in the Pharmaceutical industry. These included QA, Validation and Production Management in both sterile and non-sterile manufacturing facilities.
Sterilization to Meet ANNEX1 & Pitfalls of VHP 2:15 pm
Finding a sterilising agent that reaches all the critical surfaces in a consistent and repeatable manner Preventing cross contamination in multi-product production plant Does single use always mean sterile?Read more
day: Day Two
Panel Discussion: How Can We Be More Proactive in Ensuring Safe HPAPI Handling? 9:15 am
How to align regulators’ expectations and standardize common approaches amongst API suppliers and drug manufacturers? Taking responsibilities in your own hand with zero accident tolerance – from culture to driving processes in place: the difficulty between doing this in-house and outsourcing Can OEL limits be unified across the industry?Read more
day: Day One