Company: MHRA (until Oct. 2020)
Job title: Lead Senior GMP Inspector
Graeme will start as an independent GMP consultant in October 2020 having currently been with the MHRA GMP inspection group since 2005. Graeme is a Lead Senior GMDP Inspector within the Inspection Enforcement and Standards Division at MHRA performing inspections across a wide range of pharmaceutical manufacturing and import activities in the UK and overseas.
Graeme led the EU Implementation team for Health Based Exposure Limits (HBEL) and chapters 3 & 5 updates, resulting in issue of a Q&A document issued via the European Medicines Agency (EMA) as well as training of EU GMP inspectors in 2018.
Graeme also led the PIC/S Working Group and Expert Circle Co-ordinating Committee on Control of Cross Contamination in Shared facilities (CCCISF). The group issued Aide-Memoires for Inspectors on inspection of cross contamination and Health Based Exposure Limits in 2019 and 2020. Graeme specified technical content, chaired and presented at the inaugural PIC/S Expert Circle on CCCISF in Taiwan in June 2019.
Graeme led the MHRA Cross Contamination Technical Sub-Group and was the GMP Inspectorate lead on the MHRA Inspection Action Group (IAG), a multidisciplinary group administering the regulatory action process on behalf of the UK Licensing Authority. Graeme also led for the inspectorate Compliance Management Team (CMT) an Inspectorate based senior inspection group managing sites with poor inspection performance with a goal to prevent the need for regulatory action.
Graeme is a Chemist and before joining MHRA he worked in the Active Pharmaceutical Ingredient industry for 13 years with GSK in a variety of Quality Assurance management roles and the Medical Device industry with Ethicon Ltd (a J&J company) for 12 years in Quality Control and management roles.
In an Increasingly Toxic Landscape, How is Regulation adapting to address this? 8:45 am
Recent history of PIC/S and regulatory developments on cross contamination control Regulatory insight on establishing and utilizing health based exposure limits Expectation of PIC/S on technical and organizational controls for facilities & equipment: CGMP requirements for highly potent and toxic compounds With an increase in offshore outsourcing, what are the key regulatory differences across the…Read more
day: Day One
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