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Martyn Becker has
more than thirty three years' pharmaceutical experience and
expertise.
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Qualifications:
- BSc (Hons) Microbiology
- Chartered Biologist
- Member of the Institute of Biology
- Lead Assessor of ISO 9000 systems
- Board member for PDA (Parenteral Drug Association) UK chapter
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A microbiologist by training, he has spent twenty eight years in:
- Aseptic manufacturing of vaccines, both in production and its
management
- Internal GMP self-assessment (audit) and external audit, both in
actual audit and its management
- Laboratory operations
- Direction of Quality Assurance
- Aseptic, non-sterile and bulk manufacturing facility design
- Design and implementation of global aseptic control systems
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Five years were spent with the
UK MHRA as:
- Medicines Inspector
- Senior Inspector (specialising
in Aseptics, Steriles and Biologicals)
- Regional Manager
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Martyn
Becker has also served, and continues to serve in critical
regulatory liaison focus groups.
- Part of MHRA update team for EU GMP Annex 1 in 1996.
- Member of Product Quality Research Institute (PQRI) team that
worked with FDA on the 2004 re-publication of the FDA Aseptic
processing guidance.
- Member of EFPIA
(European Federation of Pharmaceutical Industries & Associations)
teams that provided industry input into the updates of Annex 1 in
2003 and 2007.
- Regularly
requested to present sessions at major industry group meetings:
- PDA annual
meeting, Orlando 2004.
- PDA
training meetings for FDA aseptic guidance, Europe 2004.
- DIA (Drug
Information Association) annual meeting, Barcelona 2006.
- PDA/FDA
joint regulatory conference, Washington September 2006.
- PDA/EMEA
joint regulatory conference, Budapest February 2008.
- PDA risk
management conference, Washington, May 2008.
- PDA/FDA
joint regulatory conference, Washington, September 2008.
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- Member of
organising team for joint PDA/PICS/ISPE workshop on
Quality Risk
Management, to take place in Geneva, November 2008.
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Martyn
Becker Associates Global GMP consultants aseptics and steriles specialist
GMP consultancy. Good Manufacturing Practice standards for the
pharmaceutical industry systems.