| |
Martyn Becker has
more than thirty three years' pharmaceutical experience and
expertise.
Please click
here to view a full curriculum vitae as a PDF. You will
need the free Adobe viewer which you may already have installed on
your computer, or you can obtain it at
adobe.com. |
Qualifications:
- BSc (Hons) Microbiology
- Chartered Biologist
- Member of the Institute of Biology
- Lead Assessor of ISO 9001 systems
- Board member for PDA (Parenteral Drug Association) UK chapter
|
A microbiologist by training, he has spent
thirty years in:
- Aseptic manufacturing of vaccines, both in production and its
management
- Internal GMP self-inspection 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
|
Five years were spent with the
UK MHRA as:
- Medicines Inspector
(all dosage forms)
- Senior Inspector (specialising
in Aseptics, Steriles and Biologicals)
- Regional Manager
|
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 FL, 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 annual
meeting, Colorado Springs CO, April 2008
- PDA risk
management conference, Washington DC, May 2008.
- PDA/FDA
joint regulatory conference, Washington DC, September 2008.
- PharMIG
conference, Nottingham, England, November 2008.
- PDA/PICS/ISPE
conference (Quality Risk Management), Geneva, Switzerland,
November 2008
- PDA annual
meeting, Las Vegas NV, April 2009.
- PharMIG
conference, Cork, Ireland, May 2009.
- PDA/FDA
joint regulatory conference, Washington DC, September 2009.
- PDA/EMEA
joint regulatory conference, Berlin, Germany, October 2009.
|
- Member of
organising committees for
- PDA/FDA joint
regulatory conference (Washington DC, September 2009).
- PDA/EMEA joint
regulatory conference (Berlin, October 2009).
|
| |
| |
|
|
Martyn
Becker Associates Global GxP consultants specialising in aseptics and steriles. Good Practice standards
and systems for the pharmaceutical industry.