Gerry Burke

Home / Our Tutors / Gerry Burke

Gerry is a self-motivated medical industry professional with knowledge and experience of remediation in the highly regulated medical device, pharmaceutical and biotechnology markets, in particular sterile products. Skilled in developing and implementing strategic remediation plans, for example those aimed at DHF completion and CAPA compliance, including completion of verification, validation and effectiveness actions. Gerry has an excellent track record in Quality Systems, Validation and Risk Management projects in Medical Industry projects. Recent projects have included; Design History File remediation, Risk Management according to ISO 14971, preparation and updating of pFMEA, dFMEA, Risk management Plans, Risk management reports, and change control optimisation for deviations. Gerry implements a hands on approach to problem solving, project development and remediation activities.

Student Testimonials

Tutor Quote

“Very good course….enjoyed day two getting into actually performing an audit to MDSAP requirements. Good learning across both days.” Denise Johnson, Becton Dickinson

Areas of expertise

This tutor delivers programmes in the following areas:

News & UpdatesContact Us

Our training experts are happy to discuss your needs.

Phone: 061 339040

Request a callback

News & UpdatesTutor blog posts

Making the best use of the FDA Inspections...

Our Life Sciences industry expert Tutor, Gerry Burke, makes some suggestions as to how Medical Device, Pharma and Biopharma manufacturers can make the best use the ongoing pause in FDA Inspections. The FDA has stated that it has ‘no ...

Read More