Quality Risk Management (QRM) Workshop

The workshop will focus on formality in QRM and how to achieve risk-based change control, which is a requirement of Annex 15 of the EU GMP.

Hosted by Kevin O’Donnell (Currently on Secondment from the HPRA to the PMDA in Japan and the Tokyo University of Science).

The workshop will focus on Formality in QRM, one of the more difficult topics addressed in the 2023 revision of ICH Q9, and on how to achieve risk-based change control, a key requirement of Annex 15.

Audience:

QA Managers, Manufacturing Leaders, Validation & Engineering, Regulatory Affairs, Quality Systems Specialists, QRM Leads, Change Control Coordinators, QC Staff or anyone looking to learn more about QRM.

By the end of the workshop participants will:

• Have achieved a better understanding of Formality in QRM.
• Have learned how to apply QRM to Change Control, addressing the question ‘What can go wrong?’ more effectively, and addressing the Annex 15 requirement that QRM be used to evaluate planned changes.
• Have seen good practices in relation to the treatment of GMP controls during Risk Assessment activities.
• Have learned how Risk Assessments can be directly linked with the design of qualification and validation protocols.

Please note there will be photography/videography taking place on the day.If you do not want to be captured, please let the event hosts know at the registration desk.

Agenda: