This webinar will provide valuable assistance to internal auditors, audit managers and personnel of regulated medical device or IVD companies.
Internal auditors should have a fundamental knowledge of Risk Management when performing assessments of their Quality Systems. ISO 13485 states the need to have "documented requirements for Risk Management throughout product realization." ISO 14971 requires risk management from early stages of design & development through the end of the product lifecycle. Internal auditors must be able to assess Risk Management for effectiveness, and must be able to assess use of risk management tools throughout the entire organization, from design and development to post-market feedback. This presentation will provide an understanding of the tools of risk management and how to integrate risk management into an effective internal audit program.
Areas Covered in the seminar:
- Internal audit requirements according to QSR and ISO 13485: What every internal auditor should know.
- Risk Management and Risk Assessment requirements according to QSR, ISO 13485 and ISO 14971.
- Basic implementation of audits and an audit program according to ISO 19011.
- Top-down approach to auditing Risk Management as a ’key process’.
- Auditing against ISO 14971: Roles & Responsibilities, Planning, Analysis, Evaluation, Control, Residual Risk Acceptability, RM Report, Production and Post-Production Information.
- Auditing against ISO 13485: Examples taken from Purchasing, Environmental Control, Control of NC Product, and Calibration.
- Auditing production and post-production feedback: Complaint Handling and CAPA.
- Adding value to the organization when performing internal audits of Risk Management or other processes.
Who will benefit:
This webinar will provide valuable assistance to internal auditors, audit managers and personnel of regulated medical device or IVD companies. The employees who will benefit include:
- RA/QA Managers and related personnel
- Audit Managers, Internal Auditors
- Risk Management personnel
- Internal process owners who will be audited to the requirements of Risk Management
- Consultants
Instructor Profile:
Phil Smart, is a founding member of RA/QA International LLC. He serves the medical device community as Consultant, Facilitator and Instructor to 21 CFR Part 820, CMDR/CMDCAS, MDD, ISO 13485, ISO 9001, ISO 14971, ISO 14644, ISO 14698 as well as MHLW/PMDA/Japanese PAL. He has been a European Notified Body Lead Assessor for over 15 years with auditing experience in a wide range of active and non-active medical device families, risk management, electrical safety testing, terminal EtO and Gamma sterilization, sterile packaging, environmental controls and clinical diagnostic laboratories.
