Managing Multi Track Audits

Why Should You Attend:

Whether you are a novice in managing audits, or a well-experienced professional, managing audit with multiple auditors and multiple audit paths can be especially challenging.

Do you know

• Why audit management is important in the success of an audit?
• What resources are needed for the audit team? (Rooms, internet access, etc.)
• How to identify persons who will be involved in the audit?
• How to prepare each audit team member for their specific role as an Audit Leader, Subject Matter Expert, Back Room Leader, Back Room Staff and runners, Audit Scribe, Audit Coordinator, and support staff?
• How to prepare schedules for each audit track and the resources needed?
• How to communicate audit preparation details to senior management?
• How to communicate audit preparation to all affected employees?
• How to manage scheduling changes and conflicts?

This course is designed to help you overcome these challenges.

Today’s Quality System and regulatory audits are becoming more complex, as regulations and practices change. With the advent of the revised European Union Medical Device Regulations, (EU MDR) and the implementation of the Medical Device Single Audit Program (MDSAP), many companies will experience a reduction in the overall number of external audits, but a significant expansion in the scope and coverage of the audit. ISO registrars may be auditing for compliance to multiple regulations and product specific requirements. Companies will continue to be expected to provide documents, records and SME’s in a timely manner. With the advent of programs such as MDSAP, response times may be more restrictive, and delays could result in derogatory audit results.

For global and matrixed organizations, these expanded audits can be especially challenging, due to operations in various geographies, time zones, and regulatory environments. Preparation is vital and this course is designed to provide the processes and tools to help you with that preparation and to ensure effective audit management, regardless of the audit’s complexity.

Areas Covered in the Webinar:

• Audit Roles and responsibilities
• Audit Scheduling and communication
• Audit Etiquette
• Preparing Audit team members for success
• Preparing senior management for audit support and involvement
• Preparing employees for auditor interactions
• Audit communication
• Audit recordkeeping

Who Will Benefit:

• Quality Managers
• Regulatory Affairs Managers
• Clinical Affairs Managers
• Senior Management
• Document Control Coordinators
• Engineering Staff
• Quality Staff

Deb Simpson
Quality Management Professional, Carestream Dental

Deb Simpson is a seasoned Quality Systems management professional and consultant in the Life Sciences industry. As the most senior Quality leader, Deb has successfully led and managed countless external audits for her employers and clients, including ISO, FDA, AATB, and compound audits. Deb holds certification as a lead auditor for both ISO 9001 and 13485, and has experience with a variety of regulated products, including implantable, injectable, and combination products, both active and inactive.

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