Auditing Basics and Fundamentals for Medical Devices and Drugs
Frank Pokrop has worked in the medical device arena for more than 20 years and he is employed at Sotera Wireless in San Diego as the Senior Director for Regulatory Affairs and Quality Assurance. His prior experience covers manufacturing quality assurance for large and small volume parenteral drugs.
Frank’s responsibilities cover management of staff and budget, global submissions, worldwide regulatory intelligence, project management, auditing and compliance, recall management, and training. In one role with a Fortune 100 company, he was the formal liaison to the FDA and worldwide health agencies representing drugs, devices, IVD’s and infant formula and in this role, he reported to a corporate officer. For eight years he managed a worldwide auditing program covering 48 global sites and at a different company, he was an independent reviewer of corporate audits.
A long-standing supporter of training and personnel development, Frank has spent a considerable amount of time in volunteer positions including: (1) He was a member of MD&DI's Editorial Advisory Board from 2006 - 2016, (2) He has been an officer and volunteer with the San Diego Regulatory Affairs Network (SDRAN) since 2010 and was president in 2017, (3) He has been a member of the “B” IRB at UCSD since 2015, and, (4) He has taught an introductory course on medical devices at UCSD since 2017. He is a frequent contributor and speaker with ASQ and RAPS both locally and at national meetings. While at SDRAN he organized seminars on jobs and careers and routinely assisted members with resumes, cover letters and finding employment.
His certifications include: RAC, CSQE, CISA and CPGP.
Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundamental tool of risk management. The auditor assures alignment with prescribed practices and is at the front line in evaluating control systems, testing, measurement and more. Auditors asses the accuracy, timeliness, and reliability of information.
Learn how to perform these important duties and comply with the professional auditing standards. This course provides an overview of the "audit life cycle", including audit planning, conducting fieldwork, interviews, walkthroughs and tests of controls, and audit reporting and follow-up. Designed for internal auditors who are new or have limited experience in the audit profession, this short seminar will walk the participants through the basics of being an internal auditor.
FDA and other worldwide health authorities all require that quality system audits take place in one form another. Audit effectiveness can be enhanced through training and the appropriate background and introduction and this course serves to help with that goal.
- Background Information – why are audits necessary?
- Auditing Basics
- Traits/Skills of a Good Auditor
o Potential Interview Problems
- GMP Background Information for Auditors
- Audit scheduling
- Pre-Audit Information
- Pre-audit preparation
- Conducting the Audit
- Common Items to look for in an Audit
- Audit reporting and closeout
- Unresolved issues
Course Level - Basic/fundamental to intermediate levels
Who Should Attend
- Managers of the audit function
- Directors who are new to the audit function
- Individuals or departments with young, new or inexperienced personnel assigned to auditing
- Personnel interested in auditing
Why Should Attend
- Understand the quality system requirements and the role of auditing
- Learn and review the basics of auditing
- Recognize the required steps for a sound audit approach
- Hear about the functions of hard and soft skills
- Develop a consistent approach to the lifecycle of an audit
- Learn about the characteristics of a good auditor
- Discuss resources, standards and laws