Overview This webinar is intended to help you get familiar with compliance audits by the US Food and Drug Administration and Notified Bodies in European Union (EU). This webinar is further intended to help you understand what you can do to best prepare for and manage the audits by EU Notified Bodies and FDA with increased awareness. The FDA enforcement actions have recently increased. In EU, EU commission issued recommendation concerning unannounced audits by notified bodies in medical device industry. As a medical device firm, you are subject to regulatory audits or inspection by the US FDA and EU notified body if you bring your medical device products into the US and EU countries allowing CE-marked products. This webinar will cover the details of how you can proactively prepare for and manage the audits. Why Should You Attend • To learn how to adequately prepare for and manage regulatory audits by the US FDA and EU notified bodies. Areas Covered in the Session • Laws and Regulations: US and EU • Definitions • EU Unannounced Audits • Overview of both ISO 13485 and FDA 21 CFR 820 • Understanding Auditing Strategy • Audit Objectives and Process • Auditing Quality Management Systems • Internal Audit Programs • Quality Systems and Subsystems in ISO 13485 and under 21 CFR Part 820 • FDA and ISO 13485 training • Common Mistakes/Misconception: How to Avoid Them • Communication during Audit or Inspection: Dos and Don’ts • Good Practices: Dos and Don’ts • Conclusion Learning Objectives This webinar will cover the details of how you can proactively prepare for and manage the audits. Who Will Benefit • Regulatory Affairs Consultants • Quality Site Professionals • R&D Professionals • Complaint And Risk Management Personnel • Consultants • Contractors/Subcontractors • CEOs • VPs • Clinical Affairs Consultants • Other Interested Parties Level Intermediate

1. Best Practices to Prepare for and Manage Compliance Audits
by EU Notified Body and FDA
Thursday, May 28, 2015 | 01:00 PM EDT, Duration: 60 min, Course Level: Intermediate
Webinar by Dr. David Lim
Overview
This webinar is intended to help you get familiar with compliance audits by the US Food
and Drug Administration and Notified Bodies in European Union (EU).
This webinar is further intended to help you understand what you can do to best prepare
for and manage the audits by EU Notified Bodies and FDA with increased awareness.
The FDA enforcement actions have recently increased. In EU, EU commission issued
recommendation concerning unannounced audits by notified bodies in medical device
industry.
As a medical device firm, you are subject to regulatory audits or inspection by the US
FDA and EU notified body if you bring your medical device products into the US and EU
countries allowing CE-marked products.
This webinar will cover the details of how you can proactively prepare for and manage
the audits.
Why should you attend?
• To learn how to adequately prepare for and manage regulatory audits by the US FDA
and EU notified bodies.
Areas covered in the session
• Laws and Regulations: US and EU
• Definitions
• EU Unannounced Audits
• Overview of both ISO 13485 and FDA 21 CFR 820
• Understanding Auditing Strategy
• Audit Objectives and Process
• Auditing Quality Management Systems
• Internal Audit Programs
• Quality Systems and Subsystems in ISO 13485 and under 21 CFR Part 820
• FDA and ISO 13485 training

2. • Common Mistakes/Misconception: How to Avoid Them
• Communication during Audit or Inspection: Dos and Don’ts
• Good Practices: Dos and Don’ts
• Conclusion
Learning objectives
• This webinar will cover the details of how you can proactively prepare for and manage
the audits.
Who will benefit
• Regulatory Affairs Consultants
• Quality Site Professionals
• R&D Professionals
• Complaint And Risk Management Personnel
• Consultants
• Contractors/Subcontractors
• CEOs
• VPs
• Clinical Affairs Consultants
• Other Interested Parties
Instructor profile
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim frequently presents global
regulatory and quality compliance topics including 510(k) and PMAs in various
forums and meetings. Recently, Dr. Lim developed 510(k) and PMA templates
ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim
developed FDA inspection checklists for drug and medical device
manufacturers based on his analysis of FDA inspectional observations cited in
483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g.,
US FDA) through public comments and also served as a panel member during the FDA’s
transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs
Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all
research projects including, but not limited to, pharmacovigilance, medical device
reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider at FDA
news.