Best Practices to Prepare for and Manage Compliance Audits by EU Notified Body and FDA - By Compliance Global Inc

New Hyde Park, NY, April 29, 2015 --(PR.com)-- 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

About Compliance Global Inc:

Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.

Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.