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Top 7 Essential Key Approaches for Achieving Compliance Excellence

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Course Description:

         Every organisation needs to abide by applicable laws and rules, failing which it may face serious consequences. But, how can organizations ensure that they comply with the relevant statutes and regulatory norms? What does it take to prevent a costly "compliance breach"?


Course Background:

         Quoting our presenter, Charles H. Paul, "The most simplistic solution to achieving compliance excellence is to do the right things right." This webinar is based upon a White Paper published by our presenter in 2016. It addresses the seven key approaches, that if performed with care and caution, will lead to compliance excellence in any highly-regulated environment.

         This webinar applies to all regulated industries - foods and beverages, cosmetics, pharmaceuticals, biologics, medical devices, and nutritionals.




Why should you Attend?

         In 2016, there were 4,528 483 warning letters issued by the FDA. The top three industries that received the majority of those warning letters were Foods with 2,196, Devices with 934, and Drugs/Pharmaceuticals with 281.

         The causes of those warning letters for Medical Devices for example, span the spectrum to include CAPAs, Complaint Handling, and MDRs. Most of the reasons for receiving those letters can be found among the seven keys for achieving compliance excellence that are taught in this webinar.

         Why attend this webinar...to prevent future warning letters from being issued by "doing the right things right" by applying the techniques that guarantee the realization of compliance excellence.

Areas Covered:

  • Key #1 - Understanding the regulations that pertain to your industry and your business throughout each level and function of your organization
  • Key #2 - Define your critical processes relative to the regulatory path that has been chosen
  • Key #3 - Develop sound regulatory documentation
  • Key #4 - Harmonize your processes and procedures between plants
  • Key #5 - Commit to and execute comprehensive technical training
  • Key #6 - Institute a sound and effective complaint and investigations handling process
  • Key #7 - Manage performance up and down the line to the performance structure created

Who will benefit?

This webcast will be of a valuable assistance to the below audience.

  • Supervisors
  • Managers
  • Directors
  • Senior Directors
  • Senior Management in all functions would benefit from this webinar

This webinar applies to all regulated industries - Food and Beverages, Cosmetics, Pharmaceuticals, Biologics, Medical Devices, and Nutritionals.

Associations/Societies:

  • American Society for Quality
  • Medical Device Manufacturers Association
  • European Medical Device Technology
  • Gulf Coast Medical Device Manufacturers
  • American Pharmaceutical Manufacturers
  • Generic Drug Manufacturers Association
  • National Food Processors Association of NFPA
  • US Food Processors Association

Registration Options


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.



Tags


FDA, Food and Beverages, Cosmetics, Pharmaceuticals, Biologics, Medical Devices, Nutritionals, Regulatory Documentation, Warning Letters, Compliance, Regulations, American Society for Quality, Medical Device Manufacturers Association, Medical Device Technology, Pharmaceutical Manufacturers, Drug Manufacturers Association, NFPA, Food Processors, Complaint and Investigation Handling, Harmonize Process

Speaker Details

Charles H.  Paul

Charles H. Paul

Regulatory & Management Consultant

Charles H. Paul is the President of C. H. Paul Consulting, Inc. A regulatory, manufacturing, training, and technical documentation consulting firm. Charles has been a regulatory and management consultant and an Instructional Technologist for over 20 years and has published numerous white papers on various technical subjects. He is a management consultant with specializations in Human Performance Engineering and Behavior, Operations Management, and Leadership and Organizational Development.

Refund Policy



Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@complyarena.com or call +1-888-222-5917 (Toll Free).