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Achieving Regulatory Compliance in the Life Sciences - Step by Step

4425
Duration : 60 Minutes

Charles H. Paul,

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults Read more


This webinar will take the participant on a journey that begins with an organizational clean slate and builds all of the key pieces that are essential for both compliance and operational excellence.  Compliance and operational excellence are not mutually exclusive.  They can and should be consider together as crucial to making the business work effectively, efficiently, and in a compliant manner.

All of the building blocks presented fit together – they are dependent upon each other and this webinar will establish that dependency and its importance. 

The building blocks for achieving compliance excellence have been divided into seven distinct components making them easy to understand and apply.

Course Objectives:

At the completion of this webinar, participants will be able to:

• Understand the regulations that pertain to your industry and your business throughout each level and function of your organization
• Define your critical processes and explain why that is important
• Explain the benefits of developing sound regulatory documentation
• Explain why harmonizing your processes is critical to consistency in operations and regulatory compliance
• Explain why technical training is essential to every aspect of business operations to include meeting and exceeding regulating requirements
• Institute a sound and effective complaint and investigations handling process

Why Should You Attend:

Certainly the most simplistic solution to achieving compliance excellence is “to do the right things right!” But what does this really mean?

I have distilled the “doing the right things right” solution into 7 separate individual keys or actions that will provide a solid foundation for the establishment of any compliance program.

Why should you attend this Webinar?  Because as much as we try, most regulated industries don’t have a set approach for developing a compliance program that is integrated into the fabric of their organization, that serves real valuable functions to improve operations, improve and maintain human competence, and enhance competitiveness.  Compliance and regulatory affairs are viewed in many cases as a “non-value add”  that is an expense and not an asset, that is a “check-the-box” to be completed in the event that there is a regulatory audit or issue and because it is required. 

This is so far from the case – this is so far from reality.  For many, it is a grossly missed opportunity.   Regulatory compliance properly applied can be for the organization, the keys to success, the one function within the company that drives success and achieves real results.

It is not bad to standardize your operations.  It is not bad to build your operations around safety and efficacy.  It is not bad to structure an organization that exceeds your regulatory responsibilities while at the same time optimizing every function within the company that the regulatory processes touches.

This webinar will provide the approach and framework that you need to follow to make your compliance program a valuable ingredient in the process of running your business.

Course Outline:

• The regulations that pertain to your industry and your business
• Importance of defining your critical processes
• Benefits of developing sound regulatory documentation
• Harmonizing your processes for consistent operations and regulatory compliance
• Technical training and its importance
• Complaint and investigations handling process
• Performance management

What You Get:

• Training Reference Materials
• Live Q&A with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

Across the functions of the company to include – operations, logistics, regulatory, quality, laboratory, etc.

• Associates
• Supervisors
• Managers
• Directors
• Vice Presidents

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

100% MONEY BACK GUARANTEED

Refund / Cancellation policy

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Subject : Achieving Regulatory Compliance in the Life Sciences - Step by Step


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