Speaker: Charles H. Paul - President of C. H.
Paul Consulting, Inc
Date: December 13th Tuesday
Time: 01:00 PM EST | 10:00 AM PST
Duration: 60 Minutes
Product Code: 300187
Level: Intermediate
Key Take Away
This
webinar will explain a logical coordinated process that addresses why each
critical aspect and function of the organization is essential to building
compliance and operational excellence into the very fabric of the organization.
Overview
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.
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 touch.
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.
Areas Covered In This
Webinar
·
Understanding the regulations that pertain to your industry and
your business throughout each level and function of your organization
·
Defining your critical processes and why that is important
·
The benefits of developing sound regulatory documentation
·
Why harmonizing your processes is critical to consistency in
operations and regulatory compliance
·
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
·
Performance management – the glue that holds everything together
and guarantees acceptable performance throughout the organization
Learning Objectives
·
Define why establishing and defining your processes is crucial
to properly applying the right regulations to every aspect of your business
·
Explain the role that regulatory documentation plays in insuring
both sound regulatory compliance and effective operations training
·
Define the process of harmonization as it relates to your
processes and operations and why it is important
·
Explain why technical training is in reality the cornerstone of
business effectiveness, safe and compliant operations, and worker competence
·
Define the relationship between process definitions, regulatory
compliance, compliance documentation and technical training
·
Define why an effective CAPA system is critical to meeting
regulatory requirements
·
Explain how performance management is critical to insuring that
the compliance process works at all levels in the organization
Who Will Benefit
This
webinar will provide valuable assistance to all personnel in:
·
Scientists
·
Technicians
·
Engineering
·
Manufacturing
·
Quality Assurance
·
Regulatory submissions
·
R&D personnel
·
Life Sciences Compliance Professionals
·
Training/ Operations Professionals
·
Manufacturing/ Technical Assurance Personnel
Speakers Profile
Charles H. Paul is the President of C.
H. Paul Consulting, Inc. – a regulatory, training, and technical documentation
consulting firm.
Charles
has been a regulatory consultant for over 20 years and has published numerous
white papers on the subject. The firm works with both domestic and
international clients designing solutions for complex training and
documentation issues.
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