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
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.
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
- Create the regulatory foundation for the establishment of life sciences business
- 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:
- Quality Assurance
- Regulatory submissions
- R&D personnel
- Life Sciences Compliance Professionals
- Training/ Operations Professionals
- Manufacturing/ Technical Assurance Personnel
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.