Achieving World Class Regulatory Compliance in the Life Sciences


Thursday, February 28, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 60 Minutes      

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Duration: 60 Minutes  

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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.
Charles H. Paul   Product Id : 502322
  Instructor : Charles H. Paul

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Overview:

This webinar will address each of the 7 keys to compliance excellence that form the foundation for any excellent organization. We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization.

#1 - Understand the regulations that pertain to your industry and your business throughout each level and function of your organization. It is the responsibility of every regulated organization to interpret those governing regulations as they pertain to the company's unique product and processes and apply those interpretations throughout the organization. In most cases, this will require the assistance of outside industry and regulatory experts to make these interpretations and the case for the direction that the company chooses to go.

#2 - Define your critical processes relative to the regulatory path that has been chosen. Many organizations do not adequately define their processes. These process definitions are the first rung on the ladder, the "50,000 ft. view," the genesis of the operational and regulatory paradigms that will form the structure of how the business will be run in an efficient, effective, and compliant manner.

#3 - Develop sound regulatory documentation. Documentation should not simply meet a regulatory requirement but be designed to effectively direct operations, be foundational to a comprehensive worker training approach, and serve as the basis for a sound continuous improvement process.

#4 - Harmonize your processes and procedures between plants. Best practices should be determined for "like" operations, equipment, processes, etc. and then implemented across all facilities and locations where those "like" operations exist.

#5 - Commit to and execute comprehensive technical training. Competence is the prerequisite to competition and compliance. If your goal, on the other hand, is to create an organization that meets or exceeds your regulatory responsibilities, demonstrates operational excellence, develops and deploys superior competence, and truly demonstrates the attributes of a learning organization, you must invest in training infrastructure, organizationally support training, provide training a seat at the operations and regulatory tables and include the function in the decision-making and advisory processes, and consistently execute an effective training process for both new and existing human resources.

#6 - Institute a sound and effective complaint and investigations handling process. It is essential that CAPA systems and processes be fully integrated with corporate strategies and policies and there be a commitment up and down the organizational structure to fully execute the process.

#7 - Manage performance up and down the line to the performance structure created. If it is not managed it will not be performed.Regulatory compliance must be sacrosanct and an enforceable component of the performance management system. That message must be sent and received throughout the organization.

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.

Areas Covered in the Session:

  • 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

Who Will Benefit:
  • Directors
  • Managers
  • Scientists
  • Technicians
  • Associates


Speaker Profile
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

He has dedicated his entire professional career explaining the benefits of performance-based training




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