Global Quality Standards – the new approach to compliance documentation

    /Charles  /H. Paulspeaker of Training Doyensinvite
    Speaker: Charles H. Paul


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    Duration: 60 Minutes
    Product Code: 50489
    Level: Intermediate

OVERVIEW

Standard Operating Procedures and work instructions – the compliance documentation required by regulation – are essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide.  Regulated documentation can serve a variety of purposes other than meeting a regulatory requirement – as training materials, to standardize operations, to manage individual and group performance, to identify the sources of deviations, etc.  The key is to knowing how to write standard operating procedures and work instructions to properly meet those needs.

The approach and philosophy here are new to the industry and focus on achieving maximum benefit of compliance documentation across many applications to achieve both operational efficiencies and compliance excellence.  This webinar will address the new thinking as to how documentation hierarchies should be organized to reflect a global focus on how your documentation should be structured.

This webinar will also discuss how to transform your regulatory documentation process a profit center, an operational force multiplier in how you run your business, and an effective central focus of your technical training function

WHY SHOULD YOU ATTEND

Writing effective Standard Operating Procedures and Work Instructions is not intuitive, it is not a skill that is often taught in our universities, and it can be a difficult and cumbersome task to execute. Knowing the most effective and efficient processes for gathering, organizing, and writing technical documentation is absolutely critical to providing significant value to a dreaded, avoided, and seemingly (and wrongfully) unimportant work task.

AREAS COVERED

  • Define the true purpose and function of regulatory documentation.
  • Determine the value add that regulatory documentation can bring to your organization.
  • Identify the pitfalls associated with writing regulated documentation.
  • Explain the purpose and function of a documentation hierarchy – and the new global thinking concerning documentation hierarchies.
  • Explain how documentation is created.
  • Identify and explain the best types of formats that can used to develop standard operating procedures and work instructions
  • Explain the best techniques for gathering the technical information you need to develop your documents.
  • Explain how to most effectively work with Subject Matter Experts.
  • Explain how to streamline regulatory document management system and manage technical document reviews

LEARNING OBJECTIVES

  • Compliance documentation should never be developed to simply meet a regulatory requirement.
  • Compliance documents, properly crafted, can significantly minimize the training burden faced by life sciences companies today.
  • Compliance documents, properly crafted, can virtually eliminate the potential for deviations throughout the operation.
  • Compliance documentation, properly crafted, is a valuable performance management tool for both managers and associates alike.

WHO WILL BENEFIT

Anyone tasked with the development of regulatory documentation in any regulated industry -  the Life Sciences (medical devices, pharmaceuticals, biologics, etc), foods, cosmetics, beverages, nutraceuticals, etc.

This webinar has a very broad base from which to solicit participants.  Virtually any regulated industry as previously defined and virtually any job classification level – associates through managers and in virtually any organizational function – operations, facilities, logistics, purchasing, laboratory, research and development, engineering, maintenance, etc.

SPEAKER

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 to the life sciences industry 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 human performance problems.

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