Skip to main content

Conducting a Life Sciences documentation and Training Gap Analysis

Compliance Key - Life science webinars 

Overview
The relationship between government regulations, actual job tasks performed by workers, compliance requirements, equipment maintenance and operational requirements, and process descriptions all are foundational to both the training that must be conducted in a regulated facility and the actual compliance documents that must be created to meet all regulatory requirements. How a training and documentation professional undertakes an analysis to determine these requirements directly influences the quality of the training developed and fielded and the completeness and relevance of the compliance documentation prepared. Many regulated industries have a multitude of documents to meet their regulatory needs, training materials, SOPs, Work Instructions, Job Aids, and Performance Tests etc. all independently prepared complicating document control and impacting individual document effectiveness. One of the keys to both effective compliance documentation and training is to develop documents that effectively serve a multitude of purposes - minimizing required regulatory control and maximizing utilization effectiveness.
Why should you attend this webinar?
The secret to effective compliance documentation and technical training lies in how the analysis is conducted and how training and compliance documentation are developed as a result of that analysis.
This webinar will provide the best practice approach for conducting an efficient, effective, and complete documentation and training analysis for a regulated environment as well as developing both training materials and compliance documents that effectively serve a multitude of uses. How well an analysis is conducted impacts cost, the speed of training delivery, and the quality of the regulatory documentation produced.
This webinar will guide the participant through the entire process from start to finish and will discuss how training materials and compliance documentation can be developed to meet complimentary purposes.
Areas Covered in the Session:
  • Elements of regulatory documentation and training
  • How regulatory documentation and training are linked
  • Regulatory compliance documentation hierarchies
  • The gap analysis - Areas of the organization/process that must be examined and analyzed
  • Conducting the gap analysis - using subject matter experts
  • Training task characteristics that impact training delivery
  • Use of the Analysis Tool to capture the required information
  • Performance objectives, how they are developed and how they impact the training process
Who can Benefit:
This webinar will benefit anyone in the training, regulatory, and compliance functions of any life sciences organization to include the following positions:

Comments

Popular posts from this blog

New 2019 HIPAA Guidance on De-Identifying Protected Health Information

Compliance Key  -   HIPAA Compliance Training Overview This seminar will be addressing how practice/business managers or compliance officers need to get their HIPAA house in order, as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major 2019 changes taking place with the Health and Human Services regarding the enforcement of the HIPAA law as well as detailed discussions on the Phase 2 audit process and current events regarding HIPAA cases (both in courtrooms and from real-life Audits). Our instructor - Mr. Brian Tuttle  has over 20 years of experience in working as Compliance auditor and has been an expert witness on multiple HIPAA cases. He`ll thoroughly explain on HOW and in WHAT scenarios patients can claim for cash remedies. More importantly, Brian will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Why should you attend this seminar? This Seminar will go over s

SOX Compliance: Accounts Receivable Risks and Controls

Overview The accounts receivable process includes the sub-cycles of acquiring and accepting customer orders; writing sales contracts; granting customer credit; shipping or otherwise delivering products or services; billing and recording sales and lease transactions; maintaining and monitoring accounts receivable; instituting effective collection procedures; recording and controlling cash receipts; establishing pricing and promotional activities; and properly valuing receivable balances. In management's selection of procedures and techniques of control, the degree of control implemented is a matter of reasonable business judgment. The common guideline used in determining the degree of internal controls implementation is that the cost of a control should not exceed the benefit derived. The Order to Cash Process (O2C) Process is comprised of several sub-processes that must have a foundation of internal controls for SOX 404 certification process. This webinar wil

How to Return Manufacturing to America Using Total Cost of Ownership Analysis?

How to Return Manufacturing to America Using Total Cost of Ownership Analysis? Michele Nash-Hoff Michele is founder and president of ElectroFab Sales, a sales agency specializing in helping manufacturers select the right processes for their products since 1985. She is currently a director on the board of the and the San Diego Inventors Forum and is also Chair of the California chapter of the Coalition for a Prosperous America. Michele is the author of Rebuild Manufacturing - the key to American Prosperity and Can American Manufacturing Be Saved? Why We Should and How We Can available at www.amazon.com. She has written regular articles for IndustryWeek?s e newsline, as well as many other e........ Read More Overview Moving manufacturing offshore led to the loss of 5.8 million manufacturing jobs and the loss of 60,000 companies and since the year 2000. What was the impact on the American economy? Is manufacturing returning to America? In this webinar, expert