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:
Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

HIPAA Compliance with the New Omnibus Rule: How to Pass an Audit to Avoid Penalties and Criminal Convictions

Compliance Key INC  -  H ipaa webinar                                           Jonathan P. Tomes Jonathan P. Tomes , J.D., is Keynote Speaker at Compliance key Inc. He is a health care attorney practicing in the greater Kansas City.   Webinar Id:   HIPHJPT001  2:30 PM PT | 03:30 PM ET    01/18/2018  Duration: 60 mins  Overview Before the HITECH Act, DHHS could audit covered entities for HIPAA compliance, but did not have to. With that Act, now the must audit those entities and business associates as well. In the first audits, the Phase I audits, DHHS came on site. The subsequent Phase II audits, however, were paper audits in which those audited had to provide documentation of their compliance. As yet, we do not know what form Phase III will take, but the necessary actions to prepar...
Post a Comment
Read more

HIPAA Compliant Fundraising Under New Rules - 2019

Compliance Key  -  H ipaa   Compliance Training HIPAA Compliant Fundraising Under New Rules - 2019 Joel Simon Joel Simon is one of the nation's leading experts on the fund raising aspects of HIPAA. Joel has been a member of the Maryland bar for 30 years, and his professional experience includes work as the assistant general counsel of a community hospital. Joel is an editor of "Fundraising Under HIPAA" published by the Association of Fundraising Professionals. He has lectured on Fund Raising under HIPAA to national audiences since the original HIPAA regulations were first proposed 17 years ago. Read More Overview Not-for-Profit organizations that are governed by HIPAA often need or want to fund raise from their patients, clients, or families. What protocols should be in place to maximize philanthropic opportunities under HIPAA? What compliance measures need to be in place and assessed to properly use protected health information for fund raisi...
Post a Comment
Read more

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 Sem...
Post a Comment
Read more