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

Essentials of Affirmative Action and OFCCP Compliance

Compliance Key INC  -  Human Resource Training Online                                                                  Janette Levey Frisch Janette Levey Frisch is Keynote Speaker at Compliance key Inc. She is founder of  The EmpLAWyerologist Firm, has over 20 years of legal experience, more than 10 of which she has spent in Employment Law. It was during her tenure as sole in-house counsel for a mid-size staffing company headquartered in Central New Jersey, with operations all over the continental US, that she truly developed her passion for Employment Law.   Webinar Id:   CICJE001  10.00 AM PT | 01.00 PM ET   01/09/2018  Duration: 90 mins  Overview If you are a federal contractor, having a firm grasp on the essentials ...

Understanding Design Controls

Compliance Key INC  -  Medical Device Training Overview Design Controls are the processes used to design, develop, and manage medical devices that you manufacture. They are mandated by federal regulation, however, the regulations concerning design controls are vague in terms of the specific process steps required and the approaches that should be taken to achieve compliance should be developed. Knowing how the FDA both views and examines design controls is crucial to achieving compliance throughout the life of the medical devices you manufacture and is one of the most valuable compliance subject areas to explore. Noncompliance in design controls, which are consistently uncovered by the FDA during inspections and examinations, are concerned with the design control process that has been designed and applied and the documentation required to support each design control step. The specific sections of the regulations that apply to design controls include CFR 21 Part 820 Qua...

Building a Compliance Program

Compliance Key INC  -  Compliance Training Webinar                                   Lisa M. Marsden Lisa M. Marsden, IACCP, is Keynote speaker at Compliance Key, Inc. She is the president and founder of Coulter Strategic Services. Coulter Strategic Services provides financial advisors and consulting firms with compliance and project management services. Prior to that, Ms. Marsden was the chief operating officer/chief compliance officer of Financial Trust Asset Management, Boca Raton, Florida.  Webinar Id:  CICLB005  10:30 AM PT | 01:00 PM ET  05/15/2018  Duration 60 mins  Overview Whether you are creating a new compliance program as a new CCO or a new firm or if you are updating an existing program this webinar will guide you through the process. Why should you attend this webinar? Rule 17j-1. Effective Date: A...