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EVENT DATES
Apr 2016
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Webinar on Effective Training Practices for FDA Compliance

Online Event
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Overview

Overview: 

No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.

This webinar will give a good understanding of FDA requirements for training and provide recommendations for implementation.

Reference material for easy implementation:

  • Primer: Successful compliance training (20 pages)
  • SOP: Training for GMP Compliance
  • SOP: Training for GxP, 21 CFR Part 11 and Computer Validation

Areas Covered in the Session:

  • GxP training requirements in US and EU 
  • Most frequently cited deviations
  • Developing an effective training program for a company, site or department.
  • Developing a training plan for individual employees 
  • Who can or should be responsible for the training program and training plans.
  • Most efficient training tools for different tasks.
  • Assessment of successful participation
  • The benefits of risk based training
  • Documentation of trainings for the FDA
  • Specific training requirements for Part 11

Who Will Benefit:

  • Training departments
  • QA managers and personnel 
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Documentation department
  • Consultants

Speaker Profile:

Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com

Contact Detail:

Compliance4All DBA NetZealous
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://bit.ly/Effective_Training_Practices

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