ComplianceOnline

Effective Training Practices for FDA Compliance

Instructor: Dr. Ludwig Huber
Product ID: 702513
  • Duration: 75 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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

Course "Effective Training Practices for FDA Compliance" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

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 session will help you gain a good understanding of FDA requirements for training and provide recommendations for implementation.

Free Hand-outs:

For easy implementation, attendees will receive

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

Learning Objectives:

  • 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:

Pharmaceutical development and quality control, API manufacturers, medical device development and manufacturers, contract laboratories and CROs will benefit from this training

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

Instructor Profile:

Dr. Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

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