Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness

Instructor: Dr. Ludwig Huber
Product ID: 700123
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

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

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


Read Frequently Asked Questions

This FDA compliance training will guide attendees through the entire process from establishing trainings, through developing and implementing training plans to FDA compliant documentation of effectiveness.

Why Should You Attend:

No or inadequate training of employees is one of most frequently cited deviations in FDA inspection 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.

What Attendees will Learn:

  • FDA training requirements
  • 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.
  • Developing an SOP for Trainings
  • Assessment of effectiveness
  • Documentation of trainings for the FDA
  • Specific training requirements for part 11

Additional benefits:

Attendees will receive a checklist, an SOP and a 30+ pages primer on Trainings.

Note: These complimentary hand-outs will be sent to customers on request. Please email for these documents, stating your order number, and they will be emailed to you within 4 working days.

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

Instructor Profile:

Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".For more information, visit Dr. Huber’s website:

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Product Reviews Write review

Hand outs sent were very good tools.
- Anonymous

Presentation materials were excellant.
- Anonymous

Instructor was knowledgeable.
- Anonymous

Great Material, Great Subject, Very Knowledgeable Presentor.
- Anonymous

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