ComplianceOnline

Effective Training Practices for FDA Compliance

Instructor: Dr. Ludwig Huber
Product ID: 701665
Training Level: Intermediate
  • Duration: 75 Min

recorded version

$359.10
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$540.00
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(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

In this training you will learn what are the FDA requirements for training, how to develop an effective training program, training plan for individual employees, documentation, assessment, training tools available and specific training requirements for GXP and part 11.

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

Areas Covered in the Seminar:

  • 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.

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

Who Will Benefit:

  • Pharmaceutical and medical device industry
  • Manufacturers of pharmaceutical ingredients
  • Training departments
  • A 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 Director of Labcompliance and Chief Advisor for global FDA compliance at 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. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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