Effective Training Practices for FDA Compliance

Speaker

Instructor: Dr. Ludwig Huber
Product ID: 702513

Location
  • Duration: 75 Min
This webinar will provide participants a good understanding of FDA requirements for training and provide recommendations for implementation.
RECORDED TRAINING
Last Recorded Date: Oct-2012

 

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

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

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Email: [email protected]

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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.

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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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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