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

Speaker

Instructor: Dr. Ludwig Huber
Product ID: 700123
Training Level: Intermediate to Advanced

Location
  • Duration: 60 Min
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.
RECORDED TRAINING

 

$99.00
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)

$199.00
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

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

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 [email protected] 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 www.labcompliance.com, 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: www.ludwig-huber.com

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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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