ComplianceOnline

Effective Training Practices for FDA Compliance

Instructor: Dr. Ludwig Huber
Product ID: 701243
  • 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
Last Recorded Date: Jan-2014

Training CD / USB Drive

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

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This FDA compliance webinar will help the attendees develop an effective training program and training plans for an organization. Attendees will learn GxP training requirements in US and EU.

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.

What Attendees will Learn:

  • 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.

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.

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

Who Will Benefit:

  • Pharmaceutical and medical device industry
  • Manufacturers of pharmaceutical ingredients
  • 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 Director of Labcompliance and editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. Mr. Huber is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. Dr. Huber has given more than 200 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. For more information, visit Dr. Huber’s website: www.ludwig-huber.com

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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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