Online Training for Laboratory Compliance- Pack of two courses

Instructor: Dr. Ludwig Huber
Product ID: 700996
  • Duration: 120 Min
ComplianceOnline brings you a pack of 2 courses covering two of the major compliance areas faced by Clinical Laboratories.

Training CD / USB Drive

$1,000.00 (20%)
Save $200.00
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: +1-650-362-2367


Read Frequently Asked Questions

Clinical Labs are a tough environment to be in. Not only are there a multitude of rules, there are a number of areas which are not very clearly defined. On top of all this, the rules keep changing all the time.

Module1:Transfer of Analytical Methods and Procedures:FDA Requirements and Strategies and Tools for Implementation (click on the link to view detailed description)

Areas Covered:

  • FDA and International regulations for method transfer.
  • Examples of FDA warning letters and how to avoid them.
  • The new FDA Guidance on method transfer.
  • Developing an SOP and SOPP and transfer plan.
  • Responsibilities of the transferring and receiving laboratory.
  • Method transfer options.
  • Criteria for transfer waiver (omission of formal transfer).
  • Types of method transfer and testing.
  • Conducting comparative studies.
  • Most likely failures during method transfer.
  • Handling deviations.
  • Method transfer protocol and summary report.

Module2:Verification of Compendial Methods Understanding the New USP Chapter <1226> (click on the link to view detailed description)

Areas Covered:

  • FDA and international requirements.
  • The background on scope of USP <1226>.
  • Compendial methods not requiring verification.
  • USP <1226> requirements and processes.
  • Risk based approach for testing.
  • Criteria and examples for degree and extent of the verification.
  • Performance characteristics for verification.
  • Verification for drug substances and dosage forms.
  • Handling deviations.
  • Documenting the verification experiments and results.

Instructors Profile:

Ludwig Huber, 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 Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press. He is also the author of the Macro & Spreadsheet Quality Package from Labcompliance. For more information, visit Dr. Huber’s website: .

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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 call +1-888-717-2436 (Toll Free).

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