Online Training for Laboratory Compliance- Pack of two courses

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 www.labcompliance.com, 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: www.ludwig-huber.com .

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