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Online Seminar - Verification of Compendial Procedures According to the Updated USP Chapter <1226>
Website http://www.labcompliance.com/seminars/audio/273 |
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Category Pharmaceutical, analytical methods, validation
Deadline: September 01, 2011 | Date: September 01, 2011
Venue/Country: Online, Online
Updated: 2011-08-18 02:05:34 (GMT+9)
Call For Papers - CFP
Compendial methods such as USP and EP standards are validated by the organizations that have developed and published the method. The FDA requires users of such methods to demonstrate the user's competence to successfully run the method. For example, 21 CFR 211.194 (a) states: The suitability of all testing methods used shall be verified under actual conditions of use. However, the FDA does not give any further guidance and the first revision of USP <1226> did not have specific recommendations. Now USP has announced to come out with a new revision using the risk based approach for the type and extend of testing. Because there are no further guidelines there are still many questions.Key Questions are:What are FDA and international requirements for compendial methods?What and how much should be tested?How to use the risk based approach?Is system suitability testing enough?Do all compendial routine methods require verification?When could just system suitability testing be enough?Should we verify all performance characteristics?How much can we deviate from the compendial method without the need for a full revalidation?What to do if I the compendial procedure can not be verified?How frequently should compendial methods be re-verified?What if our equipment was not included in the USP method validation experimentsHow does the this audio seminar help:Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present the requirements for method verification and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, real world case studies for testing, worksheets, templates and examples will help immediate and cost effective implementation.During the interactive presentation you learn about:FDA and international requirements for verification of compendial methodsInspection and enforcement practices: examples for FDA warning lettersThe background and scope of USP <1226>USP <1226> requirementsWhat's new in the second revision?Compendial methods not requiring verificationThe USP verification processRisk based approach for type and extent of testingPerformance characteristics for verification testing: proven industry examplesAcceptance criteria for testingHow much can compendial methods be changedChange vs. adjustment of compendial methodsInvestigating non-performance: root cause and corrective actionsDocumenting the verification experiments and resultsAnd for easy and instant implementation:download 10+ documents from special seminar websiteSOPs: - Verification of Compendial Methods- Change vs. Adjustments of Compendial Methods- Validation of Chromatographic MethodsChecklist: - Verification of Compendial Methods- Validation of Analytical Methods and ProceduresReference Article- Validation of Standard Methods- Validation of HPLC Methods- Validation of analytical methods: review and proceduresWarning letters and/or Inspectional observations related to verification of compendial methodsUSP Presentation with test examples: Verification of Compendial ProceduresProposed revision of the USP <1226> (link)FDA Guidance- Analytical procedures and methods validationICH Guidelines for the Industry- Text on Validation of Analytical Procedures- Validation of Analytical Procedures: MethodologyWho should attend?Laboratory managers and staffAnalystsQA managers and personnelRegulatory affairsTraining departmentsDocumentation departmentKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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