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    Online Seminar - Verification of Compendial Procedures According to the Updated USP Chapter <1226>

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    Website http://www.labcompliance.com/seminars/audio/273 | Want to Edit it Edit Freely

    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 experiments

    How 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 methods

    Inspection and enforcement practices: examples for FDA warning letters

    The background and scope of USP <1226>

    USP <1226> requirements

    What's new in the second revision?

    Compendial methods not requiring verification

    The USP verification process

    Risk based approach for type and extent of testing

    Performance characteristics for verification testing: proven industry examples

    Acceptance criteria for testing

    How much can compendial methods be changed

    Change vs. adjustment of compendial methods

    Investigating non-performance: root cause and corrective actions

    Documenting the verification experiments and results

    And for easy and instant implementation:

    download 10+ documents from special seminar website

    SOPs:

    - Verification of Compendial Methods

    - Change vs. Adjustments of Compendial Methods

    - Validation of Chromatographic Methods

    Checklist:

    - Verification of Compendial Methods

    - Validation of Analytical Methods and Procedures

    Reference Article

    - Validation of Standard Methods

    - Validation of HPLC Methods

    - Validation of analytical methods: review and procedures

    Warning letters and/or Inspectional observations related to verification of compendial methods

    USP Presentation with test examples: Verification of Compendial Procedures

    Proposed revision of the USP <1226> (link)

    FDA Guidance

    - Analytical procedures and methods validation

    ICH Guidelines for the Industry

    - Text on Validation of Analytical Procedures

    - Validation of Analytical Procedures: Methodology

    Who should attend?

    Laboratory managers and staff

    Analysts

    QA managers and personnel

    Regulatory affairs

    Training departments

    Documentation department

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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