Analytical Method Validation and Transfer

This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Oct-2019

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
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

Email: customercare@fdatrainingalert.com

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Why Should You Attend:

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this relative to the drug development process and have each expanded method validation requirements in recent years. However, with only limited guidance, industry has been left to interpret how to adequately comply with the regulations. This course provides a comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays. This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC.

Whether involved in method development, method validation, method verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered in validating methods to comply with today’s upgraded FDA CDER requirements. Lectures will include some of the more common mathematical and statistical treatments of validation data. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions. Methods utilized for the analysis of pharmaceuticals generate critical data in the determination of a product’s safety, identity, strength, purity, and quality. It is essential that the quality of the data is assured. Validation is required to demonstrate that these analytical methods are fit for their intended use. The validation data is also required by regulatory agencies for submissions.

This course will provide a thorough review of regulatory guidelines on method validation and transfer. Each element required to have a complete and thorough method validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement.

A review of validation protocol requirements and selection of appropriate acceptance criteria will also occur during the webinar session; as well as, a discussion on how to select suitable statistical calculations for reporting and interpreting the data.

Areas Covered in the Webinar:
  • Topic 1: Regulatory Requirements/Guidance on
  • This course will provide a thorough review of regulatory guidelines on method validation and transfer. Each element required to have a complete and thorough method validation will be discussed in detail to ensure course attendees have a clear understanding of each requirement.

    • Terminology defined: qualification, validation, revalidation and verification
    • FDA, EMA, ICH requirements and guidance
    • Validation lifecycle for analytical methods
  • Topic 2: Analytical Method Pre-Validation – Stage 1
    • Analytical Target Profile (ATP)
    • ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements
    • QC instrumentation qualification
    • Training
    • Critical assay reagent qualification
  • Topic 3: Analytical Method Validation Characteristics – Stage 2
    • Specificity, accuracy, precision, linearity, range
    • LOD and LOQ
    • Robustness and stability-indicating
    • Value of system suitability controls
  • Topic 4: Test Method Validation Protocol
    • Elements of a validation protocol
    • Pre-planning and planning steps
    • Identification and documentation of assay characteristics needing to be validated
    • Critical importance of assigning pre-defined acceptance criteria
  • Topic 5: Test Method Validation Report
    • Elements of the validation report
    • Elements of the validation protocol and the associated final validation report
    • Meeting the pre-defined acceptance criteria
    • Handling deviations/OOS’s, when (not if) they happen
  • Topic 6: Regulatory Concerns About Test Method Validations
    • Validation issues identified during the review of the submitted market dossier
    • Validation issues identified during regulatory inspections
    • Test method validation “continuous improvement” – ICH Q10
Who Will Benefit:
  • Analytical Development
  • Quality Assurance
  • Quality Control
  • Validation
  • Regulatory Affairs
Instructor Profile:
Kelly Thomas Kelly Thomas

Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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. FDATrainingAlert 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@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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