Analytical Method Validation and Transfer

Duration: 90 Minutes
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, the 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.
Analytical Method Validation and Transfer
Instructor: Kelly Thomas
Product ID: 506228
In this webinar we 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.

Objectives of the Presentation
  • Regulatory Requirements/Guidance on Analytical Method Validation
    • Terminology defined: qualification, validation, revalidation and verification
    • FDA, EMA, ICH requirements and guidance
  • Analytical Method Pre-Validation - Stage 1
    • Analytical Target Profile (ATP)
    • ICH Q8, Q9 and Q10 adherence - Pre-Validation Requirements
  • Analytical Method Validation Characteristics - Stage 2
    • Specificity, accuracy, precision, linearity, range
    • LOD and LOQ
  • Test Method Validation Protocol
    • Elements of a validation protocol
    • Pre-planning and planning steps
  • Test Method Validation Report
    • Elements of the validation report
    • Elements of the validation protocol and the associated final validation report
Why Should you Attend
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.

Who will Benefit
  • End-users responsible for testing
  • QA managers and validation personnel
  • Analytical development managers and personnel
  • Senior Quality and R&D Management
  • Regulatory and Compliance Professionals
  • Contract Manufacturing and Contract Testing Facilities
  • Auditing Management and Professional
  • Quality Control staff
  • Quality system auditors
  • Metrology
  • Training departments
  • Consultants
$200
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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.
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