Webinar Includes : All the training handouts , certificate ,Q/A and 75 mins Live Webinar
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.
Topic 1: Regulatory Requirements/Guidance on Analytical Method
• 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
• 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
Personnel from the pharmaceutical and medical device industry
• Manufacturers of drug substances (APIs)
• Contract laboratory staff
• Laboratory managers and staff
• QA managers and personnel
• Regulatory affairs personnel
• Training department personnel
• Documentation department personnel
• Validation specialists
Kelly Thomas (25+ year exp.)
Vice President, Americas Quality Operations at Stallergenes Greer - Charlotte Metro USA
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.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.