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Course "A Risk Based Strategy for the Development & Validation of and Validation of Analytical Methods with a QbD Approach" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Following the initial development, the steps further continues thru optimization and subsequently to Validation, leading to the understanding of Validation Parameters and their generic definitions. Guidance from EP, USP, ICH Q2 (R)1, AOAC etc. will be discussed. The presentation continually builds on from a conceptual level to practical applications leading to data handling, Data Integrity, Validation Protocol and other documentation, vis-a-vis Regulatory requirements. Discussions provide extensive guidance for preparing Methods Validation Protocols for the various stages of regulatory submissions, e.g. IND, NDA, ANDA, PAI, CMC etc. Various aspects of Laboratory Controls (CGMP), QC procedures, SOPs that cover calibration, standardization, Qualification and Validation, will be included, along with statistical tools, SQC, SPC for processing and monitoring of analytical data. Strategies for the development Stability indicating assays will be touched along with a discussion on Methods Transfer, Spec setting, QC Batch Release, Potency Assays etc.
"For various Analytical and Test Methods, a goal oriented pathway with proper design prior to development activities will help build Quality into the Method from the inception (QbD) and Validation helps to demonstrate that the desired Method is Fit For The Purpose. A Risk based strategy is needed to Develop and apply them for their intended purpose during the entire Life Cycle of such Methods" This presentation follows a progressive, time tested structure over the duration of 2 Days with a Breakout session for 2andHalf Hours on the 2nd Day, which involves Group participation ,with real analytical problem solving and Method Development and generate an appropriate Validation schematics and the Validation Protocol.
(From ACS site) Learn the fundamentals of quality assurance, quality control, and analytical methods validation and how to improve your FDA, WHO and OECD regulatory compliance directives for analytical data submissions.
(Sections I & II)
(Sections III & IV)
(Sections VI & VII)
Review of Parameters, Axioms & General Practices
Class Breakout Discussion - Group Exercise
(Sections IX & X)
Senior Director, ValQual International
Shib Mookherjea is a globally acclaimed speaker and consultant and has extensive experience in R&D, quality assurance, and quality management and teaches Methods Development, Validation Procedures, and Conformity Assessment in the Analytical Laboratory; Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ); and the webcast Cleaning Validation and Compliance Issues for Pharma, Biotech and Medical Device Industries.
Location: Seattle, WA Date: June 4th & 5th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA
Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*
Register now and save $200. (Early Bird)
Until May 10, Early Bird Price: $1,295.00 From May 11 to June 02, Regular Price: $1,495.00
Sponsorship Program benefits for “Validation of Analytical Methods with a QbD Approach
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