Fri Apr 6, 9:00 AM - Sat Apr 7, 6:00 PM

The DoubleTree Baltimore-BWI Airport

890 Elkridge Landing Road - Linthicum, MD 21090, Linthicum, MD 21090

Community: Chelsea

Description

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.

Event Details

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.

Why you should attend:
"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.

Areas Covered in the Session:
An overview of global compliance issues, global harmonization initiatives, role of ICH, relevance of Validation activities & the Paradigm Shift
Quality Control and Quality Assurance i

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