MRO Magazine

3-hr Virtual Seminar: Validation of Analytical Procedures and USP 1225: What You Need to Know to be Compliant – Research and Markets


June 16, 2016
By Business Wire News

DUBLIN

Research and Markets has announced the addition of the “3-hr Virtual Seminar: Validation of Analytical Procedures and USP 1225: What You Need to Know to be Compliant” webinar to their offering.

Validation testing and procedures provide the backbone of the analytical testing quality assurance program. By completing a robust validation analysis testing for analytical procedures provides the customers, clients and patients of drug products the assurance that the basic testing parameters and results are true and accurate.

Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various validation requirements. For USP and compendial testing, according to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards and must be followed.

The Current Good Manufacturing Practice regulations require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. According to these regulations, users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.

Course Objective:

– To identify which facilities, personnel and analytical methods that are impacted by validation under USP 1225

– Become familiar with the different types of validation protocols and testing requirements for common analytical testing

– Identify and become familiar with the new harmonization efforts and impact

– Implementing and maintaining a Quality environment (QA recommendations)

– Familiarization with different testing protocols and how they impact product, raw material and in process testing results

– How to formulate a validation protocol and different sections required for compliance

– HPLC, UPLC, Compendial USP and basic assay testing validations and verifications commonly used and how to organize testing

– Common areas of non-compliance and how to avoid these areas

– Basic overview of training requirements and review of validation protocol procedures

Target Audience:

– Biotechnology manufacturing personnel and support staff in the biotechnology/pharmaceutical technology industries

– Quality Assurance personnel and support staff in the biotechnology/pharmaceutical technology industries

– Quality Control laboratory personnel and support staff in the biotechnology/pharmaceutical technology industries

– Finished product and medical device testing and manufacturing facilities

– Environmental Monitoring Program manager and support staff in the biotechnology/pharmaceutical technology industries

– Pharmaceutical and general contract laboratory companies/entities who perform USP and analytical testing

– General laboratory personnel and staff who do routine work in an analytical testing laboratory

Course Outline:

– Types and examples of validation protocol testing and USP 1225

– Classifications and examples of USP assays and general compendial verification procedures and how to identify what you need

– Personnel training and evaluation recommendations

– QA program for validation review and approval along with specifications commonly used and examples

– Areas for validation activities and applicable regulations

– Common errors found in validation testing and protocol design

– List of products and testing requirements per USP 1225

– Basic overview of how to put together a robust validation protocol and testing from conception to approval

For more information visit http://www.researchandmarkets.com/research/7m3qvt/3hr_virtual

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
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Sector: Production and Quality Management , Pharmaceutical Manufacturing