AnQual workshop: Validation and qualification of methods and analytical system in a regulatory laboratory Event as iCalendar

28 February 2013 - 01 March 2013

9am - 5pm

Venue: Marion Davis Library and Lecture Centre, Auckland Hospital

A goal-oriented methods development will be introduced with a generic, iterative and modular approach to understand validation of analytical methods in general with a special emphasis on HPLC, LC-MS and other separation science methods. The guidance from USP, ICH, AOAC and other international standards will be discussed with great emphasis on submissions to FDA, EMEA and other regulatory agencies.

This workshop also gives a conceptual background of the qualification and validation of various instruments, systems and equipment from a risk assessment and product lifecycle perspective with several examples, specifications, protocols, MVP and SOP requirements at various stages (IQ, OQ, PQ) of deployment and use of various equipment, instruments etc. Examples are discussed with acceptance criteria, particularly with lab systems and their QC/QA perspectives.

If you’d like to improve your skills in method development and understand the requirements and implementation of validation and qualification, this course is for you.

The workshop aims to develop concepts about method validation with a fundamental scientific approach, as well as to understand the basic approach to the qualification of various instruments/systems that are used across most laboratories. With the QbD and the more fundamental approach of measurement, errors and uncertainties in the analytical measurement process are emphasized during the entire workshop.

Dr Shib Mookherjea

is an internationally acclaimed speaker and consultant. He has extensive experience in R&D, quality assurance, and quality management. During the past 25 years, he has held both senior scientist and management positions within the R&D, QA and regulatory areas with companies such as Johnson and Johnson, Colgate-Palmolive, BASF, and Troy Corporation/Troy Biosciences, CROs and governmental

organizations. He is a recognized expert in the fields of validation, QA, and QC in both the pharmaceutical and process industries.

To register go to

www.sepscience.com/Information/Events/Workshops/1326-/Validation-and-Qualification-of-Methods-and-Analytical-System-in-a-Regulatory-Laboratory-New-Zealand