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Webinar on “Auditing Analytical Laboratories for FDA Compliance” from GlobalCompliancePanel

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(Free Press Release) Owing to the heavy dose of preparation needed for it, auditing analytical laboratories is often intricate and difficult. One of the aspects that make it so is that not all GMP rules apply to the laboratory. Additionally, there may be extra requirements, depending upon the type of testing that is being conducted.

Webinar on “Auditing Analytical Laboratories for FDA Compliance” from GlobalCompliancePanel


      

 

Description:

Owing to the heavy dose of preparation needed for it, auditing analytical laboratories is often intricate and difficult. One of the aspects that make it so is that not all GMP rules apply to the laboratory. Additionally, there may be extra requirements, depending upon the type of testing that is being conducted.

This makes the whole process so confusing that oftentimes, the lab itself may not be aware of which regulations to apply to the particular kind of testing it is doing at a point of time. This webinar will discuss the preparation the auditor needs to make in order to make the audit successful. One of the banes of auditing an analytical laboratory is documentation. This will be discussed at this session. It will make the auditor familiar with what needs to be looked for during the audit.

This session will cover the following areas:

o GMP regulations that apply to analytical laboratories

o Reviewing documentation

o Advance preparation for the audit

o Auditing styles and structures

o Equipment and laboratory instrument qualification.

o What to look for while doing a walk-through.

o Other regulations and standards, including ISO 17025

o Following through on the audit

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When:June 11, 10:00 AM PDT | 01:00 PM EDT

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By whom:

Steven S. Kuwahara, Ph.D., is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. After securing degrees in Biochemistry from Cornell and the University of Wisconsin, Steven started off as an Assistant Professor of Chemistry.

His testing skills were honed in the initial years of his career at the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here, he developed expertise in the testing of blood derivatives, viral and bacterial vaccines. His work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, and gene therapy vectors.

During an impressive career spanning over 30 years, Steven has applied his academic knowledge to quality control in the pharmaceutical industry. Steven has written several papers and book chapters, and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.

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For whom:

The webinar will benefit

o External and Internal Auditors

o Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups

o Supervisors and Analysts in Contract Testing Laboratories

o Personnel Responsible for Selecting Contract Testing Laboratories

o Consultants

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Duration: 90 minutes

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To enroll for this webinar, contact

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Ph: 800-447-9407

Fax: 302-288-6884

PR LINK: http://bit.ly/YYW435

 




Webinar on “Auditing Analytical Laboratories for FDA Compliance” from GlobalCompliancePanel

Source: Press Release

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