The Quality Control Laboratory plays an important part role in the production and release of a drug product regulated by the FDA. Inspectional observations of non-compliant laboratory operations are high on the list of most frequent regulatory observations. As the industry focuses more on the quality system and product and test method lifecycle, the operation of the laboratory unit becomes more visible. The laboratory should have active programs in which the laboratory is routinely assessed for compliance to applicable regulations and standards.
Quality Control Laboratories have been an important part of inspections since the mid 1980s. These laboratories are generally staffed by highly educated and trained personnel and equipped with sophisticated instrumentation. Inspections include scrutiny of method validations typically performed by the Method Development Laboratory. In order to the meet regulatory requirements and have appropriate internal controls the, laboratories must implement training and laboratory control systems which are defined in extensive procedures. The organization and the laboratory should have proactive programs which provide assurance that the laboratory is continually in compliance with regulations and internal procedures. The objective of this webinar is to identify areas that should be reviewed in an assessment of the laboratory.
Areas Covered in the Session :
Standards for the assessment of laboratories
FDA System based inspection
The audit process – what to look for
The audit report
Who Will Benefit:
Method Development laboratory managers
Quality Control laboratory managers
Quality Assurance Managers
Method Development chemists
Quality Control chemists
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.
In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has audited and consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.
Dr. Lanese focuses on training. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.
Organizer: Compliance Training Panel
1:00pm to 2:30pm
General Admission: $239.00
Thursday, June 14th
Tuesday, June 12th
Tuesday, June 5th