Assess Your Laboratory - Based on the FDA System Based Inspection
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
"John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System"
Quality Control Laboratory plays an important part role
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, quality metrics and product and test method lifecycle, the operation of the laboratory unit becomes more visible. The organization should have active programs in which the laboratory is routinely assessed for compliance with applicable regulations and standards.
Why should you attend?
Prior to the 1990s, FDA investigators did not spend much time the quality control laboratory. However, shortly before the turn of the century, the FDA realized that many laboratories were not adequately investigating out-of-specification (OOS) results. This brought more visibility to the laboratories and today, FDA observations in the laboratory are among the most frequent observations made during an FDA inspection. It is appropriate that the quality control laboratory, or an audit group within the organization, proactively audit the laboratory to assure compliance of laboratory operations. This webinar is intended to provide guidance on areas to audit and potential non-compliances to look for.
The following areas will be covered:
- Standards for the assessment of laboratories
- FDA System based inspection
- The audit process – what to look for
- The audit report
- Audit follow-up
Who will Benefit
- Method Development laboratory managers
- Quality Control laboratory managers
- Quality Assurance Managers
- Method Development chemists
- Quality Control chemists
- Internal auditors
Industries who can attend
This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.