Auditing Analytical Laboratories for FDA Compliance

Why should you attend:
This webinar will provide direction to all regulated companies that need to maintain a compliant Analytical Testing Laboratory.

Auditing of an Analytical Laboratory can be difficult; because Good Laboratory Practice (GLP) Regulations described in 21 CFR 58 do not apply to testing materials for clinical trial samples or final/bulk pharmaceutical product samples.

CRF title 21 part 58 Good Laboratory Practices do not apply by the Scope and the Definition outlined in 21 CFR part 58. The regulations collectively known as Good Clinical Practices (21 CFR 50, 54, 56, 312, and 314) are silent on standards for laboratories supporting clinical trials.

Therefore you have to use a GXP program - which is when you take what is applicable from all the Predicate Rules. This would include an independent Quality Assurance (QA) Department charged with overseeing the laboratory’s compliance program, and for assuring the quality and integrity of the data generated by the laboratory.

QA should routinely review all data and documentation generated by the laboratory to assure that only accurate data is reported. This training will show how to implement a GXP program and how to audit this program.

Areas Covered in the seminar:

• Analytical Laboratory Programs:
• Document Control Program
• Training Program
• Out of Specification (OOS) Test Results Investigation Program Metrology Program and Validation Program (including Assay validation-all assays should be validated)
• Internal Auditing.
• Preparing the Laboratory for an Audit.
• Recording Data and Archiving Data.

Who will benefit:

• Managers
• Supervisors and Associates in the Pharmaceutical Industry that have daily responsibilities in Quality Assurance,the Anaytical Laboratory and Compliance

Instructor Profile:
Michelle Sceppa, is the Principal at MSceppa Consulting, an establish Consulting firm and is in its 13thth year in the Industry that specializes in quality systems for Pharmaceutical and Biotechnology interests. MSceppa Consulting has implemented and managed Preclinical, Clinical, and Manufacturing Quality Assurance Programs for numerous clients. As the lead auditor, MSceppa Consulting has conducted and managed more than 500 internal and external vendor audits for Drug and Biologic firms in the US and Europe. MSceppa Consulting is knowledgeable in the details of compliance with all U.S. Federal Regulations-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) for Drugs, Biologics and Medical Devices.

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