Conférences - Législation en médecine et pharmacologie - États-Unis

Complianceonline

One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely impact products, processes, equipment, facilities, etc. A single inadequate change may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate changes may require costly and time-consuming system remediation efforts.

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Complianceonline

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

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FDA cGMP guidelines, FDA cGMP compliance audits, FDA cGMP audit, FDA audit training, FDA audit preparation, good manufacturing practices compliance, FDA regulations compliance, cGMP for FDA regulated companies, cGMP, Current Good Manufacturing Practices

Complianceonline

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection. The types of micro-organisms, typical mitigation steps in ensuring an effective contamination control through Personnel Training (Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures),Gowning Controls, Personnel Training, Cleanroom Trafficking (Cleanroom Personnel Material, Product and Equipment Transfer Practices and Training (Entry and Exit Policy), Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program and the Basics of Sterilization Processes- Physical and Chemical Processes will also be discussed. The various regulatory bodies’ requirements such as 21 CFR Part 211 (mostly relevant 211.113 “Control of microbiological contamination”, ISO 14644 (Various Parts), FDA Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing - Current Good Manufacturing Practice”) amongst others and the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products are important to the quality determination and release of the finished manufactured products.

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Cleanroom regulations, Cleanroom classifications, Cleanroom design considerations, Cleanroom qualification, Cleanroom cleaning validation IOQ/PQ, Cleanroom Routine Monitoring and Excursion Investigation, Cleanroom Environmental Monitoring Program, Environmental Monitoring Program, Cleanroom Monitoring, Excursion Investigation and Trending of Data, Cleanroom Personnel Training, Aseptic Practices, Cleanroom Behavior and Contamination Control Procedures, Cleanroom Trafficking, Cleanroom Gowning, Contamination Control, Cleaning and Disinfection Program, Sterilization Processes- Physical and Chemical Processes, basic concept of microbiology, microbiological and contamination control practices

Complianceonline

The globalization of the pharmaceutical supply chain has resulted in the increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it also presents unique compliance risks, particularly since operations are not under your direct control. Compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious cGMP compliance and data integrity issues at foreign CMO sites.

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