Conférences - Législation en médecine et pharmacologie - États-Unis

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1
Change Control Best Practices - Avoiding Unintended Consequences of Changes
28 jan 2021 - 29 jan 2021 • SanJose – virtual, États-Unis
Organisateur:
Complianceonline
Résumé:
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.
Contact:
Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com
Sujets:
change control process, change execution plan, fda change control expectations, change control best practices, change control procedure fda, fda guidance change control, fda management of change, fda document control, change control practices avoiding unintended consequences
Identifiant de l'évènement:
1394589
Sujets apparentés:
2
Structuring and Conducting Risk-Based Internal cGMP Compliance Audits
03 fév 2021 • SanJose – online, États-Unis
Organisateur:
Complianceonline
Résumé:
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.
Contact:
Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com
Sujets:
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
Identifiant de l'évènement:
1393602
3
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
03 fév 2021 - 04 fév 2021 • SanJose, États-Unis
Organisateur:
Complianceonline
Résumé:
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.
Contact:
Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com
Sujets:
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
Identifiant de l'évènement:
1397572
4
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
16 fév 2021 - 17 fév 2021 • SanJose, États-Unis
Organisateur:
Complianceonline
Résumé:
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.
Contact:
Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com
Sujets:
pharmaceutical contract laboratories, pharmaceutical contract manufacturers in usa, contract drug manufacturers, pharmaceutical contract companies, contract drug manufacturing companies, pharma contract manufacturers, pharmaceutical contract manufacturing companies, outsourcing in pharmaceutical industry, american pharmaceutical outsourcing, pharmaceutical manufacturing industry, pharmaceutical outsourcing trends, pharmaceutical outsourcing companies, pharmaceutical manufacturing process, pharmaceutical contract manufacturing services, CMO Oversight in Pharma Industry, CMO compliance, CMO business model, CMO Qualification Audit, CMO operations, CMO records, CMO situations, CMO audits
Identifiant de l'évènement:
1397626


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Dernière mise à jour: 20 Décembre 2020