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Liste des conférences et séminaires santé à San José : 9 résultats

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Conférence et séminaire santé à San José

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The Drug Development Process from Concept to Market

Réf: 33038 Mardi 27 Juillet 2021 - San Jose US

Editorial This course is designed to cater for employees of pharmaceutical companies who would like an understanding of the drug development and regulatory approval process. The course starts by considering the global pharmaceutical market, important therapeutic areas and the roles of different ...

Conférence & Séminaire: Pharmacie

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Réf: 33198 25/08/2021 -> 26/08/2021 - San Jose US

Editorial 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 ...

Conférence & Séminaire: Pharmacie

Change Control Best Practices - Avoiding Unintended Consequences of Changes

Réf: 33199 16/09/2021 -> 17/09/2021 - San Jose US

Editorial 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, ...

Conférence & Séminaire: Pharmacie

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

Réf: 33200 16/09/2021 -> 17/09/2021 - San Jose US

Editorial   The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine ...

Conférence & Séminaire: Pharmacie

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Réf: 33201 16/09/2021 -> 17/09/2021 - San Jose US

Editorial 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 ...

Conférence & Séminaire: Pharmacie

Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing

Réf: 33203 29/09/2021 -> 30/09/2021 - San Jose US

Editorial The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA's findings of deficiencies concerning equipment validation indicate the agencies expect definitive evidence that the equipment ...

Conférence & Séminaire: Pharmacie

The Veterinary Drug Approval Process and FDA Regulatory Oversight

Réf: 33202 20/10/2021 -> 22/10/2021 - San Jose US

Editorial The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government ...

Conférence & Séminaire: Pharmacie

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

Réf: 32540 03/02/2022 -> 04/02/2022 - San Jose US

Editorial 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 ...

Conférence & Séminaire: Pharmacie

Human Error Reduction in GMP Manufacturing

Réf: 33174 Jeudi 13 Juillet 2023 - San Jose US

Editorial This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
  Objectives Understand human error: factors and causes. Understand the ...

Conférence & Séminaire: Pharmacie