Health conference and seminar in San José

The Veterinary Drug Approval Process and FDA Regulatory Oversight

Ref: 33202 10/20/2021 -> 10/22/2021 - 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 ...

The Veterinary Drug Approval Process and FDA Regulatory Oversight

Ref: 33291 10/20/2021 -> 10/22/2021 - 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 ...

SOP Writing, Training and Compliance in the Pharmaceutical Industry

Ref: 33292 10/25/2021 -> 10/26/2021 - San Jose ^US

Editorial Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can ...

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Ref: 33375 11/04/2021 -> 11/05/2021 - San Jose ^US

Editorial Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products, as few as fifteen ...

The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

Ref: 33376 Friday November 05th, 2021 - San Jose ^US

Editorial This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and ...

How to Implement the FDA SUPAC Guidance

Ref: 33352 Thursday November 18th, 2021 - San Jose ^US

Editorial This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval ...

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

Ref: 32540 02/03/2022 -> 02/04/2022 - 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 ...

Human Error Reduction in GMP Manufacturing

Ref: 33174 Thursday July 13th, 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 ...