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ComplianceOnline - visiting card : 8 results

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Medical meetings - Medical educations

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Medical meetings, medical post graduate degree, medical colloquy, medical symposium, medical good practice guide, medical conference, medical training cycle, medical seminar, medical education, medical CME, medical clinical.
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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 ...

Conference & Seminar: Pharmacy

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 ...

Conference & Seminar: Pharmacy

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 ...

Conference & Seminar: Pharmacy

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

Ref: 33384 11/18/2021 -> 11/19/2021 - 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 its ...

Conference & Seminar: Pharmacy

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)

Ref: 33385 12/02/2021 -> 12/03/2021 - San Jose US

Editorial The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal ...

Conference & Seminar: Pharmacy

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 ...

Conference & Seminar: Pharmacy

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 ...

Conference & Seminar: Pharmacy

Solving Statistical Mysteries - What Does FDA Want?

Ref: 32051 Thursday July 20th, 2023 - Palo Alto US

Editorial This webinar provides some practical and useful answers to the question "What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?" FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an ...

Conference & Seminar: Pharmacy