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ComplianceOnline

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Themes :
Bio-Technologies, Pharmacy

Upcoming events


SOP Writing, Training and Compliance in the Pharmaceutical Industry

Réf: 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 ...

Conference & Seminar: Pharmacy

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

Réf: 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

Réf: 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

Réf: 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

Réf: 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)

Réf: 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

Réf: 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

Réf: 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?

Réf: 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

Past events


The Veterinary Drug Approval Process and FDA Regulatory Oversight

Réf: 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 ...

Conference & Seminar: Pharmacy

The Veterinary Drug Approval Process and FDA Regulatory Oversight

Réf: 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 ...

Conference & Seminar: Pharmacy

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

Réf: 33290 10/07/2021 -> 10/08/2021 - San Jose US

Editorial The objective of this on-line, interactive two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn their current and updated status and to confirm that those Chapters being utilized are used correctly. USP documents that ...

Conference & Seminar: Pharmacy

Designing and Sustaining New and Existing Product Stability Testing Program

Réf: 33289 10/06/2021 -> 10/07/2021 - San Jose US

Editorial New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, some manufacturers of new drug ...

Conference & Seminar: Pharmacy

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

Réf: 33203 09/29/2021 -> 09/30/2021 - 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 ...

Conference & Seminar: Pharmacy

Method Development and Validation for Assays Supporting Testing of Biologics

Réf: 33288 09/22/2021 -> 09/23/2021 - San Jose US

Editorial Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This 2-day virtual seminar is ...

Conference & Seminar: Pharmacy

Change Control Best Practices - Avoiding Unintended Consequences of Changes

Réf: 33199 09/16/2021 -> 09/17/2021 - 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, ...

Conference & Seminar: Pharmacy

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

Réf: 33200 09/16/2021 -> 09/17/2021 - 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 ...

Conference & Seminar: Pharmacy

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

Réf: 33201 09/16/2021 -> 09/17/2021 - 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 ...

Conference & Seminar: Pharmacy

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Réf: 33198 08/25/2021 -> 08/26/2021 - 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 ...

Conference & Seminar: Pharmacy

The Drug Development Process from Concept to Market

Réf: 33038 Tuesday July 27th, 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 ...

Conference & Seminar: Pharmacy

Pharmaceutical Data Integrity

Réf: 33176 Monday July 19th, 2021 - San Jose US

Editorial Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in ...

Conference & Seminar: Pharmacy

Data Integrity: FDA/EMA Requirements and Implementation

Réf: 33037 07/14/2021 -> 07/15/2021 - San Jose US

Editorial The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities ...

Conference & Seminar: Pharmacy

Human Error Reduction in GMP Manufacturing

Réf: 33014 Tuesday July 13th, 2021 - 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 importance: ...

Conference & Seminar: Pharmacy

Investigation of Out-of-Specification Test Results

Réf: 33175 Tuesday July 13th, 2021 - San jose US

Editorial Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.
  Objectives What does FDA say? Retesting: testing into compliance. Resampling: when can it be done; when not. Averaging: do’s and ...

Conference & Seminar: Pharmacy

Method Development and Validation for Assays Supporting Testing of Biologics

Réf: 32959 06/24/2021 -> 06/25/2021 - San Jose US

Editorial Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This 2-day virtual seminar is ...

Conference & Seminar: Pharmacy