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Results for tag: "GMP"

Master Validation Plan - The Unwritten Requirements (Recorded) - Product Thumbnail Image

Master Validation Plan - The Unwritten Requirements (Recorded)

  • Training
  • July 2024
  • 3 Hours
  • Global
From
GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers (Recorded) - Product Thumbnail Image

GMP Auditing of Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers (Recorded)

  • Training
  • March 2024
  • 6 Hours
  • Global
From
The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers (Recorded) - Product Thumbnail Image

The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers (Recorded)

  • Training
  • February 2024
  • 2 Days
  • Global
From
The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 (Recorded) - Product Thumbnail Image

The US FDA QMSR Transition - 21 CFR 820 and ISO 13485 (Recorded)

  • Training
  • February 2024
  • 90 Minutes
  • United States
From
OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements (Recorded) - Product Thumbnail Image

OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements (Recorded)

  • Training
  • September 2023
  • 2 Days
  • Global
From
Enhancing Quality Oversight in Pharmaceutical Contract Manufacturing Organizations (Recorded) - Product Thumbnail Image

Enhancing Quality Oversight in Pharmaceutical Contract Manufacturing Organizations (Recorded)

  • Training
  • August 2023
  • 2 Days
  • Global
From
The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future (Recorded) - Product Thumbnail Image

The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future (Recorded)

  • Training
  • June 2023
  • 1 Hour
  • Europe
From
6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities - Webinar (Recorded) - Product Thumbnail Image

6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities - Webinar (Recorded)

  • Webinar
  • February 2023
  • 360 Minutes
  • Global
From
Europe - Pharmaceuticals, Major Manufacturers Map - 5th Edition - Product Thumbnail Image

Europe - Pharmaceuticals, Major Manufacturers Map - 5th Edition

  • Map
  • November 2022
  • Europe
From
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies (Recorded) - Product Thumbnail Image

Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies (Recorded)

  • Training
  • May 2021
  • 2 Days
  • Global
From
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation) - Product Thumbnail Image

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

  • Training
  • Global
From
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (Recorded) - Product Thumbnail Image

cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (Recorded)

  • Training
  • March 2025
  • 3 Hours
  • Global
From
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (Recorded) - Product Thumbnail Image

cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA (Recorded)

  • Training
  • November 2024
  • 1 Day
  • Global
From
Annual Current Good Manufacturing Practices (cGMP) Training (Recorded) - Product Thumbnail Image

Annual Current Good Manufacturing Practices (cGMP) Training (Recorded)

  • Training
  • June 2024
  • 60 Minutes
  • Global
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance (Recorded) - Product Thumbnail Image

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance (Recorded)

  • Training
  • June 2024
  • 90 Minutes
  • Global
Annual GMP Master Class 2024 (Recorded) - Product Thumbnail Image

Annual GMP Master Class 2024 (Recorded)

  • Training
  • March 2024
  • 2 Days
  • Global
From
A TO Z OF Analytical Method Validation, Verification and Transfer (Recorded) - Product Thumbnail Image

A TO Z OF Analytical Method Validation, Verification and Transfer (Recorded)

  • Training
  • March 2024
  • 2 Days
  • Global
From
Good Clinical Practices (GCP) Audit and Inspection Readiness (Recorded) - Product Thumbnail Image

Good Clinical Practices (GCP) Audit and Inspection Readiness (Recorded)

  • Training
  • March 2024
  • 90 Minutes
  • Global
From
eCTD Submissions - Fundamentals and Process (Recorded) - Product Thumbnail Image

eCTD Submissions - Fundamentals and Process (Recorded)

  • Training
  • February 2024
  • 60 Minutes
  • Global
From
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations - Webinar (Recorded) - Product Thumbnail Image

GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations - Webinar (Recorded)

  • Webinar
  • February 2024
  • 90 Minutes
  • Global
From
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Good Manufacturing Practice (GMP) is a set of regulations and guidelines that govern the production of pharmaceuticals. GMP is designed to ensure that pharmaceuticals are consistently produced and controlled according to quality standards. It is intended to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Compliance with GMP is mandatory for all manufacturers of pharmaceuticals and active pharmaceutical ingredients. The GMP market is composed of companies that provide services and products related to GMP compliance. These services and products include consulting, auditing, training, and software solutions. Companies in the GMP market include Parexel, SGS, Eurofins, and NSF International. Show Less Read more