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Search for: Pharmaceutical and Medical Device Regulatory Affairs

Drug Delivery Systems for Metabolic Disorders - Product Thumbnail Image

Drug Delivery Systems for Metabolic Disorders

  • Book
  • August 2022
Powerful Closed-loop CAPA - Meeting FDA Expectations - Product Thumbnail Image

Powerful Closed-loop CAPA - Meeting FDA Expectations

  • Training
  • 90 Minutes
  • Global
Basic Cleanroom Technology, Operation and Contamination Control in a Nutshell - Product Thumbnail Image

Basic Cleanroom Technology, Operation and Contamination Control in a Nutshell

  • Training
  • 90 Minutes
  • Global
Project Management for FDA-Regulated Companies - Product Thumbnail Image

Project Management for FDA-Regulated Companies

  • Training
  • 90 Minutes
  • Global
OTC Drug Regulations - Product Thumbnail Image

OTC Drug Regulations

  • Training
  • 60 Minutes
  • Global
The FDA Inspection Process: From SOP to 483 - Product Thumbnail Image

The FDA Inspection Process: From SOP to 483

  • Training
  • 60 Minutes
  • Global
Establishing a Robust Supplier Management Program - Product Thumbnail Image

Establishing a Robust Supplier Management Program

  • Training
  • 90 Minutes
  • Global
CDISC Mapping 2: ODM, MindMaps and References - Product Thumbnail Image

CDISC Mapping 2: ODM, MindMaps and References

  • Training
  • 90 Minutes
  • Global
How to Prepare a Standard Operating Procedure (SOP)? - Product Thumbnail Image

How to Prepare a Standard Operating Procedure (SOP)?

  • Training
  • 60 Minutes
  • Global
Combination Drug/Device Products CGMPs - Final Rule - Product Thumbnail Image

Combination Drug/Device Products CGMPs - Final Rule

  • Training
  • 90 Minutes
  • Global
Hazard Analysis and Risk Management under ISO 14971:2007/2012 - Product Thumbnail Image

Hazard Analysis and Risk Management under ISO 14971:2007/2012

  • Training
  • 60 Minutes
  • Global
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes - Product Thumbnail Image

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Training
  • 90 Minutes
  • Global
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities - Product Thumbnail Image

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Training
  • 90 Minutes
  • Global
Software Validation and its 11 Key Documents - Product Thumbnail Image

Software Validation and its 11 Key Documents

  • Training
  • 90 Minutes
  • Global
Trial Registration and Results Reporting on ClinicalTrials.gov - Product Thumbnail Image

Trial Registration and Results Reporting on ClinicalTrials.gov

  • Training
  • 60 Minutes
  • Global
Validation Master Plan - The Unwritten Requirements - Product Thumbnail Image

Validation Master Plan - The Unwritten Requirements

  • Training
  • 60 Minutes
  • Global
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention - Product Thumbnail Image

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

  • Training
  • 60 Minutes
  • Global
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments - Product Thumbnail Image

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

  • Training
  • 75 Minutes
  • Global
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents - Product Thumbnail Image

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

  • Training
  • 90 Minutes
  • Global
Computer System Validation: Step-by-Step - Product Thumbnail Image

Computer System Validation: Step-by-Step

  • Training
  • 75 Minutes
  • Global
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