LATEST NEWS
Case Study: Establishing ISO 13485 and ISO 14971 Compliance
Case Study: Establishing ISO 13485 and ISO 14971 Compliance in a New Medical Device Manufacturing Facility ...more
ISO13485 Certification
September 23, 2025•5 min read
ISO 14971: Application of Risk Management to Medical Devices
ISO 14971: Application of Risk Management to Medical Devices ...more
Quality Culture ,GMP
September 21, 2025•6 min read
Australian Requirements for GMP Clean Rooms
Australian Requirements for GMP Clean Rooms ...more
Good Manufacturing Practices
September 16, 2025•5 min read
How Risk Impacts Medicine Supply in Australia
How Risk Impacts Medicine Supply in Australia ...more
Therapeutic Goods Administration ,Medtech
September 14, 2025•6 min read
Complying with ALCOA++ Principles
Complying with ALCOA++ Principles ...more
Quality Culture ,Compliance
September 10, 2025•6 min read
Navigating the Release for Supply (RFS) Process Effectively
Navigating the Release for Supply (RFS) Process Effectively ...more
GMP
September 07, 2025•6 min read
How to respond to a TGA Post Inspection Letter (PIL)
How to respond to a TGA Post Inspection Letter (PIL) ...more
Therapeutic Goods Administration ,Compliance
September 03, 2025•6 min read
Key Updates and Strategic Implications of the Draft EU GMP Chapter 4 Documentation
Key Updates and Strategic Implications of the Draft EU GMP Chapter 4 Documentation ...more
GMP
September 01, 2025•5 min read
What the New Chapter 4 Means for GMP Documentation
What the New Chapter 4 Means for GMP Documentation ...more
News ,GMP
August 27, 2025•4 min read
What the Revised Annex 11 Means for Computerised Systems in GMP
What the Revised Annex 11 Means for Computerised Systems in GMP ...more
GMP
August 25, 2025•4 min read
Updates on TGA Public Consultation for GMP Guidelines
Updates on TGA Public Consultation for GMP Guidelines: Ensuring Relevance in a Technologically Evolving Industry ...more
GMP
August 18, 2025•5 min read
TGA Review on AI Regulation Strengthening and Clarification
TGA Review on AI Regulation Strengthening and Clarification ...more
Therapeutic Goods Administration ,News
August 17, 2025•6 min read
Just Got Your Grant or Seed Funding? Don’t Spend It All on R&D
Just Got Your Grant or Seed Funding? Don’t Spend It All on R&D ...more
News ,GMP
August 11, 2025•5 min read
Ready For Inspections: Validating Lab Systems and Data
Ready For Inspections: Validating Lab Systems and Data ...more
Quality Culture ,QMS
August 10, 2025•5 min read
GMP Readiness Made Simple
GMP Readiness Made Simple ...more
Good Manufacturing Practices ,GMP
August 06, 2025•5 min read
Surviving the Compliance Cliff
Surviving the Compliance Cliff ...more
Compliance
August 03, 2025•5 min read
The Role of Documentation in GMP Compliance
The Role of Documentation in GMP Compliance ...more
Procedures and Policies ,Document Writing
July 30, 2025•5 min read
Cultural Excellence in Pharma
Cultural Excellence in Pharma ...more
Quality Culture
July 28, 2025•6 min read
Laboratory Systems, Equipment, Methods, and Specifications
Laboratory Systems, Equipment, Methods, and Specifications: Foundations of GMP Compliance and Product Quality ...more
GMP ,Compliance
July 23, 2025•6 min read
Boosting Quality Management Maturity
Boosting Quality Management Maturity ...more
Quality Culture ,QMS
July 21, 2025•6 min read
From Quality Culture to Business Success
From Quality Culture to Business Success ...more
Quality Culture
July 16, 2025•6 min read
ISO13485:2016 – Quality Management Systems for Regulatory Purposes
ISO13485:2016 – Quality Management Systems for Regulatory Purposes ...more
ISO13485 Certification
July 14, 2025•6 min read
Product Development Guidance
Product Development Guidance ...more
Good Manufacturing Practices ,Quality Culture
July 08, 2025•5 min read
How AI Will Replace Compliance Tasks
How AI Will Replace Compliance Tasks ...more
Compliance
July 06, 2025•5 min read