Latest News

How does the TGA regulate therapeutic goods?

How does the TGA regulate therapeutic goods?

How the TGA Regulates Therapeutic Goods in Australia ...more

Therapeutic Goods Administration

September 02, 20245 min read

QSN: Your Australian Regulatory Compliance Specialist in Medicinal Cannabis

QSN: Your Australian Regulatory Compliance Specialist in Medicinal Cannabis

The medicinal cannabis industry in Australia is burgeoning, driven by an increasing recognition of its therapeutic potential and a supportive regulatory framework. ...more

Therapeutic Goods Administration ,GMP

September 02, 20245 min read

Advancing Public Health: The TGA’s Strategic Vision for 2024-2025

Advancing Public Health: The TGA’s Strategic Vision for 2024-2025

Advancing Public Health: The TGA’s Strategic Vision for 2024-2025 ...more

News ,AI &Medtech

August 27, 20244 min read

Establishing Organisational Audit Preparedness

Establishing Organisational Audit Preparedness

Establishing Organisational Audit Preparedness pharmaceuticals and medical devices ...more

ISO13485 Certification ,Good Manufacturing Practices Quality Culture &QMS

August 27, 20245 min read

Free Video Short Training Courses

Free Video Short Training Courses

Leveraging Free Training for Quality Management: A Gateway to Excellence in the Life Sciences Industry ...more

Procedures and Policies ,Quality Training

August 23, 20245 min read

Difficulty in maintaining control over compliance with GMP or ISO13485?

Difficulty in maintaining control over compliance with GMP or ISO13485?

Difficulty in Maintaining Control Over Compliance with GMP or ISO 13485: A Comprehensive Analysis ...more

ISO13485 Certification ,ISO Recommendations &GMP

August 23, 20247 min read

Investment in Innovation: Balancing Compliance with Growth and Innovation

Investment in Innovation: Balancing Compliance with Growth and Innovation

Investment in Innovation: Balancing Compliance with Growth and Innovation ...more

Quality Culture ,GMP &QMS

August 23, 20247 min read

Gaining market access without the stress of failing audits

Gaining market access without the stress of failing audits

Gaining Market Access Without the Stress of Failing Audits: A Strategic Approach to Regulatory Compliance ...more

Procedures and Policies ,Quality Culture GMP &QMS

August 22, 20247 min read

QMS Fundamentals and How to Stay and Remain Compliant

QMS Fundamentals and How to Stay and Remain Compliant

QMS Fundamentals and How to Stay Compliant: A Comprehensive Bootcamp for Quality Management in Pharma, Medtech, and Biotech ...more

Good Manufacturing Practices ,GMP &QMS

August 22, 20245 min read

Implementing an Electronic Quality Management System (eQMS)

Implementing an Electronic Quality Management System (eQMS)

Implementing an Electronic Quality Management System (eQMS) ...more

Quality Culture ,QMS

August 01, 20245 min read

Process Development and Identification of Critical Process Parameters (CPPs)

Process Development and Identification of Critical Process Parameters (CPPs)

Process Development and Identification of Critical Process Parameters (CPPs) ...more

Procedures and Policies

August 01, 20244 min read

20% Off on Whole and Mini Courses

20% Off on Whole and Mini Courses

Last Chance, ! 20% Off on Whole and Mini Courses – Promo Ends August 6, 2024 ...more

Good Manufacturing Practices ,Quality Training

August 01, 20242 min read

Training Programs Coupled with QMS Development

Training Programs Coupled with QMS Development

Implementing training programs, coupled with QMS development. ...more

ISO13485 Certification ,Quality Training &GMP

July 18, 20245 min read

Site licensing or accreditation for Greenfield sites and New Ventures

Site licensing or accreditation for Greenfield sites and New Ventures

Site licensing or accreditation for Greenfield sites and New Ventures ...more

ISO13485 Certification ,Good Manufacturing Practices &GMP

July 18, 20246 min read

MedTech and Reprocessing of Reusable Medical Devices

MedTech and Reprocessing of Reusable Medical Devices

MedTech and Reprocessing of Reusable Medical Devices: AS 4187 and AS 5369 ...more

Quality Training ,Medtech &QMS

July 17, 20244 min read

The Australian Research and Development Tax Incentive: A Catalyst for Innovation in the Medical Industry

The Australian Research and Development Tax Incentive: A Catalyst for Innovation in the Medical Industry

The Australian Research and Development (R&D) Tax Incentive is a key governmental initiative designed to foster innovation and support businesses in their R&D endeavors. ...more

Good Manufacturing Practices ,Quality Culture &News

July 01, 20244 min read

Ensuring Compliance with Australian TGA Requirements in the Release for Supply Process

Ensuring Compliance with Australian TGA Requirements in the Release for Supply Process

Ensuring Compliance with Australian TGA Requirements in the Release for Supply Process ...more

Therapeutic Goods Administration ,Quality Training

June 30, 20244 min read

Streamline How Your Team Works

Streamline How Your Team Works

Therapeutic manufacturers and support companies in Australia face unique challenges that require specialized solutions to maintain competitiveness and meet industry standards. ...more

Quality Training ,GMP

June 30, 20243 min read

Implementing AI in Regulated Industries to Guarantee GMP Compliance – Is it Possible? Part 3. Can you use AI to Create QMS Documents?

Implementing AI in Regulated Industries to Guarantee GMP Compliance – Is it Possible? Part 3. Can you use AI to Create QMS Documents?

Explore the viability of using AI to generate QMS documents. Discussing industry challenges, time, skill requirements, and limitations of AI like ChatGPT, this post highlights the importance of valuin... ...more

GMP ,AI

June 28, 20243 min read

Implementing AI in Regulated Industries to Guarantee GMP Compliance – Is it Possible? Part 2. What is an AI Management System?

Implementing AI in Regulated Industries to Guarantee GMP Compliance – Is it Possible? Part 2. What is an AI Management System?

Discover ISO 42001:2023, the new standard for AI management systems, ensuring safety and compliance in production processes and products. This article covers GMP, compliance evidence, data management,... ...more

GMP ,AI

June 24, 20246 min read

Quality Management Systems in Support of Business as Usual (BAU)

Quality Management Systems in Support of Business as Usual (BAU)

QMS supports "Business As Usual" (BAU) by seamlessly integrating with various facets of business operations ...more

Good Manufacturing Practices ,Quality Culture &Quality Training

June 19, 20244 min read

Quality Systems Now: Leading Compliance and Quality Management Solutions

Quality Systems Now: Leading Compliance and Quality Management Solutions

With a team of industry and compliance specialists, QSN is dedicated to supporting businesses through the challenges and complexities of compliance projects. ...more

Good Manufacturing Practices ,Quality Training &GMP

June 19, 20243 min read

Good Manufacturing Practice (GMP) Made Simple for Therapeutic Manufacturers

Good Manufacturing Practice (GMP) Made Simple for Therapeutic Manufacturers

Good Manufacturing Practice (GMP) is a system designed to ensure products are consistently produced and controlled according to quality standards. ...more

Therapeutic Goods Administration ,Good Manufacturing Practices &GMP

June 12, 20245 min read

Quality and Compliance Services: Ensuring Excellence in Business Operations

Quality and Compliance Services: Ensuring Excellence in Business Operations

Whether your organization is undergoing a transformation, preparing for inspections, or simply aiming to improve daily operations, comprehensive quality and compliance services can provide the support... ...more

Good Manufacturing Practices ,Quality Training

June 10, 20244 min read