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A Strategic Approach for Timely Market Entry

A Strategic Approach for Timely Market Entry

A Strategic Approach for Timely Market Entry ...more

ISO13485 Certification ,GMP

November 12, 20245 min read

Your Australian Regulatory Compliance Specialists Supporting Therapeutic Goods Manufacturers

Your Australian Regulatory Compliance Specialists Supporting Therapeutic Goods Manufacturers

Quality Systems Now: Your Australian Regulatory Compliance Specialists Supporting Therapeutic Goods Manufacturers ...more

Therapeutic Goods Administration ,GMP

November 05, 20246 min read

Achieving Business Transformation through Regulatory Compliance

Achieving Business Transformation through Regulatory Compliance

Achieving Business Transformation through Regulatory Compliance: Key Strategies for Sustainable Growth ...more

Therapeutic Goods Administration ,Quality Culture &GMP

October 28, 20246 min read

Site Licensing & Accreditation: Ensuring Compliance

Site Licensing & Accreditation: Ensuring Compliance

Site Licensing & Accreditation: Ensuring Compliance Through GMP, ISO 13485, and ISO 17025 ...more

ISO13485 Certification ,GMP

October 14, 20246 min read

Product and Process Development in Pharmaceuticals and Medical Devices: Key Considerations

Product and Process Development in Pharmaceuticals and Medical Devices: Key Considerations

Product and Process Development in Pharmaceuticals and Medical Devices: Key Considerations ...more

Therapeutic Goods Administration ,Procedures and Policies &GMP

October 08, 20246 min read

Introducing the New GMP Induction Training by Quality Systems Now

Introducing the New GMP Induction Training by Quality Systems Now

Introducing the New GMP Induction Training by Quality Systems Now ...more

Quality Training ,GMP

October 01, 20246 min read

A Detailed Overview of Clinical Quality Management Systems (CQMS) in the Life Sciences Industry

A Detailed Overview of Clinical Quality Management Systems (CQMS) in the Life Sciences Industry

A Detailed Overview of Clinical Quality Management Systems (CQMS) in the Life Sciences Industry ...more

Therapeutic Goods Administration ,GMP &QMS

October 01, 20246 min read

Get a Free Compliance Readiness Assessment from Quality Systems Now

Get a Free Compliance Readiness Assessment from Quality Systems Now

Get a Free Compliance Readiness Assessment from Quality Systems Now ...more

ISO13485 Certification ,Quality Culture &GMP

September 23, 20244 min read

Free Webinar 26/09 on Compliance Success

Free Webinar 26/09 on Compliance Success

Upcoming Webinar 26/09: Master the Art of Influencing Top Management for Compliance Success ...more

Quality Culture ,Leadership Values &GMP

September 23, 20245 min read

Influencing Top Management for Compliance: How to Talk to Senior Leaders and Get Results

Influencing Top Management for Compliance: How to Talk to Senior Leaders and Get Results

Influencing Top Management for Compliance: How to Talk to Senior Leaders and Get Results ...more

Therapeutic Goods Administration ,Leadership Values &GMP

September 16, 202410 min read

Understanding eQMS in GMP

Understanding eQMS in GMP

Understanding eQMS in GMP ...more

GMP ,QMS

September 10, 20246 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

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

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

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 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

Comprehensive Training Options for You or Your Team

Comprehensive Training Options for You or Your Team

Continuous learning and development are essential for maintaining competitiveness and ensuring compliance with industry standards. ...more

Quality Culture ,Quality Training &GMP

June 09, 20245 min read

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