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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

ISO 17025: Ensuring Competence in Testing and Calibration Laboratories

ISO 17025: Ensuring Competence in Testing and Calibration Laboratories

ISO 17025 is an international standard that specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. ...more

Good Manufacturing Practices ,GMP

June 08, 20244 min read

Understanding ISO 13485: Ensuring Quality in Medical Device Manufacturing

Understanding ISO 13485: Ensuring Quality in Medical Device Manufacturing

ISO 13485 is an international standard that outlines the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices. ...more

ISO13485 Certification ,ISO Recommendations &GMP

June 05, 20244 min read

Implementing AI in Regulated Industries to Guarantee GMP Compliance – Is it Possible?   Part 1. What are the Regulators saying?

Implementing AI in Regulated Industries to Guarantee GMP Compliance – Is it Possible? Part 1. What are the Regulators saying?

Artificial Intelligence – it’s causing a lot of discussions at the moment! But does it have a place in regulated industries like pharmaceuticals, medical devices or biotech to provide faster diagnoses... ...more

GMP

May 20, 20245 min read

Free Training: Secrets to Getting Your Team to Write User-Friendly Documents

Free Training: Secrets to Getting Your Team to Write User-Friendly Documents

Participation in this training is entirely free. All you need to do is register using the link provided below. ...more

Document Writing ,GMP

May 07, 20242 min read

What is Good Manufacturing Practice (GMP)?

What is Good Manufacturing Practice (GMP)?

Good Manufacturing Practice (GMP) outlines a series of principles and procedures aimed at guaranteeing the high quality of therapeutic goods when implemented. ...more

Good Manufacturing Practices ,Quality Culture &GMP

May 07, 20242 min read

Writing Procedures According to ISO or GMP Standards

Writing Procedures According to ISO or GMP Standards

Writing policies and procedures in accordance with ISO standards necessitates a systematic approach to ensure compliance, clarity, and efficacy. ...more

Good Manufacturing Practices ,Procedures and Policies Quality Training &GMP

April 29, 20243 min read

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