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Training Programs Coupled with QMS Development

Training Programs Coupled with QMS Development

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

Quality Culture ,Quality Training

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

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

Therapeutic Goods Administration ,Quality Culture &Quality Training

July 17, 20246 min read

Food Safety Management and Compliance

Food Safety Management and Compliance

Food Safety Management - ISO 22000 / HACCP ...more

Therapeutic Goods Administration ,Food Safety

July 17, 20245 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

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

Accreditation and Commercialization Services: A Comprehensive Guide

Accreditation and Commercialization Services: A Comprehensive Guide

Accreditation and commercialization services are essential for companies aiming to achieve Good Manufacturing Practice (GMP) licenses and ISO certifications. These certifications are critical for ensu... ...more

Good Manufacturing Practices ,Quality Training

June 04, 20243 min read

Book Review: "Eliminating the Gobbledygook" by Kathy Walsh

Book Review: "Eliminating the Gobbledygook" by Kathy Walsh

by Kathy Walsh is a compelling exploration into the world of clear, concise, and effective communication ...more

Good Manufacturing Practices ,Procedures and Policies &Document Writing

June 02, 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

About ISO 19011 guidance for quality management systems (QMS)

About ISO 19011 guidance for quality management systems (QMS)

Released by the International Organization for Standardization (ISO), it provides guidelines for auditing management systems, regardless of the type of organization or the sector it operates in ...more

Good Manufacturing Practices ,Quality Training &ISO 19011

May 07, 20243 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

Working with the Therapeutic Goods Administration (TGA)

Working with the Therapeutic Goods Administration (TGA)

In Australia, the Therapeutic Goods Administration (TGA) oversees the quality, safety, and availability of therapeutic products. ...more

Therapeutic Goods Administration

April 25, 20244 min read