2024-04-24

Quality management systems (QMS) have historically been document- and event-driven, focused mainly on document management functions. Today's QMS solutions are changing in response to efforts to digitize manufacturing across industry sectors, including pharma. With 72% percent of life science manufacturing companies still reporting that a significant amount of their quality data is still in paper or flat file form, it’s clear more work still needs to be done industrywide to move closer to fully digitizing relevant data. In response, QMS providers are working to make their applications more data-focused than document-focused.

Key Takeaways

QMS plays a critical role in enabling review by exception (RBE) for pharma manufacturers. To achieve the aspirations of data-centricity and RBE, three capabilities are essential:

1. "System of Systems" interoperability to other enterprise systems and data sources that contain critical elements of the electronic batch record (EBR).

2. Access to or embedded Advanced Industrial Analytics capabilities across QMS and EBR for improved visibility into operational status, to enable automatic release, and more.

3. Enhanced configurability across manufacturing and quality departments that empowers them with increased flexibility and agility.

The QMS market is growing, and leading-edge providers are moving toward enabling RBE, enhanced visibility, and increased flexibility through their applications. A future where RBE is more the rule than the exception makes pharma manufacturers more agile and efficient, a necessary shift in today's economy.

2024-04-23

Traditional management review meetings, while crucial in life sciences, often find themselves in a data labyrinth. The challenge lies in accessing and integrating data from multiple systems, leading to inefficiencies and limited insights. Our webinar will focus on how modern data architecture, specifically a Quality Systems Management Review (QSMR) within a data fabric infrastructure, can be the key to unlocking these challenges. This integration can streamline processes, improve decision-making, and enhance efficiency across all levels of the organization.

In this session, we will delve into the practical application of a data fabric, demonstrating how it can create a flexible and responsive data ecosystem. We will also showcase examples of the integration of data fabric and QSMR, underlining the tangible benefits of enhanced data accessibility and quality on performance metrics.

The webinar offers attendees a unique opportunity to gain valuable insights that can propel their organization to new performance heights. It is a must-attend for those keen on staying ahead of the game and maximizing their organizational resources.

2024-04-16

Unlock the secrets to mastering CAPA writing. Our expert instructor will guide you through recognizing common writing pitfalls and adopting best practices for clear and compliant documentation. 

Throughout the webinar, you'll gain invaluable insights into navigating the complexities of CAPA writing with confidence. From understanding regulatory requirements to implementing effective communication strategies, you'll discover practical techniques to elevate your writing skills and ensure the effectiveness of your corrective and preventive actions. 

Learn how to:

• Communicate corrective actions precisely to secure regulatory compliance 

• Recognize and avoid typical CAPA writing problems 

• Structure comprehensive, actionable and compliant CAPAs 

• Spot the do's and don'ts of CAPA writing for clarity and efficacy 

• Identify missing components and understand successful CAPA criteria 

• Highlight key supplier/vendor issues to tackle supply chain challenges 

2024-03-26

Izmir, Türkiye

TECCHED Project website.

2024-02-21

Quality Digest Webinar

Join us for an engaging webinar session while we delve deep into mastering the audit process. From crafting powerful documentation to nailing opening and closing meetings, we've got your inspection success playbook covered.

Discover how to identify weaknesses, develop foolproof corrective action plans, and shift the focus from people to process. Elevate your skills with hands-on techniques, including objective evidence collection and dynamic interview strategies. Don't miss this opportunity to revolutionize your approach to inspections and audits!

• Master the intricacies of the audit process for heightened comprehension

• Acquire skills to pinpoint and rectify any weak spots efficiently

• Grasp the goals behind opening and closing meetings with precision

• Hone the art of analyzing and collecting objective evidence

• Shift focus from individuals to system processes for a holistic perspective

• Craft a comprehensive audit checklist for thorough assessments

• Harness effective interview techniques tailored for internal audits

2024-02-21

This webinar is organized by Advisera, and covers the following topics:

• Which document templates are included in the Documentation Toolkit, and what they look like

• How to fill out the documentation templates

• The sequence of writing the documents

• What additional support is included in the price of the Toolkit

• The most common problems in OH&S project and how to avoid them

The webinar is delivered by Mark Hammar, an ISO 45001 expert.

2024-02-09

Organized by the IRQB - the International Rail Quality Board.

The topics discussed are:

• ISO 22163:2023 Railway applications — Railway quality management system — ISO 9001:2015 and specific requirements for application in the railway sector

• IRIS Certification and Re-certification: Audit days citeria (Staff headcount and Turnover (million Euro)

• IRIS Portal

• IRIS Performance Assessment: 2024 Simplified Approach

• IRIS Performance Assessment: 2024 Quality Performance Level: Maturity Model (Maturity Levels: Optimized: 4 pts / Qualified: 3 points  / Defined: 2 points / Simplified: 1,5 points / Poor: 1 point / Insufficient: 0 points)

• A new Audit Tool (a web application) is about to be made available for purchase.

2024-02-06

Suppliers face increasing pressure from customers today to maintain more and more certifications to various new and existing standards. This not only increases complexity but can add to resource and documentation costs, not to mention adding multiple required audits throughout the year. Migrating to an Integrated Management System is the smart way to integrate processes and simultaneously mitigate risk while gaining efficiency improvements through integrated risks and audits.

Product Development and manufacturing have evolved through changes in standards, changes in customer requirements, increased product complexity, changes to a remote workforce, highly distributed global supply chains, and various compliance requirements. However, using a digitalized platform can help most organizations unify and simplify their Quality Process. Death by Excel, email, and standalone silo systems is a common scenario. Omnex's EwQIMS® (Integrated Management System) can help digitalize your Business and Quality Processes to ensure effective collaboration, create online process maps, scale, improve decision-making, and "Data" the new electricity to fuel prediction and analysis.

Join this webinar to learn more about our comprehensive EwQIMS® Platform and how it can help your organization to digitalize and integrate your requirements and processes into a single tool providing tremendous savings and efficiency for the organization.

2024-01-30

The business world is evolving at lightning speed, fueled by cutting-edge technology and AI integration. To truly thrive, standing out and satisfying customers demands a holistic approach. Enter Total Quality Management (TQM), a concept as valid today as it was in the mid 80s when it was introduced.

Back in the day, management was thought to merely oversee quality. TQM changed that game. It's a cross-industry philosophy zeroed in on customer satisfaction and continual improvement. TQM embeds quality into operations, involving every team member in the pursuit of excellence. Key principles? Think leadership commitment, employee involvement, data-driven decisions and relentless progress. 

This webinar will focus on TQM’s core principles reshaping organizational operations. We’ll dive deep into quality planning, control, improvement, staff training, and customer feedback, unveiling benefits like cost reduction and turbocharged customer satisfaction. 

Yet, implementing TQM isn’t easy. We'll conquer challenges—breaking resistance, optimizing resources, defining key metrics, and igniting that crucial cultural shift. 

Key Takeaways:  

• Understanding the principles of TQM

• Obstacles putting TQM into practice 

• Creating a TQM culture

• A roadmap for operational excellence and continuous improvement

24 January 2024

Организатор: Сдружение “Клуб 9000”

Участниците в уебинара ще могат да планират и да се подготвят за промените през 2024 г. и 2025 г. в системите за управление на качеството и за докладване на информация във връзка с устойчивостта.

Съдържание

• Въведение.

• Основни изисквания на ESG директивата за отчитане на устойчивостта.

• Цели за устойчиво развитие на ООН.

• Преглед на изискванията на Система за управление на качеството в съответствие със стандарта БДС ISO 9001:2015 от гледна точка на ЕSG директивата.

• Нови изисквания за Система за управление на качеството (ISO 9001:2015 Amd 1:2024).

• Бъдещи промени през 2025 г. в изискванията на ISO 9001 за СУК.

• Докладване на информация във връзка с устойчивостта.

• Заключение.

Лектор: н.с. I ст. инж. Митко Мирчев

https://club9000.org/esg-%d0%b8-%d0%bf%d1%80%d0%be%d0%bc%d0%b5%d0%bd%d0%b8-%d0%b2-%d0%b8%d0%b7%d0%b8%d1%81%d0%ba%d0%b2%d0%b0%d0%bd%d0%b8%d1%8f%d1%82%d0%b0-%d0%bd%d0%b0-iso-9001-%d0%bf%d1%80%d0%b5%d0%b7-2024-%d0%b8-2025-i/ 

19 January 2024

An Innovation in Action Series

Description: Many think that creativity is some kind of magic but in truth we all possess creativity. The challenge is ‘how do we unleash it?’ Contrary to popular belief creativity has a framework although that framework is quite loose. Creativity needs an initial stimulant, but the results of creativity will be wide and diverse and need to be narrowed down to working solutions.

Learning Objectives: 

• How Creativity is initiated

• Primary attributes of creative people

• How to develop creative attributes in yourself

Presenter: Peter Merrill is a Keynote Speaker on Innovation and has keynoted at conferences in cities such as Dubai, Mumbai and Shanghai. He began his career in R&D in a major UK corporation and later as Chief Executive of a leading Design Brand in that corporation he led Innovation in one of the most demanding markets. He is one of North America’s foremost authorities on Management Systems which he has implemented in such innovative companies as IBM, A.I.G., and BlackBerry. He was founding chair of the ASQ Innovation Division and currently is a member of the Board of Directors of ASQ. He is international project lead on ISO 56001 the new auditable innovation standard. He is author of the books “Innovation Generation”, “Innovation Never Stops”, and his most recent book is “ISO 56000, Building Innovation into your QMS.