Latest news with #CPD-certified
Yahoo
a day ago
- Business
- Yahoo
Life Science Supplier Qualification Best Practices Training Course: Strengthen Compliance and Quality Systems, Navigate Complex Supplier Qualification Processes (ONLINE EVENT: July 16-17, 2025)
Strengthen your pharmaceutical, biotech, and medical device quality systems through comprehensive supplier qualification and audits. Navigate regulatory demands with expert strategies and crucial resources, including SOPs, risk audit templates, and quality agreements. Enhance compliance and optimize performance with CPD-certified training. Best Practices for Supplier Qualification in Life Science Training Course Dublin, June 09, 2025 (GLOBE NEWSWIRE) -- The "Best Practices for Supplier Qualification in Life Science Training Course" training has been added to offering. This course equips participants with practical strategies to navigate complex supplier qualification processes, enhancing compliance, and optimizing quality management systems to meet stringent regulatory expectations. Conduct thorough supplier qualifications and audits to strengthen the quality systems of your pharmaceutical, biotechnology, and medical device manufacturing processes. Ensuring suppliers consistently meet quality requirements is paramount across all materials and services procured. Regulatory agencies such as FDA, EMA, MHRA, TGA, PIC/S, and ISO 13485 have intensified their focus on supplier qualification. The 2015 update of the EU GMP Guide notably emphasised supplier selection and qualification in Chapter 5, marking a significant regulatory shift. While supplier qualification may have been unfamiliar decades ago, it has now become integral to industry practices. Qualifying suppliers, especially those in regions like China and India, presents unique challenges, demanding additional responsibilities for both parties. Beyond audits, establishing effective "Quality Agreements" is essential. Prior to outsourcing, companies must define minimum product specification and user requirements to ensure compliance with GMP standards. Each product may necessitate specific evaluation criteria during initial technical visits to potential supplier, involving assessment of SOPs, Quality Management Systems, previous audits, organisational structure, and task distribution. Delegates will gain comprehensive strategies and insights into conducting rigorous supplier qualification and audits to enhance the quality systems across pharmaceutical, biotechnology, and medical device manufacturing processes. Bonus documents included: Supplier qualification questionaries (API, excipient, packaging material) Supplier evaluation matrix Risk-based supplier audits Quality Agreement Supplier qualification sample SOP FDA inspection findings, example warning letters, Form 483s Warehouse, logistics service provider qualification documents Benefits of attending Learn supplier source search criteria Understand key considerations in supplier selection Develop skills in preparing supplier pre-evaluation questionnaires Discuss strategies to overcome constraints in supplier audits Formulate effective performance evaluations for suppliers Gain insights into evaluating suppliers from different perspectives Witness exemplary practices in pharmaceutical and medical device industries, exceeding health authority and GMP expectations. Certifications: CPD: 12 hours for your records Certificate of completion Who Should Attend: Quality Assurance/Quality Control Specialists GMP Compliance Officers Validation Professionals Engineering Personnel Operation Staff Manufacturing Professionals Supply Chain Logistics Staff IT Personnel Purchasing Managers Key Topics Covered: Day 1 Supplier Qualification Introduction What is supplier qualification? Why should qualification be done, who requires/expects It? International guidelines and directives for supplier qualification Overview of legislation, health authority expectations International Trade Laws Is the ISO 9001 certificate only sufficient for supplier qualification? Why should the purchasing unit receive GMP training? What should be the scope of training? Quality Management System and supplier qualification What is change control? How should deviations be managed? How are complaints, recalls, and supplier qualification related? What is the role and importance of purchasing in supplier qualification? Can quality assurance, supplier, and purchasing cooperation be achieved? Sampling and test reduction What does reduced testing mean? What are the health authority expectations for reduced testing? What should be done before test reduction? Raw materials and service providers Should active pharmaceutical ingredients (APIs) and excipients be evaluated using the same method? How to qualify service providers? Medical device suppliers Medical device supplier qualification process (21 CFR Part 820, MDR, GHTF, ISO 9001, ISO 1497, ISO 13485) PIP breast implant scandal Flow of supplier qualification & documentation How does the relationship between audits and supplier qualification begin? Who performs qualification activities? How do we know who does what - Manufacturer or Distributor? How will we document our supplier qualification activities? What is the qualification cycle? Group exercise: Review of an existing supplier categorisation and evaluation study Critique of format Critique of content Workshop: Supplier categorisation & evaluation Breakout groups to review and suggest improvement in the selection of supplier categorisation and evaluations. Day 2 Supplier auditing Why are audits necessary and critical? Risk-based audit planning. To audit or not to audit? What should the frequency of supplier audits be? Different approaches to different suppliers Quality agreement preparation What are Quality Agreements and why are they needed? What should and should not be included in quality agreements? Tips for negotiating an agreement. How to troubleshoot common deficiencies? Who prepares and approves the quality agreement? / Roles - What are the responsibilities? Supply chain risk management How should unexpected incidents be managed? How to apply risk management in supply chain? Cases What to consider when purchasing from Asian countries? How to overcome cultural difference problems in purchasing from India and China? How should we audit in India and China? What are the most common quality deficiencies? What is the latest situation of the pharmaceutical market in India and China? (Legal Requirements, Authority Approaches) What are the GMP violations in China and India? What about audits in Europe and Latin America? Which documents are enough to make a company legal/illegal? Supply chain risk mitigation strategies. Supplier qualification and digital technologies Group exercise: Review of an existing supplier Quality Agreement Critique of format Critique of content Workshop: Supplier Quality Agreement Breakout groups to review and suggest improvement in supplier quality agreements. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Best Practices for Supplier Qualification in Life Science Training Course CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 days ago
- Business
- Yahoo
Life Science Supplier Qualification Best Practices Training Course: Strengthen Compliance and Quality Systems, Navigate Complex Supplier Qualification Processes (ONLINE EVENT: July 16-17, 2025)
Strengthen your pharmaceutical, biotech, and medical device quality systems through comprehensive supplier qualification and audits. Navigate regulatory demands with expert strategies and crucial resources, including SOPs, risk audit templates, and quality agreements. Enhance compliance and optimize performance with CPD-certified training. Best Practices for Supplier Qualification in Life Science Training Course Dublin, June 09, 2025 (GLOBE NEWSWIRE) -- The "Best Practices for Supplier Qualification in Life Science Training Course" training has been added to offering. This course equips participants with practical strategies to navigate complex supplier qualification processes, enhancing compliance, and optimizing quality management systems to meet stringent regulatory expectations. Conduct thorough supplier qualifications and audits to strengthen the quality systems of your pharmaceutical, biotechnology, and medical device manufacturing processes. Ensuring suppliers consistently meet quality requirements is paramount across all materials and services procured. Regulatory agencies such as FDA, EMA, MHRA, TGA, PIC/S, and ISO 13485 have intensified their focus on supplier qualification. The 2015 update of the EU GMP Guide notably emphasised supplier selection and qualification in Chapter 5, marking a significant regulatory shift. While supplier qualification may have been unfamiliar decades ago, it has now become integral to industry practices. Qualifying suppliers, especially those in regions like China and India, presents unique challenges, demanding additional responsibilities for both parties. Beyond audits, establishing effective "Quality Agreements" is essential. Prior to outsourcing, companies must define minimum product specification and user requirements to ensure compliance with GMP standards. Each product may necessitate specific evaluation criteria during initial technical visits to potential supplier, involving assessment of SOPs, Quality Management Systems, previous audits, organisational structure, and task distribution. Delegates will gain comprehensive strategies and insights into conducting rigorous supplier qualification and audits to enhance the quality systems across pharmaceutical, biotechnology, and medical device manufacturing processes. Bonus documents included: Supplier qualification questionaries (API, excipient, packaging material) Supplier evaluation matrix Risk-based supplier audits Quality Agreement Supplier qualification sample SOP FDA inspection findings, example warning letters, Form 483s Warehouse, logistics service provider qualification documents Benefits of attending Learn supplier source search criteria Understand key considerations in supplier selection Develop skills in preparing supplier pre-evaluation questionnaires Discuss strategies to overcome constraints in supplier audits Formulate effective performance evaluations for suppliers Gain insights into evaluating suppliers from different perspectives Witness exemplary practices in pharmaceutical and medical device industries, exceeding health authority and GMP expectations. Certifications: CPD: 12 hours for your records Certificate of completion Who Should Attend: Quality Assurance/Quality Control Specialists GMP Compliance Officers Validation Professionals Engineering Personnel Operation Staff Manufacturing Professionals Supply Chain Logistics Staff IT Personnel Purchasing Managers Key Topics Covered: Day 1 Supplier Qualification Introduction What is supplier qualification? Why should qualification be done, who requires/expects It? International guidelines and directives for supplier qualification Overview of legislation, health authority expectations International Trade Laws Is the ISO 9001 certificate only sufficient for supplier qualification? Why should the purchasing unit receive GMP training? What should be the scope of training? Quality Management System and supplier qualification What is change control? How should deviations be managed? How are complaints, recalls, and supplier qualification related? What is the role and importance of purchasing in supplier qualification? Can quality assurance, supplier, and purchasing cooperation be achieved? Sampling and test reduction What does reduced testing mean? What are the health authority expectations for reduced testing? What should be done before test reduction? Raw materials and service providers Should active pharmaceutical ingredients (APIs) and excipients be evaluated using the same method? How to qualify service providers? Medical device suppliers Medical device supplier qualification process (21 CFR Part 820, MDR, GHTF, ISO 9001, ISO 1497, ISO 13485) PIP breast implant scandal Flow of supplier qualification & documentation How does the relationship between audits and supplier qualification begin? Who performs qualification activities? How do we know who does what - Manufacturer or Distributor? How will we document our supplier qualification activities? What is the qualification cycle? Group exercise: Review of an existing supplier categorisation and evaluation study Critique of format Critique of content Workshop: Supplier categorisation & evaluation Breakout groups to review and suggest improvement in the selection of supplier categorisation and evaluations. Day 2 Supplier auditing Why are audits necessary and critical? Risk-based audit planning. To audit or not to audit? What should the frequency of supplier audits be? Different approaches to different suppliers Quality agreement preparation What are Quality Agreements and why are they needed? What should and should not be included in quality agreements? Tips for negotiating an agreement. How to troubleshoot common deficiencies? Who prepares and approves the quality agreement? / Roles - What are the responsibilities? Supply chain risk management How should unexpected incidents be managed? How to apply risk management in supply chain? Cases What to consider when purchasing from Asian countries? How to overcome cultural difference problems in purchasing from India and China? How should we audit in India and China? What are the most common quality deficiencies? What is the latest situation of the pharmaceutical market in India and China? (Legal Requirements, Authority Approaches) What are the GMP violations in China and India? What about audits in Europe and Latin America? Which documents are enough to make a company legal/illegal? Supply chain risk mitigation strategies. Supplier qualification and digital technologies Group exercise: Review of an existing supplier Quality Agreement Critique of format Critique of content Workshop: Supplier Quality Agreement Breakout groups to review and suggest improvement in supplier quality agreements. For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Best Practices for Supplier Qualification in Life Science Training Course CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
Mid East Info
25-05-2025
- Business
- Mid East Info
Ministry of Transport and Logistic Services, Ministry of Investment, Matarat, Mobily, Red Sea Global headline Saudi Warehousing & Logistics Summit 2025
Over 30 speakers lead strategic conversations around seven core themes, including ESG, customer centricity and the impact of generative AI Running alongside Saudi Warehousing & Logistics Expo, the CPD-certified summit will feature expert-led sessions focused on empowering the next-generation workforce with forward-thinking industry strategies As Saudi Arabia strengthens its position as a global logistics hub, Saudi Warehousing & Logistics Expo returns to the Riyadh International Convention & Exhibition Center (RICEC) from 27–29 May 2025. Taking place under the patronage of the Ministry of Transport and Logistic Services, the event plays a central role in supporting the Kingdom's logistics transformation. With the sector projected to reach $15 billion by 2030, the expo provides a timely platform for stakeholders to align priorities, explore new solutions and contribute to national development objectives under Vision 2030 (Source: Ministry of Transport and Logistic Services). A focus on resilience, efficiency and future readiness Forming a central part of the exhibition is Saudi Warehousing & Logistics Summit, returning for its second edition. The CPD-certified programme brings together public and private sector leaders and service providers to engage in constructive dialogue, share practical insights and address the sector's evolving needs. In line with the ambitions of the National Industrial Development & Logistics Program (NIDLP) to position the Kingdom as a global logistics hub, the summit offers a strategic platform to align on priorities and support the growth of a sustainable, agile and internationally competitive logistics landscape. 'Saudi Warehousing & Logistics Summit returns as an essential meeting ground for leaders shaping the future of supply chain, warehousing and logistics in the Kingdom,' said Muhammed Kazi, Senior Vice President – Construction, dmg events. 'By bringing together a broad spectrum of voices, the summit plays a key role in guiding industry strategies aligned with Saudi Arabia's growth ambitions for the warehousing and logistics industry.' Discussing transformation, collaboration and ESG This year's summit agenda is built around seven key pillars: transformation, resilience, collaboration, generative AI, customer centricity and ESG. Speakers will explore practical approaches to streamlining operations, expanding warehousing capacity, building risk-resilient supply chains and adopting AI to meet rising customer and market expectations. With logistics playing an increasingly strategic role in economic diversification and trade facilitation, the summit will also highlight the need for stronger cross-industry collaboration and investment in talent. 'Saudi Warehousing & Logistics Summit creates space for strategic and data-driven engagement across sectors. I look forward to sharing the stage with fellow industry leaders to address real challenges, share success stories and insights and develop a shared understanding of what's needed to move forward,' said one of the key speakers at the summit, Ali Hakami, Chief Supply Chain & Procurement Officer at Hana Water. The speaker line-up features senior leaders and decision-makers from across the ecosystem, including Mutasim Al-Olayan, Strategic Planning Director, Ministry of Transport and Logistic Services; Alaa Banbelh, Director of New Logistics Program, Ministry of Transport and Logistic Services; Hala H. Alhuraibi, Aviation and Logistics Director, Ministry of Investment; Abdullah Munif AlMunif, Vice President for Commercial Business, Saudi Ports Authority; Sami Almoghirah, Logistics Director, Special Integrated Logistics Zone Company; Adeel Abdullah A Alsharif, Director of Materials & Logistics, Tahakom; and Wouter Nijland, Master Planning and Development Director, Matarat, among others. A dedicated case study will be delivered by Michael Stockdale, Group Head of Supply Chain and Logistics, Red Sea Global, highlighting the application of strategic supply chain design and sustainability principles. One of the sessions, 'Ensuring Future Readiness: Building an Efficient and Resilient Supply Chain,' will prioritize discussions on striking the right balance between performance and cost in a resilient and efficient supply chain. Running alongside Saudi Warehousing & Logistics Expo, Saudi Warehousing & Logistics Summit highlights the Kingdom's focus on logistics as a key enabler of economic growth and trade connectivity, contributing directly to Vision 2030 outcomes. Visitor registration for the free-to-attend event remains open at . Entry is restricted to visitors aged 18 and above.
