Latest news with #GoodDistributionPractice
Yahoo
09-06-2025
- Business
- Yahoo
Pharmaceuticals and APIs Good Distribution Practices (GMP) Training Course: Maintain Quality and Integrity Throughout the Entire Supply Chain (ONLINE EVENT: July 9-10, 2025)
Ensure pharmaceutical integrity with a thorough understanding of Good Distribution Practice (GDP) standards. This expert-led training course helps pharmaceutical distributors navigate supply chain challenges, mitigate risks, and safeguard product quality. Gain insights into GDP compliance, counterfeit prevention, and cargo security. Completion grants CPD and a certificate. Dublin, June 09, 2025 (GLOBE NEWSWIRE) -- The "Good Distribution Practices of Pharmaceuticals and APIs Training Course" training has been added to offering. It is crucial that pharmaceutical products adhere not only to high-quality standards as per Good Manufacturing Practice but also maintain their quality and integrity throughout the entire supply chain, up to the patient. This training course addresses the imperative for pharmaceutical distributors to adhere to GDP guidelines meticulously. Participants will gain thorough understanding of the roles responsible for implementing these practices and the critical junctures within the supply chain where they are most crucial. Discussions will focus on practical strategies for maintaining the quality, potency, integrity, and identity of pharmaceutical products from raw materials through to final distribution, ensuring compliance and safeguarding patient safety. In today's pharmaceutical landscape, ensuring the safe and reliable distribution of medicinal products is more critical than ever. The complexities of the pharmaceutical supply chain, coupled with the rising threat of counterfeit drugs infiltrating legitimate channels, underscore the necessity for robust Good Distribution Practice (GDP) standards. Good Storage and Distribution Practices (GSP, GDP) are paramount throughout the life cycle of pharmaceutical products and Active Pharmaceutical Ingredients (APIs). European regulations state the importance of implementing quality systems, risk management principles, and clearly defined processes to safeguard pharmaceutical integrity. Pharmaceutical distributors must establish comprehensive quality systems that define roles, processes, and risk management strategies to mitigate these challenges effectively. Benefits of attending Gain a comprehensive understanding of international GDP guidelines and regulations Explore supply chain risks and effective mitigation strategies Identify causes and explore solutions for drug shortages Acquire knowledge on cargo security protocols Receive expert guidance on detecting and preventing counterfeit drugs in the supply chain Learn storage and transportation requirements for pharmaceutical products in alignment with current pharmacopoeias Understand risks associated with transporting temperature-sensitive pharmaceuticals Obtain detailed insights into equipment qualification for storage, transport, and distribution Who Should Attend: Responsible persons Quality assurance specialists Quality control officers Regulatory affairs professionals Engineers Supply chain managers Logistics coordinators Warehouse and distribution managers Contracted warehouse and distribution centre operators Certifications: CPD: 12 hours for your records Certificate of completion Key Topics Covered: Day 1 Introduction to GDP and supply chain What is GDP, GSP? Regulatory Guidelines GDP, GSP (EMA, PIC/S, MHRA, TGA, WHO, FDA, EU GMP Annex 11, 15), USP 1079 Industry APIC, IPEC, PDA, IATA, CEIV, ISPE, ASTM, Introduction to the pharmaceutical supply chain How to determine and mitigate the pharmaceutical supply chain risks? What are the main risks available? Should disaster recovery be a requirement? How to implement contingency planning & business continuity? Drug shortages and counterfeiting How to prevent drug shortages? How to detect counterfeiting in legal supply chain? How to manage fake medicines e.g. during the COVID-19 pandemic? Storage of pharmaceuticals and biologics What is the optimum storage condition for pharmaceuticals, biologicals? How to manage time & temperature sensitive pharmaceutical, biological products? What to do when planning to design a cold room? How to qualify warehouse and distribution equipment? What factors must be taken into consideration to execute a temperature mapping study? Developing a Validation Plan Considering areas at risk Developing a protocol Calibration of data loggers Studying duration of the mapping Determining the measuring range Good Documentation Practices Collecting Data Loggers Downloading data Analysing data (21 CFR Part 11, EU GMP Annex 11, GAMP5) Preparing mapping report How to avoid temperature mapping mistakes? Where to locate temperature mapping devices? How to handle temperature & humidity excursions? What is Mean kinetic Temperature (MKT)? Is it necessary for every temperature ranges? Is it globally accepted? Is humidity a mandatory requirement in warehouses and cold rooms? How to choose the best temperature monitoring device? Temperature mapping study Group exercise 1: Risk assessment application to the pharmaceutical supply chain Critique of format Critique of content Workshop: Risk assessment Breakout groups to review and suggest improvement in risk assessment. Group exercise 2: Temperature risk management Critique of format Critique of content Day 2 Active and passive systems How to choose active and passive temperature-controlled systems? Do you think that you know much about dry ice? Does it make sense to start with a Validation Master Plan? Lane qualification & cargo security considerations What is a route /lane qualification? What are the transportation risks? How to ensure security on the road? How is transport validation different from transport verification? What is the main purpose of cloud-based temperature monitoring? What are the pros and cons of road, sea, air transport? Determining air freight and ocean freight challenges GDP for pharmaceuticals Are they known? Are they followed? Are they enforced? GDP for Active Pharmaceutical Ingredients (APIs) Interpretation of API GDP requirements Responsibilities of involved parties What is new for API manufactures? Implementation status Compliance expectations from API manufacturers Data integrity and Good Documentation Practices Data Integrity for temperature-controlled pharmaceuticals Supplier and customer qualification How to qualify a third-party logistics service provider Are you looking for a partner or supplier? Selecting the best 3PLSP How to audit warehouses and 3PLSPs? Regulatory inspections and cases What do the regulatory inspectors expect to see during an inspection? Group exercise 1: Truck qualification plan Critique of format Critique of content Group exercise 2: How to switch from air to ocean transport Critique of format Critique of content Speakers: Mustafa Edik Independent GMP Consultant and Auditor After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry. He has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies. While he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC /S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines. He finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University - Ireland. He is the author of chapter 6 of the book published by PDA named "Good Distribution Practices" and he is preparing his latest book on 'GMP Audits' which will be published by Taylor & Francis in 2023. 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. 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
Business Journals
24-04-2025
- Business
- Business Journals
Eagle Life Science: Elevating Cold Chain Logistics in the Heart of Boston
In a city synonymous with biomedical innovation, logistics excellence is no longer a support function — it's a strategic imperative. That's where Eagle Life Science steps in. As a newly established division of Eagle Air Freight, Eagle Life Science is poised to become Boston's most trusted partner in GDP-certified, GxP-compliant logistics for the life sciences and biotech sectors. Backed by more than three decades of freight forwarding and supply chain experience, Eagle Air Freight has long been a name known for reliability, global reach, and white-glove customer service. Now, that legacy is evolving with a specialized focus on one of the most critical and complex sectors: life sciences. Eagle Life Science was launched to meet the growing demand for precision logistics solutions in Greater Boston's rapidly expanding biopharma ecosystem. From early-stage research labs to commercial manufacturing, life sciences companies need partners who understand the rigor of regulated transport and storage — where the margin for error is zero, and patient impact is real. 'Our clients are developing therapies that save lives. We see ourselves as an extension of their mission,' says Michael O'Brien, President of Eagle Life Science. 'That means having the infrastructure, compliance, and mindset to support them at every step of the journey.' Located in Boston, the division's flagship facility will include a high-capacity cold room, a GMP-ready cleanroom, and a purpose-built freezer farm offering storage at -20°C, 0°C, and +2°C to +8°C — all supported by 24/7 real-time temperature monitoring and GxP-compliant handling protocols. But Eagle Life Science is going beyond storage. By investing in automation, AI-driven risk management, and predictive maintenance, the company aims to deliver unmatched reliability and transparency — essential in a world where every sample, biologic, or investigational drug may represent years of research. Compliance is not an afterthought. It's embedded in the company's DNA. The facility is built to Good Distribution Practice (GDP) standards, with comprehensive GxP training for all staff, digital SOP management, and audit-readiness as a baseline — not a goal. The service offering is designed for flexibility, covering early-phase R&D shipments, clinical trial supply chain support, biologics distribution, and storage for advanced therapies. Whether working with nimble biotech startups or global pharma firms, Eagle Life Science offers scalable, high-touch solutions that adapt to evolving needs. What makes the company different isn't just infrastructure — it's intention. At a time when life sciences supply chains are increasingly complex and global, Eagle Life Science brings a rare combination of agility, specialization, and service that clients say feels more like a partnership than a transaction. As Boston continues to lead in cell and gene therapy, personalized medicine, and biologic innovation, the need for agile, regulatory-savvy logistics partners will only grow. Eagle Life Science is here to meet that need — with purpose, precision, and people who care.
