Workflow
ResearchAndMarkets.com
icon
Search documents
FDA Recalls Masterclass: Proactive Preparation and Post-Recall Compliance (ONLINE EVENT)
Globenewswire· 2026-01-16 09:03
Core Insights - The "FDA Recalls Masterclass" training aims to enhance recall management strategies and compliance with FDA regulations [1] - The course emphasizes the importance of identifying root causes of recalls and implementing corrective and preventive action programs to avoid future issues [2] - Effective recall management is crucial for maintaining a company's reputation and minimizing financial losses associated with recalls [3] Training Overview - The training will cover essential aspects of FDA recalls, including definitions, types (Class I, II, III), and the FDA's recall authority and policy [8] - Participants will learn how to manage recalls under FDA oversight, interact with FDA staff, and develop health risk determinations [9] - The agenda includes sessions on proactive recall readiness, risk-based planning, executing recalls, and post-recall actions [10] Target Audience - The training is designed for recall managers, quality assurance managers, regulatory affairs directors, risk and product liability managers, and manufacturers [9] - It is also relevant for healthcare institutions, nursing homes, and medical practice groups [9] Key Topics - The course will address building compliant recall plans, setting up cross-functional recall teams, and conducting mock recall exercises [11] - It will cover notification procedures, managing media communications, and ensuring compliance through effectiveness checks [11] - Participants will engage in discussions on common pitfalls and best practices in recall management [11]
GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries (ONLINE EVENT)
Globenewswire· 2026-01-16 09:02
Core Insights - The training course on GMP Auditing for Quality Assurance is designed to enhance auditing skills in the pharmaceutical industry, focusing on compliance with FDA regulations and quality standards [1][2] Group 1: Training Course Details - The GMP Auditing course will take place on January 28th - 29th, 2026, and aims to equip professionals with the necessary competencies for effective auditing [1] - The course includes a comprehensive overview of GMP regulatory frameworks, types of audits, and audit planning [5] - Participants will receive a certificate of participation, presentation slides, and free handouts on GMP Auditing [6] Group 2: Learning Objectives - Attendees will learn to evaluate audit findings, identify critical components for audit reports, and conduct audits using trails and checklists [6][10] - The course covers the importance of GMP in quality assurance and the role of auditing in compliance and risk management [6] - Key topics include internal audits, supplier audits, regulatory inspections, and developing effective audit plans [6][9] Group 3: Target Audience - The training is suitable for QA/QC professionals, regulatory compliance managers, manufacturing supervisors, GMP auditors, and anyone responsible for GMP compliance in pharmaceuticals, supplements, or food industries [6][7] Group 4: Expert Instructors - The course will be led by Kelly Thomas, who has over 20 years of experience in cGMP and quality systems within the pharmaceutical and medical device sectors [7][8] - Ms. Thomas's expertise includes validation processes, risk-based approaches, and managing complex projects [8]
Supplier and Contract Manufacturer Management Training Course: Enhance Your Skills in Effectively Managing Supplier Relationships Throughout Their Lifecycle (ONLINE EVENT)
Globenewswire· 2026-01-16 09:01
Core Insights - The article announces a training course focused on supplier and contract manufacturer management, emphasizing compliance, qualification, and oversight [1][7]. Course Overview - The training course is scheduled for February 18th to 19th, 2026, and aims to enhance skills in managing supplier relationships throughout their lifecycle [1]. - It covers various aspects including supplier identification, qualification, risk management, continuous assessment, and exit planning [2]. Learning Objectives - Participants will learn about effective supplier management benefits and regulatory requirements [6]. - The course will provide strategies for supplier selection, quality agreement development, risk assessment, and performance monitoring [6][12]. Target Audience - The course is designed for professionals in supply chain management, quality assurance, regulatory compliance, manufacturing, procurement, and contract manufacturing [5][12]. - Specific roles that will benefit include Supply Chain Managers, Quality Assurance Professionals, Regulatory Affairs Managers, and Operations Managers [5][12]. Key Topics Covered - Day 1 includes sessions on regulatory requirements, the cost of poor quality, strategic management of suppliers, and risk management [8][10]. - Day 2 focuses on supplier qualification, relationship building, performance monitoring, and supplier assessments [11][18]. Additional Resources - Attendees will receive a copy of presentation slides and a certificate of training [6]. - The course includes practical exercises to create customized supplier scorecards and develop quality agreements [3][21].
EU Clinical Trial Regulation 536/2014: Compliance, Implementation & Best Practices Training (November 25, 2025)
Globenewswire· 2025-11-03 09:04
Core Insights - The training course on "EU Clinical Trial Regulation 536/2014" aims to provide comprehensive knowledge on compliance, implementation, and best practices for conducting clinical studies in the EU [1][2][4] Regulatory Framework - The course covers the requirements for conducting clinical studies under the EU Clinical Trial Regulation, including updates on EU-GCP and the new EU Pharmacovigilance Directive [2][3] - It discusses various licensing methods for Drugs, Biologics, and Combination Products, detailing the regulatory agencies' structure at the EU level and across Member States [3][4] Learning Objectives - Attendees will gain insights into the interaction between the EU and individual countries, registration procedures, and the impact of regulations on product development strategies [4][6] - The course aims to equip participants with strategies for streamlining the registration application process and understanding the concerns of European regulatory personnel [6][8] Key Topics - The training includes sessions on the new EU Regulation 536/2014, risk management in drug development, and the clinical trials application process [7][9] - Specific topics also cover investigational medicinal products (IMPs) and required documentation for compliance [9] Target Audience - The course is designed for a diverse audience, including quality assurance professionals, regulatory affairs experts, clinical operations staff, and investigators [8][10] - It aims to provide practical knowledge for effective trial conduct, submission processes, and compliance considerations [8][11]
Global Regulatory Requirements for Drug Safety & Pharmacovigilance: Product Safety, Effective Risk Assessment, and Alignment with Evolving U.S., EU, and UK Regulatory Expectations (November 25, 2025)
Globenewswire· 2025-11-03 09:03
Core Insights - The training course titled "Global Regulatory Requirements for Drug Safety & Pharmacovigilance" is aimed at pharmaceutical and biologic companies in the US and EU, focusing on product safety regulatory requirements [1][2]. Group 1: Training Course Overview - The course is designed to help companies understand the latest compliance expectations in pharmacovigilance to maintain product marketability [2]. - It emphasizes the importance of having adequate systems and processes for safety reporting to avoid significant consequences, including product recalls [2]. Group 2: Learning Objectives - Participants will learn about the regulatory requirements for drug safety, including the US, EU, and UK frameworks, and specific details regarding EU GVP modules [6]. - The course will cover the contents of the Pharmacovigilance System Master File (PSMF) and the requirements for quality oversight of drug safety [6]. - Key topics include signal management regulations, UK QPPV responsibilities, and penalties for non-compliance [6][8]. Group 3: Target Audience - The training is relevant for nearly all individuals involved in drug development and marketing, including executives with legal responsibilities for drug safety [5][6]. Group 4: Instructor Profile - The course will be led by Steve Jolley, a subject matter expert with 37 years of experience in drug safety and pharmacovigilance, who has worked with over 300 clients globally [10][12].
Greece Social Commerce Market Databook 2025, with Focus on Tomigo, Greeks.Social, Broombids, Facebook and Instagram
GlobeNewswire News Room· 2025-06-09 11:31
Core Insights - The social commerce market in Greece is projected to grow by 11.9% annually, reaching approximately USD 2.94 billion in 2025, following a robust growth period from 2021 to 2024 with a CAGR of 17.4% [2] - The market is expected to continue its upward trajectory with a forecasted CAGR of 7.4% from 2025 to 2030, expanding from USD 2.63 billion in 2024 to around USD 4.21 billion by the end of 2030 [2] Market Dynamics - The report provides a comprehensive analysis of the social commerce sector in Greece, including over 50 KPIs that cover market size, growth dynamics, and market share statistics [3][4] - It breaks down market opportunities by various factors such as domestic vs cross-border sales, social platform types, payment methods, business models, consumer segments, and city types [4] Consumer Insights - The report offers insights into consumer behavior and retail spending dynamics, utilizing both value and volume KPIs to provide a detailed understanding of market dynamics [4][6] - It emphasizes the importance of understanding evolving consumer attitudes and behaviors to increase ROI and improve targeting strategies in the social commerce sector [6] Competitive Landscape - The report includes a snapshot of the competitive landscape within the social commerce sector, highlighting key players and their market shares in Greece [6][8] - It aims to assist companies in formulating strategies to gain market share by identifying growth categories and evaluating trends and risks unique to the market [6] Future Growth Segments - The report outlines future growth dynamics across various retail product categories, end-use consumer segments, devices, locations, and payment methods from 2021 to 2030 [7][9] - It also provides forecasts for social commerce market size and share by platforms and consumer demographics, enhancing strategic decision-making capabilities [8]
Airworthiness Safety Conference 2025: Hear from Experts in Safety Management, Next-gen Safety, and Remote Pilot Systems (London, United Kingdom - October 21, 2025)
GlobeNewswire News Room· 2025-06-05 09:18
Core Insights - The conference aims to redefine aviation safety standards and serves as a pivotal meeting point for industry professionals focused on enhancing safety measures and implementing innovative solutions in aviation [1][2] Group 1: Conference Overview - The event provides a unique opportunity for participants to engage with distinguished industry leaders and fellow professionals, fostering in-depth discussions and substantial networking opportunities [2] - The agenda covers critical topics shaping the future of aviation safety, including regulatory frameworks, industry trends, airworthiness, workforce development, safety culture, and global safety management systems [4][6] Group 2: Agenda Highlights - The conference features a structured agenda starting with registration and networking, followed by presentations from industry experts on various topics related to aviation safety [3][5] - Key sessions include insights from regulators, discussions on Part 21 compliance, methodologies for measuring airworthiness, and strategies for developing the next generation of safety professionals [4][5] - The agenda also addresses global safety management system challenges and advancements in remote piloting operations [4][6]
Hyperscale Data Centers and Strategic Partnerships Enhance Europe's GPU Market Resilience | Europe Data Center GPUs Market Analysis and Forecast, 2024-2034
GlobeNewswire News Room· 2025-05-30 08:09
Core Insights - The European data center GPUs market is expected to grow from $10.6 billion in 2024 to $82.2 billion by 2034, with a compound annual growth rate (CAGR) of 22.75% during the forecast period [1][7]. Market Drivers - The increasing demand for high-performance computing to support AI, deep learning, and big data analytics is a primary driver of the GPU market's growth in Europe [2][4]. - The rapid expansion of hyperscale data centers and strategic partnerships between GPU manufacturers and cloud providers are enhancing supply chain resilience and operational scalability [3]. - The rise of AI applications and the need for effective processing resources are propelling the adoption of GPUs in data centers [4][5]. Market Trends - There is a growing integration of AI and machine learning across various industries, leading to a surge in demand for GPU acceleration [9]. - The focus on green and energy-efficient data center operations is driving the development of more power-efficient GPU technologies [5][9]. - Continuous innovation in GPU architecture and performance is essential to meet the increasing data-intensive workloads [9]. Market Challenges - High operating expenses and complex system integration pose challenges to the market [6]. - Supply chain disruptions in the semiconductor industry are impacting GPU availability [9]. - The elevated power consumption and cooling requirements of GPU systems create additional operational hurdles [9].
Chile Social Commerce Market Intelligence Report 2025-2030 Featuring Facebook, Instagram, ESCAPESwithYOU, 360, and Fantastic
GlobeNewswire News Room· 2025-05-15 13:08
Core Insights - The Chile social commerce market is projected to grow by 16.1% annually, reaching USD 1.02 billion in 2025 [1] - The market experienced a robust growth from 2021 to 2024, with a CAGR of 24.5%, and is expected to continue growing at a CAGR of 11.4% from 2025 to 2030, reaching approximately USD 1.76 billion by the end of 2030 [2] Market Dynamics - The report provides insights into the Chile Ecommerce Industry and Social Commerce Industry market size and future growth dynamics from 2021 to 2030, segmented by key performance indicators [4] - It includes detailed market segmentation with over 50 KPIs, offering a comprehensive understanding of market dynamics [5] Consumer Insights - The report emphasizes the importance of understanding consumer behavior and attitudes, which are evolving, to increase ROI in the social commerce sector [5] - It highlights retail spending dynamics across various consumer segments within the social commerce sector [5] Competitive Landscape - The report offers a snapshot of the competitive landscape in the social commerce sector, detailing key players and their market share in Chile [5] - It aids in formulating strategies to gain market share by identifying growth categories and specific segments across the value chain [5] Product Categories - The social commerce market encompasses various product categories including Clothing & Footwear, Beauty and Personal Care, Food & Grocery, Appliances and Electronics, Home Improvement, Travel, Hospitality, B2B, B2C, and C2C [6] Payment Methods and Platforms - The report forecasts the social commerce market size by payment methods, including Credit Card, Debit Card, Bank Transfer, Prepaid Card, Digital & Mobile Wallet, Other Digital Payment, and Cash [7][9] - It also analyzes the market size by platforms and consumer demographics, providing insights into the evolving landscape of social commerce [8][9]
Saudi Arabia Foodservice Market Report and Company Analysis 2025-2033 Featuring Al Tazaj, AlAmar, ALBAIK, Americana Restaurants Int'l, Apparel, Fawaz Abdulaziz AlHokair, Galadari, Herfy, Kondu, LuLu
GlobeNewswire News Room· 2025-04-07 14:15
Core Insights - The Saudi Arabia foodservice market is projected to grow from US$ 26.61 billion in 2024 to US$ 51.64 billion by 2033, with a compound annual growth rate (CAGR) of 7.66% from 2025 to 2033 [2][21] - The growth is driven by an increase in restaurants, demographic changes, urbanization, and evolving consumer preferences towards diverse and health-conscious dining options [2][4][9] Market Dynamics Growth Drivers - The number of local and international brands entering the market has expanded food options, particularly in major cities like Riyadh, Jeddah, and Dhahran [3] - The influence of international cuisine trends and the rise of online food delivery services are significant factors in the industry's rapid growth [4] - The government's Vision 2030 plan is enhancing the tourism sector, which is expected to further boost the foodservice industry [5] - A young population, with 37% under 25, is increasingly seeking international cuisines and diverse dining experiences [6] - The tourism boom, with 93.5 million arrivals in 2022, has significantly impacted the foodservice sector, with tourism spending reaching USD 49.33 billion [8] Challenges - The foodservice industry faces challenges from fluctuating food prices and supply chain disruptions due to reliance on imports [16] - Increased reliance on delivery services necessitates investments in digital solutions and delivery infrastructure, raising operational costs [18][19] Key Trends - There is a growing interest in health-conscious eating, leading to restaurants offering healthier menu options [9][10] - The demand for culinary experiences driven by tourists is reshaping dining services, with a focus on upscale dining and cultural events [12][13] - The rise of online meal delivery services is transforming the foodservice landscape, with companies adapting to meet consumer preferences for convenience [14][15] Key Players - Notable companies in the Saudi foodservice market include Al Tazaj Fakeih, AlAmar Foods Company, and Americana Restaurants International PLC [20][24] Market Overview - The report covers various aspects of the foodservice market, including types of foodservice, outlet types, and regional analysis [22][26] - The forecast period for the market analysis is from 2024 to 2033, with detailed insights into market dynamics and competitive landscape [21][22]