Manufacturing

Substantial business benefits are emerging from industry when Quality by Design (QbD) principles are used for new and existing drug products yielding reduced operating costs, enabling significantly more efficient manufacturing processes and better positioning companies to meet increasing regulatory expectations. For example, the completion of ICH Guidelines, Q8 (R2): Pharmaceutical Development, Q9: Quality Risk Management and Q10: Pharmaceutical Quality System and the recent USFDA guidance on Process Validation contain recommendations for building and capturing process knowledge and understanding and establishing a strategy for process control during Stage 1, process design. There is evidence from 483s and warning letters that FDA....

Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified risks, and acceptance of residual risks. Figure 1: Overview of a typical quality risk management process. ICH Quality Risk Management, Q9 The application and the complexity of risk management tools....

Technology transfer (TT) includes knowledge transfer, science and risk-based principles including ICH Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods between development and manufacturing sites and contract manufacturing organizations (CMOs) has become increasingly important. This classroom course identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry and....

Current manufacturing challenges for OSD forms (tablets and capsules), that include Quality, Safety, and Productivity (QSP) continue to be paramount. This interactive course focuses on the quality controls, new technical advancements, production management and operational excellence for raw materials, processes and applications to improve manufacturing. This classroom course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and GMP inspection preparation, and provides guidance on advanced asset lifecycle management strategy. Using a Process and Production Video Simulation for Unit Ops, including Mixing, Blending, Drying, Sizing, Tableting, Encapsulating and Coating provides....

Operations are defined as the transformative process within a series of activities, along a value chain extending from supplier to customer. Operations Management designs, operates, and improves supply chain systems and provides the pharmaceutical industry with a knowledge base to promote the use of best practices and operational excellence within pharmaceutical operations management. This classroom course is designed to provide participants with a deep understanding of how to measure operational excellence including insights on relevant qualitative enablers as well as meaningful quantitative performance indicators. Using the well-established architecture of the St. Gallen OPEX Benchmarking, this course also leverages this well-established....

As regulations worldwide are moving to risk-based approaches to determine when shared facilities can be used, manufacturers need tools to help meet the new requirements. The tools include setting appropriate health-based limits, technical and organizational controls, risk management processes, and understanding how to pull it all together in a succinct package for regulators, auditors as well as senior management. When applied properly risk management processes can help reduce costs and increase efficiencies while maintaining patient safety and product quality. This is important as patients and regulators are pushing for lower cost medicines. The key is to understand your risk of....

Process analytical technology (PAT) is becoming a very important tool for controlling pharmaceutical processes and when implementing Quality by Design. As defined by the USFDA, PAT is "a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality." As a scientific, risk-based framework, PAT is intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance and is being seen as a very important tool for Quality by Design. The PAT framework is founded....

With the increasing regulatory scrutiny on combination products, this new highly interactive course provides six (6) different aspects of a combination product which are: Combination Product GMPs Criticality of Design Input and how to define the requirements Design Verification and Validation approaches What to expect and considerations for Clinical Trial for Combination Products Human Factors for Combination Products Post Market Considerations An overview and the intricacies of the GMPs for combination products will be provided that specifically address the challenges and expectations from industry and global regulatory agencies. The development of the basis for the product, testing, and specifications including....

CTM Managers continue to play a critical role in a company’s ability to efficiently bring life-saving products to market. Unfortunately in today’s high-pressure and time sensitive research environment, CTM Managers frequently learn while focusing on the specific requirements of an assigned trial, with less priority being given to the critical need for solid training in all aspects of CTM management. In this classroom course , you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the CTM....

Due to the growing pressures from global competitors, high marketing demands, and the requirements of GMP compliance, the bio-pharm industry (brand drugs and generic drug companies) are looking beyond the usual group of closely-knit suppliers. India and China engage in bulk activities and have been generating new dimensional API products with more specialized capabilities than those required by traditional drug products. In order to remain competitive, API manufacturers will need to attune themselves to this evolving dynamic global market. This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies....