Manufacturing

  • Quality Risk Management Workshop (T42)
    This highly interactive, 3 day advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.
  • Oral Solid Dosage Manufacturing Process Training Course (T10)
    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.
  • Implementing Process Analytical Technology Training Course (T29)
    This classroom course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.
  • Clinical Trial Materials Training Course (T13)
    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 and how to implement the plan and troubleshoot. The course will also cover the logistics of distribution of the CTM to the clinical sites globally. Important tools, such as outsourcing vendors for packaging and labeling and Interactive Response Technology will be covered to ensure familiarity with all the necessary concepts.
  • Combination Products: Challenges and Expectations Training Course (T47)
    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....
  • ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course (T30)
    This classroom course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.