Pre-Approval Inspection Readiness Training Course

Pre-Approval Inspection Readiness Training Course (T69) New Course!


Process development for both drug substance and drug product (which includes packaging/devices), preparing a regulatory submission, and process validation activities are essential to achieving technical and regulatory success for introduction of pharmaceutical products into the market and maintaining those products over their lifecycle. Evolving requirements create ongoing challenges for both regulatory and inspectional elements. This training course on the elements necessary to ensure readiness for pre-approval inspections provides strategy and tactics towards preparation than can be customized to individual organization requirements.

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What You Will Learn

  • The phases of clinical development and their connection to product development
  • Formulation and API development including options and risks for change during development: understanding patient needs, risk management, and how process elements coalesce into a control strategy which forms the basis of the process
  • The importance of scale up and technology transfer,
  • Strategies for developing and submitting dossiers and why ICH M4Q is important
  • Good and bad times to use a drug master file (DMF)
  • Best practices in lifecycle management and leveraging ICH Q12
  • Best practices for process validation, preparing for, getting through, and succeeding at the pre-approval inspection.
  • Current compliance trends and issues to be on the watch for.

Resources and Activities

  • Pre-Course Work Materials
  • Interactive Exercises
  • Learning Assessments

Course Modules

  • Overview of the Development Process and Timelines
  • Formulation Development
  • Scale-up and CMC Dossier Preparation and Submission
  • Validation/Preparation for PAI/Launch

Who Should Attend

  • This course is intended to be useful to anyone involved in process development or commercializing new products, and transfer of existing products to new facilities.
  • Professionals with development, technology transfer, process validation or quality responsibilities, including regulatory compliance associates, process development scientists, facilities engineers, validation and quality assurance specialists, manufacturing managers, and regulators.

Additional Course Details

Process development can involve the use of science- and risk-based principles or a more traditional (sometimes called “minimal”) parametric approach. It is important to understand the underlying current guidance, including ICH Q7, Q8, Q9, Q10, Q11, and Q12, along with current regional expectations for process validation in order to ensure success. This course provides a foundation in all of these, and uses examples to enhance understanding. Current industry challenges and real-world examples are discussed that allow industry and regulators to understand each other when dealing with regulatory questions and pre-approval inspection.

Master the approach of developing a control strategy and its articulation via a regulatory submission, and learn about and avoid the more challenging situations that arise during inspections.

Communities of Practice

This training course is of particular interest to existing and future members of the ISPE Process/Product Development Communities of Practice.

Daily Schedule and Pricing

This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information