qualified person training module 1

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Are you a Qualified Person? Or a (young) professional in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control, Quality Assurance or Regulatory Affairs? Dealing with complex quality systems?

During these four days of training, you will explore the role and responsibilities of the Qualified Person in the pharmaceutical industry and hospital pharmacy.

Why follow this training?

This four-day training provides insight into an integrated approach on quality management as a good business practice in the pharmaceutical, biotechnological, medical device industries, and hospitals to safeguard their products’ quality. During the training, there will be a focus on the Qualified Person (QP) role and responsibilities, as well on international legislation, guidelines, and best practices. We will also discuss common challenges a QP encounters in day-to-day activities.
You will participate in a team to work out a case study in the period between the first and second course sessions.

After having followed this course, you will have:

  • Insight into the integrated approach on Quality Management to safeguard product quality.
  • Tools to realize and improve, pro-actively and on an ongoing basis, effective quality management across the various stages of the product lifecycle.
  • Thorough understanding of the specific regulatory responsibilities of senior management, functional leaders, the Qualified Person and Responsible Person.

The following subjects will be discussed during the training:

  • Quality Management as a good business practice across the product life-cycle
  • Basic Principles of Quality Management
  • The specific regulatory role and responsibility of Senior Management, the Qualified Person and the Responsible Person
  • Quality Management System elements: deviation management, change control, validation & qualification, training and qualification of personnel, customer complaint management, audit systems, third party operations including risk management and data integrity
  • Trending, and management reviews
  • Lean Manufacturing and Quality Management
  • Similarities and differences between local (small) organizations and global (large) organizations
  • Current regulatory developments and inspection highlights
  • Inspection Readiness: How to manage a regulatory GMP inspection
  • The critical impact of culture and behavior on compliance
  • QP experiences
  • Industry, hospital environment, international setting
  • Real-life challenge

About the author

julian.koster@pcs-nl.com

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