1-2 JULY 2019
With optional half-day shortsession on:
cGMP Updates in Sterile Products: Auditing, Inspection and Trends
3 JULY 2019
Course topics include:
Principles of designing stable sterile formulation
Formulations of Proteins, Antibodies, Antibody-Drug Conjugates
Sterile manufacturing and quality control
Auditing and inspection
• Understand the types of sterile products and their different requirements.
• Become aware of the current and future topics affecting sterile product development and manufacturing.
• Understand how excipients are used to stabilize small and large molecule formulations.
• Learn differences in formulation components and processing for solutions, dispersed systems and lyophilized formulations.
• Learn the basics for aseptic manufacturing in a cGMP environment and become familiar with unit operations required for different products.
• Consider the testing needed for quality control of sterile products.
• Understand the influence of packaging materials on the stability of the formulations and the ease of manufacturing.
• Evaluate current trends in cGMP inspections and discuss how they are related to regulations.
• Consider approaches to auditing in a cGMP environment and how to respond to questions.
Who should attend
The course is intended for people specifically interested or involved in parenteral products development, manufacturing , QA and QC. Details are provided to aid attendees in applying the information, and becoming aware of the key aspects to address during sterile products development and manufacturing. Attendees may include project managers, technical services and operations, quality assurance, product development.
The 2 days course introduces to sterile products development, manufacturing, and quality assurance. The first day focuses on formulation and process development of solutions, dispersed systems, and freeze-dried products, with emphasis on development of biomolecules, supported byspecific case studies. Parenteral manufacturing operations, quality control testing, and packaging are thoroughly discussed in the second day. The optional, half-day short course discusses the most recent trends on cGMP regulations, quality auditing, and considerations for responses to
See Course Brochure in the Attachment
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