Quality Expectations for Drugs and Biologics during Early Development: Phase 2
Instructor:
Steven S Kuwahara
Product ID: 701010
- Duration: 75 Min
There are certain quality-related activities that are expected when information is gathered for the CMC section of an application. The nature and extent of these activities depend on the form of the experimental studies during the different phases of clinical trials. This presentation will discuss the quality-related activities that are expected for Phase 2 products used in clinical studies. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for NDAs (or BLAs) will be discussed. The quality elements for CMCs that are needed for Phase 2 clinical studies will be presented.
Areas Covered in the seminar:
- The key guidance document that will help guide your thinking.
- Letting FDA help you in making your submission.
- What you need to do to prepare for Phase 2
- FDA guidance documents that help to tell you what to do.
- What to do about QC studies such as instrument qualification, method validation, and process validation.
- What do you need for the CMC section?
- Use of the Common Technical Document (CTD) to determine activities.
Who will benefit:
This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying levels of quality activities that accompany early stages of Product development.
- Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions
- QA/QC personnel who need to plan work
- R & D personnel who will contribute data to CMC sections
- Project managers for product development studies
- Quality systems auditors
- Consultants
Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . He has participated in the product development process for small molecule drugs and biologics, and has prepared or reviewed many CMC sections.
More Training By Experts
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- Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP
- Small GMP problems which cause the biggest enforcement headaches: how to tackle them
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