Quality Expectations for Product Development CMC Activities: R & D, GLP or GMP
Instructor:
Steven S Kuwahara
Product ID: 700949
- 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 submission that is planned, and their variation is especially marked when considering submissions to perform experimental studies during the different phases of clinical trials. This presentation will discuss the quality-related activities that are expected for different stages of the product development process. Emphasis will be placed on the transition into full GMP work as clinical trials proceed, but the requirements for DMFs and NDAs (or BLAs) will be discussed. The quality elements for CMCs that are common to all types and stages of submissions will be discussed.
Areas Covered in the seminar:
- Which regulations come into play at different stages of product development.
- What to do at early stages.
- Varying levels of GMP stringency.
- Letting FDA help you in making your submission.
- Use of the Common Technical Document (CTD) to determine activities.
- 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?
- What are the common elements?
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 different stages of Product development.
- Regulatory Affairs personnel who coordinated 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.
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