Small GMP problems which cause the biggest enforcement headaches: how to tackle them

There are a number of GMP issues that are often considered to be minor issues or are difficult to detect if the inspector is inexperienced. Several of these issues have led to major GMP problems. The presentation will use examples taken from warning letters to illustrate some of these problems, and discuss possible solutions. As an example, we will discuss the process for accepting raw material. Different companies follow various procedures, some of which are not acceptable and lead to major problems for the company.

Areas Covered in the seminar:

• The need for periodic quality reviews within a company and of its suppliers.
• Preventing bad habits.
• Monitoring the warning letters.
• Controlling raw material.
• Environmental Control
• Qualification processes.
• Avoiding blind spots and minimizing critical requirements due to ignorance.

Who will benefit:

This presentation will be aimed at QA and QC personnel who must monitor company activities and prevent the development of "blind spots.".

• Manufacturing and Regulatory personnel who must cooperate with Quality personnel.
• Managers of different operational departments.
• Project Managers.
• Consultants.

Instructor Profile:

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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