ISPE offering online learning course on USFDA GMP

by Madjackfrost on February 22, 2010

ISPE website logo

As I am newsletter subscriber for ISPE website, I will get website updates now and then. Today I got one newsletter from them and I find it might ring your bells because they offer GMP of Inspection Approach for Facilities and Equipment (based on USFDA regualtions). The learning objective are quite interesting. The following is the list of them.

Learning Objectives
  • Explain equipment verification, usage, and storage requirements
  • Identify what authority regarding equipment is provided to pharmaceutical companies in the GMP regulations
  • Describe what the acronyms WASP and COP stand for
  • Identify the purpose of equipment cleaning and sanitation and GMP log book requirements
  • Recognize the GMP calibration requirements
  • Explain the GMP preventive maintenance requirements
  • List the three types of Change Control
  • Identify the GMP training requirements
  • Identify the general regulations regarding facility design, construction and maintenance
  • Describe how location, design, and construction contribute to the quality of the product
  • Name the external factors that can impact your facility design
  • Describe the procedures and controls designed to ensure product quality
  • List the methods used to prevent cross-contamination

- source : ISPE website.

They are charging very little money for the course. If u have the resources to spend I suggest you to go for it.

For further details go here http://www.ispe.org/gmpFacilitiesandEquip

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