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USFDA GMP Inspection Approach for Facilities and Equipment
USFDA GMP Inspection Approach for Facilities and Equipment
USFDA GMP Inspection Approach for Facilities and Equipment
This highly interactive pre-recorded online course reviews the Facilities and Equipment Systems and their importance within the USFDA Systems Inspection. The Facilities System elements examine the general regulations regarding facility design, maintenance and construction; minimizing risks and preventing cross-contamination to protect the quality of the product. Review the design elements and process controls which permit effective cleaning and maintenance, minimize the build-up of dirt and dust, and prevent quality defects. The Equipment System elements reviewed include general requirements for equipment and equipment design, usage and storage; the regulations that cover the purpose, methods and procedures for equipment cleaning and sanitation; change control; equipment log book requirements and exceptions covered in the GMP regulations; calibration and maintenance, and the importance of training and recognizing the GMP training requirements.

The course includes pre- and post-assessments, a downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all Web links discussed. At the conclusion of this session, participants will be able to:

  • 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

Developer Biography

James C. Gerner, Ed.D, M.S., M.T. (ASCP). Dr. Gerner is qualified by sixteen years of experience as an independent consultant in the Food, Pharmaceutical, Biotech, Biopharm, Clinical Research Organization, IVD firms, Compressed Medical Gas, Blood and Medical Device Industries, 14 years in the pharmaceutical manufacturing environment, 6 years of hospital laboratory experience, 11 years of management experience, and 2 years of experience teaching in the Biological Sciences Department at a University and a local college.
Discounted member price: 250.00
Your price: 480.00
You could save 47.9%
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

Approximate Course Duration: 60 minutes (this is a self-paced course)

*NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

Member Price: $ 250.00 / € 228.00
Non Member Price: $ 480.00 / € 437.00