Facilities Management Training Course

The purpose of this facilities management training course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.

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Why Should You Attend:

This course focuses on providing an understanding of the U.S. Food and Drug Administration's current Good Manufacturing Practices (cGMP) regulations on Building and Facilities for drug manufacturing, processing, packing, or holding. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. A link to these regulations on the FDA's website is available in the Resources tab of this course.

Areas Covered in the Webinar:
  • Design and Construction Features (Sect. 211.42)
    • Space, Size and Location (a)(b)
    • Preventing Contamination and Mixups (c) (1 - 10)(i-vi)
    • Special Considerations for Penicillin (d)
  • Lighting (Sect. 211.44)
    • Lighting (Sect. 211.44)
  • Ventilation, Air Filtration, Air Heating and Cooling (Sect. 211.46)
    • General Requirements (a)(b)
    • Air Filtration Systems (c)
    • Special Considerations for Penicillin (d)
  • Plumbing (Sect. 211.48)
    • Potable Water (a)
    • Drains (b)
  • Sewage and Refuse (Sect. 211.50)
    • Sewage and Refuse (Sect. 211.50)
  • Washing and Toilet Facilities (Sect. 211.52)
    • Washing and Toilet Facilities (Sect. 211.52)
  • Sanitation (Sect. 211.56)
    • General Requirements (a)
    • Sanitation Procedures (b)(c)(d)
  • Maintenance (Sect. 211.58)
    • Maintenance (Sect. 211.58)
Who Will Benefit:
  • Professionals Who are Responsible for the Management, Operation and Maintenance of Facilities (Buildings, Production Facilities, Utilities, Power and Water Distributions Networks Landscaping, Etc.)
  • Professionals Aiming to Update Themselves on the Basic Elements, Best Practices and Implementation Aspects of Facilities Management
Instructor Profile:
Kelly Thomas Kelly Thomas

Vice President, Americas Quality Operations at Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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