COURSE ID 2803

Cleaning Validation: Best Practices

AVAILABLE ON-DEMAND
Duration: 90 Minutes
Course Instructor

Joy McElroy

Price
$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Cleaning validation is one of the many GMP requirements critical to the production of a drug product or medical device. Unfortunately, product recalls due to inadequate cleaning still occur, indicating that implementation of an effective and compliant program is lacking in some companies. Because costly regulatory actions can have a significant negative impact on a company, a better understanding is needed.

This training course provides practical guidance on cleaning validation regulatory compliance in conjunction with risk-based, reasonable, and informed decision-making and activity planning. The course will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, cleaning SOPs, and other appropriate documentation. In addition, participants will understand the requirements for maintaining a validated cleaning process.

Upon completion of this course, you will be able to:

  • Outline the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
  • Explain the FDA perspectives on cleaning validation and areas of concern during regulatory inspections and become prepared to defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies
  • Write cleaning validation procedures, protocols, and final reports that meet FDA, WHO, PIC, and EU regulations
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This online training will benefit professionals in the Pharmaceutical, Biotechnology, Medical Devices, and other regulated industries.

It will be especially valuable to those working as:

  • Quality Engineers
  • Validation Engineers
  • Managers
  • Supervisors
  • Operators
  • Analysts
  • Auditors
  • Chemists
  • Quality Control
  • Manufacturing
  • Quality Assurance
  • Engineering
  • Research & Development

Managers and supervisors of this personnel will also benefit from this training by learning about the challenges faced by them.

Course Instructor

Joy McElroy

Consultant to the Pharmaceutical and Biotech Industries

Joy McElroy’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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