Charles V. Gyecsek
Instructor Charles V. Gyecsek
Product Id 600440
Duration 75 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Facilities Cleaning in Cleanrooms and Controlled Environments


This live webinar concentrates on proper cleanroom cleaning, and discusses tools, equipment, agents, personnel training, extent, and frequencies.

It is a very practical training session intended to assist personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures. The key benefits of this course are:

  • In-dept understanding of cleanroom cleaning methods.
  • Achieve satisfactory inspections more easily.
  • Higher assurance of new medical product approvals.
  • Minimize nonconformances.
  • Reduce rates of batch rework and rejections.
  • Reduce cleaning-related environmental contamination issues.
  • Avoid product recalls.
  • Understand industry standards in cleanroom cleaning
Why should you attend: Cleanroom cleaning processes and methods have been scrutinized by FDA auditors due to their important role in cleanroom management.  Poor or substandard cleaning can result in manufacturing delays, nonconformances, recalls, and regulatory action. Therefore it is important to control cleanroom cleaning processes and ensure best practices are followed.

Areas Covered in the Session:
  • Learn about cleaning and what it accomplishes in the cleanroom.
  • Identify cleaning agents, tools, and equipment.
  • Discuss cleaning personnel training and qualification.
  • Identify the methods of cleanroom cleaning.
  • Identify and discuss extent and frequency of cleanroom cleaning.
Who Will Benefit:
  • Q auditors and personnel
  • Manufacturing Operators
  • Maintenance and Cleaning Personnel
  • Consultants
  • Operations managers
  • Microbiologists
  • Validation Personnel
  • Training departments

Speaker Profile
Charles Gyecsek is formerly of Hoffman LaRoche where he worked primarily in Validation, Microbiology, Quality, and Operations. During his career Charles set-up and managed one of the largest GMP cleanroom facilities in the US, encompassing more than 200 rooms in 3 separate facilities. Charles' extensive experience involves plant start-up, cleanroom design and renovation, quality system auditing, regulatory submission writing, microbiology, equipment and cleaning qualification, utility validation, water system design and validation, aseptic processing, risk management, and regulatory inspections and responses.

Charles is currently president of MIJ Enterprises whose Compliance Division provides personalized consulting and training services within FDA regulated industries pertaining to pharmaceuticals, diagnostics, devices, and biotech products. Their core mission is to help clients maximize the benefit of a quality system in order to provide innovative products and exceptional services to their customers.

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