Charles V. Gyecsek
Instructor Charles V. Gyecsek
Product Id 600487
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

Human Behavior in Cleanrooms and Controlled Environments


This live webinar concentrates on identifying good and bad cleanroom behavior. It provides training in cleanroom contaminants and how they are affected by humans.

The key benefits of this course are:

  • In-dept understanding of cleanroom contaminants.
  • Achieve satisfactory inspections more easily.
  • Higher assurance of new medical product approvals.
  • Minimize nonconformances.
  • Reduce rates of batch rework and rejections.
  • Reduce personnel-related environmental contamination issues.
  • Avoid product recalls.
  • Establish best personnel behavior and eliminate bad habits.
Why should you attend: Most human medical products, including drugs, devices, biologics, and diagnostics, are manufactured under controlled environmental conditions. Much effort is involved to design, build, validate, and operate these special environments to ensure that products are protected from contaminants.  The major source of contamination and variance in cleanroom operation is human-based.  It is therefore critical to ensure that human behavior is consistently controlled within the cleanrooms.

Areas Covered in the Session:
  • Identify the typical contaminants found in the cleanroom.
  • Identify the sources of cleanroom contaminants.
  • Discuss how personnel behavior affects the cleanroom.
  • Identify and discuss good and bad cleanroom behavior and habits.
Who Will Benefit:
  • QA auditors and personnel
  • Manufacturing Operators
  • Maintenance 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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