Charles V. Gyecsek
Instructor Charles V. Gyecsek
Product Id 600441
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

Gowning Systems Used in Cleanrooms & Controlled Environments

Overview:

This live webinar concentrates on identifying cleanroom garment systems, how they should be used, management of their supply, and control of human variables.

Key benefits of this seminar include:

  • In-dept understanding of cleanroom garments and their use.
  • Reduce personnel-related environmental contamination issues.
  • Achieve satisfactory inspections more easily.
  • Minimize nonconformances.
  • Reduce rates of batch rework and rejections.
  • Avoid product recalls.
Why should you attend: Since humans are the major source of contamination in cleanrooms, special care must be taken to choose and provide proper garments to minimize the human impact on cleanroom quality.  Gowning systems are varied in material, composition, coverage, and control capabilities. The use and donning of the garments can also vary and needs to be controlled in order to establish a consistent manufacturing environment.

Areas Covered in the Session:
  • Identify what garment systems are available.
  • Identify and discuss good and bad cleanroom gowning.
  • Identify gowning techniques and sequence.
  • Discuss what role each garment part plays in contamination control and human safety.
  • Explore expectations of cleanroom garment suppliers.
  • Discuss cleanroom gowning tests and personnel qualification.
Who Will Benefit:
  • Q Auditors and Personnel
  • Manufacturing Operators
  • Maintenance and Cleaning Personnel
  • Operations managers
  • Microbiologists
  • Validation Personnel
  • Training departments
  • Consultants

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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