RAPS pre-approved webinar on "Disinfection and Clean room Cleaning in an FDA Regulated Environment"
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Disinfection and Clean room Cleaning in an FDA Regulated Environment" on March 5, 2013.
- San Jose, CA (1888PressRelease) March 05, 2013 - Description:
This webinar offers important insights into cleanroom cleaning.
Cleanroom cleaning is a vital aspect of a medical product. Since it is in cleanrooms that medical products are made; cleanroom cleaning is very important to ensure product approval. This webinar will focus on proper cleanroom cleaning and discuss tools, equipment, agents, personnel training, extent, and frequencies.
In addition to the obvious scientific need for this operation; cleanroom cleaning is important from the regulatory perspective as well. An idea of their importance can be gauged from the fact that FDA auditors actively scrutinize cleanroom cleaning processes and methods.
Another important reason for which best practices need to be followed in cleanrooms is that when a cleanroom facility fails to meet regulatory cleaning requirements; this can result in manufacturing delays, non-conformances, recalls, and regulatory action.
During the course of this very practical training session; personnel involved in the design, cleaning, monitoring, and assessment of cleanroom cleaning procedures will learn the intricacies of cleanroom cleaning.
This session covers the following areas:
- 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.
The key benefits of this course are:
- In-depth understanding of cleanroom cleaning methods
- Achieve satisfactory inspections more easily
- Higher assurance of new medical product approvals
- Minimize non-conformances
- Reduce rates of batch rework and rejections
- Reduce cleaning-related environmental contamination issues
- Avoid product recalls
- Understand industry standards in cleanroom cleaning
When:March 5, 2013,10:00 AM PDT | 01:00 PM EDT
By whom:
Charles Gyecsek is formerly of Hoffman LA Roche 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 three 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.
For whom:
The webinar will benefit
- Q auditors and personnel
- Manufacturing Operators
- Maintenance Cleaning Personnel
- Consultants
- Operations managers
- Microbiologists
- Validation Personnel
- Training departments
Duration: 60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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