Introduction to Contamination Control Master Plans
Date & Time: Tuesday, October 11, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Charles V. Gyecsek
Price : $245.00
(for one participant)
Charles V. Gyecsek President, MIJ Enterprises, Inc.
This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an introduction to the creation, implementation, and maintenance of a Contamination Control Master Plan. Key benefits of this seminar include: l l l l
Achieve satisfactory inspections more easily. Higher assurance of new medical product approvals. Minimize nonconformance’s. Reduce rates of batch rework and rejections.
Avoid product recalls. Identify and control the key contamination concerns for your company. Take a holistic approach to contamination control.
Achieve synergy among control programs.
Why should you attend:
Manufacturers of human medical products have established myriad control programs to comply with FDA regulations regarding control of product contaminants. However, due to variable emphasis being placed on each of these control elements by FDA auditors, most manufacturers have developed their programs in a piecemeal fashion.
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. ...more
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Areas Covered in the Session: l l
What is a CCMP and how is it valuable to my company? What topics are covered in the CCMP and to what extent?
How is the CCMP controlled and updated? How is the CCMP implemented?
Who contributes to the CCMP?
Click here to register for this webinar Who Will Benefit: l l l l l l l l
QA personnel Regulatory personnel Operations managers Microbiologists R&D Scientists Validation Personnel Training departments Consultants
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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This webinar concentrates on the value of creating a master plan for contamination risks within a GMP manufacturing company. It provides an...