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GlobalCompliancePanel, Online Training Webinar
2011-03-17
Overview: 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: - Achieve satisfactory inspections more easily
- Higher assurance of new medical product approvals
- Minimize nonconformances
- 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 you should 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. Thus, each element in a manufacturer's control program has been implemented without regard for the effect of the other elements. As a result, potential complimentary synergies between control elements have typically been overlooked while gaping compliance issues may exist. A Contamination Control Master Plan (CCMP) is critical to help organize and streamline all of the required contamination control elements to ensure easy compliance. A CCMP defines to your organization, as well as to auditors, how you mitigate the risks of the specific contaminants for your products.
Areas Covered In the Seminar: - 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?
Who will benefit: - QA personnel
- Regulatory personnel
- Operations managers
- Microbiologists
- R&D Scientists
- Validation Personnel
- Training departments
- Consultants
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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2011-03-17
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Registration:
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Wednesday, March 17, 2011
10:00 AM PST | 01:00 PM EST | | | Live live online training only for one participant | | |
| | | | | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
| | | Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) | | |
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E-mail:
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webinars@globalcompliancepanel.com
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