January 27, 2009 Michaels at Shoreline, Mountain View, CA
Good Manufacturing Practices
This class is designed to teach GMPs for the 21st Century based on recent FDA and International GMP requirements. Basic concepts of GMP including Personnel, Facilities, Equipment, Materials & Process Controls as well as Documentation are demonstrated using up to date examples relevant to the group. This class is a fun introduction or refresher on manufacturing and quality practices.
Topics
covered include:
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History and purpose of GMPs |
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Areas covered by GMP with examples |
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Raw materials, production and process controls |
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- Materials controls and QC |
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- Design Control and Validation |
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- Manufacturing Process Controls |
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- Quality and Documentation |
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- Cleanliness requirements – appropriate to attendees industry |
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Validation basics |
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In-process and finished product labeling |
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Documentation basics |
Intended Audience: This class is intended for personnel new to GMPs. It is also an excellent refresher for managers and quality personnel who may have to convey GMP information to employees at their own companies. Copies of regulations and guidance will be provided to all attendees.
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Class offered: January 27, 2009 Michaels at Shoreline, Mountain View, CA |
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