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Other Links:
GMP Top 20 Observations Countdown
GLP Guides ISO 17025 M&E Part 11 Quality QSR Qualstar Sampling Suppliers Training Validation
| On-Site GMP and Compliance
Training Classes
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| Topic Click the title for a detailed course description |
Short Description |
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GMP Essentials for Management |
Learn about the GMP responsibilities of management as the number of observations in this area continues to increase. |
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GMP Essentials - Medical Devices |
Review the GMP regulations in a fun and effective learning environment. |
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GMP Olympics - Medical Devices |
Challenge your team's knowledge of GMPs in this playfully competitive classroom semi-simulation. |
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Qualstar Pharmaceutical: A CGMP Simulation |
In a simulation setting students learn the importance of procedures and documentation. |
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Root Cause Analysis for Better Investigations |
By working through actual plant site deviations, students learn how to conduct a thorough deviation investigation. Projects can focus on deviations from manufacturing, packaging, quality systems, laboratory and other areas. |
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Writing Better Investigation Reports |
The critical components of deviation investigation reports are reviewed and then students practice writing actual reports stemming from plant deviation investigations. This class should be taught in a computer laboratory. |
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Writing More Effective Procedures |
The most common components of standard operating procedures are reviewed and then students practice writing actual procedures. This class should be taught in a computer laboratory. |
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Auditing for Compliance |
This class outlines an auditing process and students then plan for an audit. In some cases students may be able to then conduct an in-house audit for practice. |
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Failure Mode Effects Analysis |
The process of conducting an FMEA are discussed and then students plan and implement an FMEA for a plant issue. |
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Good Laboratory Practices for Manufacturing Supporting Labs |
Review the GMP regulations as they relate to the manufacturing supporting laboratory in a fun and effective learning environment. |
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FDA Inspection Training |
Walk through an FDA inspection and practice responding to inspectors questions. Make sure your team is prepared for the FDA or other regulatory bodies. |
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Critical Thinking In Regulated Environments |
In this class students are thought 35 critical thinking elements to assure that deviation investigations, investigation reports, 483-responses and other important documents address are the important issues. |
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Overcoming Human Errors |
Only 7 percent of errors in the plant are really human errors, yet how do we over them. Learn how in this class. |
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GMP Essentials - Medical Devices |
Review the QSR regulations for medical devices in a fun and effective learning environment. |
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GMP Trainer Certification |
So now you are a GMP/QSR Trainer. Learn how to present, design activities, conduct activities and conduct the activity debrief. Enter the classroom for your next class with the confidence that your class will be fun and effective. |
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ISO 17025 |
Learn about the expectations of testing laboratories and calibration labs through this interactive session. |
| Call us if you have a customized training need! |
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Continuous
Improvement |
Click the topic for outlines
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Inquiry |
Telephone |
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Information via Email |
(415) 487-3500 |
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Corporate and Consulting Services |
(415) 487-3500 |
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Sales: Product and Services |
(804) 938-4102 |
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Designated Representative - California Board of Pharmacy |
(415) 487-3500 |
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Exemptee Certification - California Department of Health |
(415) 487-3500 |
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Fax orders to |
(415) 487-1926 |
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Webmaster |
(415) 487-3500 |
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Product and Service Support |
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| On-line tech support for CBT classes | Click Here | |
| On-line tech support for on-line purchases | Click Here | |
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Live computer based training tech support |
(415) 487-3500 |
Allan |
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Live GMP Content questions |
(415) 487-3500 |
Allan or Jackie |
| Postal address | 584 Castro Street #729 | San Francisco, CA 94114 |
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