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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 |
| Learn about the GMP responsibilities of management as the number of observations in this area continues to increase. | |
| Review the GMP regulations in a fun and effective learning environment. | |
| Challenge your team's knowledge of GMPs in this playfully competitive classroom semi-simulation. | |
| In a simulation setting students learn the importance of procedures and documentation. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| The process of conducting an FMEA is discussed and then students plan and implement an FMEA for a plant issue. | |
| Review the GMP regulations as they relate to the manufacturing supporting laboratory in a fun and effective learning environment. | |
| Walk through an FDA inspection and practice responding to inspectors questions. Make sure your team is prepared for the FDA or other regulatory bodies. | |
| 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. | |
| Only 7 percent of errors in the plant are really human errors, yet how do we eliminate them. Learn how in this class. | |
| Review the QSR regulations for medical devices in a fun and effective learning environment. | |
| 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. | |
| Learn about the expectations of testing laboratories and calibration labs through this interactive session. | |
| Training Skills for Trainer | Learn how the professional trainers train others in job skills. Learn the basic principles of adult learning, presentation skills and coaching |
| Change Controls | Learn the regulatory requirements and common practices in change controls. Explore the reasons for change controls, required documentation and the different types of submissions. Call 415.487.3500 to discuss your learning needs. |
| Call us if you have a customized training need! |
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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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