We provide face-to-face class courses as well as customized onsite corporate training upon request on hot topics, regulatory guidance, manufacturing and quality compliance regulations, approval process, and relevant Best Practices (GMP, GDP, GCP, GLP, GVP, GPP, GTP, …) in drugs, medical devices, combination products, food & food ingredients, dietary supplements, and complimentary & alternative medicine. We cover theses subject globally (North America, European Union, Latin America, Asia Pacific, Africa, and Middle East). The length of the sessions varies and ranges anywhere from four hours (half day), one day, two days, and three days including a Q & A at the end of each session. These classes are held in different countries and in different languages and are mainly request-based. Simply search by category then browse to find the document you need. We will have a survey after the completion of all of our courses to collect your feedback for future improvements. You can print your certificate of attendance from the e-mail you receive upon filling out the survey after the session. New courses are added on a daily basis so please check often.
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This one-day On-in-class course covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), GDP as applies to laboratory notebook (paper and electronic) documentation, and GMP on non-clinical laboratory studies (21 CFR Part 58), document and record keeping best practices specifically as it applies to drugs and devices (21 CFR Parts 212, 211, 312, and 812), USP General Chapter <1029>, Rules Governing Medicinal Products in the European Union (Vol. 4: Documentation), and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.
