Showing 1-10 of 19 results
Teaching Good Manufacturing Practices (cGMP) as a Workplace SkillIntegrating cGMP into Bioscience CurriculaCourse DescriptionLearning OutcomesSchedule Current Good Manufacturing Practices (cGMP) are federal regulations followed by drug manufacturing companies to ensure …
cGLP for Nonclinical Laboratory StudiesCertificate Short CourseCourse DescriptionLearning OutcomesSchedule This lecture-based, 2.5-hour live webinar covers the FDA's current Good Laboratory Practice (cGLPs) regulations and how they affect the conduct of …
Writing Controlled DocumentsCertificate Short CourseCourse DescriptionLearning OutcomesSchedule Current Good Manufacturing Practices (cGMPs) in a regulated industry require the use of controlled documents. Participants in this course will learn strategies for …
Regulatory Approval for Medical DevicesCertificate Short CourseCourse DescriptionLearning OutcomesSchedule The Food and Drug Administration is responsible for ensuring that medical devices are safe and effective for their intended uses before …
cGMP for (Bio)PharmaceuticalsCertificate Short CourseCourse DescriptionLearning OutcomesSchedule This lecture-based, 2.5-hour live webinar course covers 21 CFR Parts 210, 211, and 600. Topics include the current Good Manufacturing Practices (cGMPs), regulatory …
Core Concepts of Biomanufacturing and Quality SystemsCertificate Short CourseCourse DescriptionLearning OutcomesSchedule This course provides future or current employees a comprehensive and applied understanding of how regulatory compliance is built into all …
Quality AuditsCertificate Short CourseCourse DescriptionLearning OutcomesSchedule Good Manufacturing Practices are regulations to ensure proper design, monitoring, and control of manufacturing processes and facilities. These processes involve strict adherence and compliance …
Medical Device Design ControlsCertificate Short CourseCourse DescriptionLearning OutcomesSchedule There are more than 6500 medical device companies in the United States. These large and small companies produce a wide range of …
Guide to FDA Warning LettersCertificate Short CourseCourse DescriptionLearning OutcomesSchedule The outcome of regulatory inspections is critical to an organization’s success. In the event the inspection results in FDA 483 observations …
Good Documentation PracticesCertificate Short CourseCourse DescriptionLearning OutcomesSchedule Good Documentation Practices are critical within organizations implementing a controlled document system. With an emphasis on maintaining a system of control, participants will …
