Showing 1-10 of 18 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 …
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 …
Equipment QualificationCertificate Short CourseCourse DescriptionLearning OutcomesSchedule Product quality is dependent on the operational efficacy of the manufacturing systems, their components, and their integrated functionality. Equipment qualification is a critical step …
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 …
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 …
FDA Labeling RegulationsCertificate Short CourseCourse DescriptionLearning OutcomesSchedule Medical devices sold within the United States must comply with the labeling requirements contained in 21 CFR Part 801. This course introduces the …
Environmental MonitoringCertificate Short CourseCourse DescriptionLearning OutcomesSchedule Environmental monitoring of cleanrooms and adjacent areas is an extremely critical component of a company’s contamination control strategy, and is required for regulatory compliance. …
