cGMP for (Bio)PharmaceuticalsCertificate Short CourseCourse Description This lecture-based, 3-hour live webinar course covers 21 CFR Parts 210, 211, and 600. Topics include the current Good Manufacturing Practices (cGMPs), regulatory compliance, …
Teaching Good Manufacturing Practices (cGMP) as a Workplace SkillIntegrating cGMP into Bioscience CurriculaCourse Description Current Good Manufacturing Practices (cGMP) are federal regulations followed by drug manufacturing companies to ensure their …
cGLP for Nonclinical Laboratory StudiesCertificate Short CourseCourse Description This lecture-based, 3-hour live webinar covers the FDA's current Good Laboratory Practice (cGLPs) regulations and how they affect the conduct of nonclinical …
cGMP for (Bio)PharmaceuticalsCertificate Short CourseCourse Description This lecture-based, 3-hour live webinar course covers 21 CFR Parts 210, 211, and 600. Topics include the current Good Manufacturing Practices (cGMPs), regulatory compliance, …
Equipment QualificationCertificate Short CourseCourse Description Product quality is dependent on the operational efficacy of the manufacturing systems, their components, and their integrated functionality. Equipment qualification is a critical step to …
Core Concepts of Biomanufacturing and Quality Systems (CCB)Certificate Short CourseCourse Description 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 Course Course DescriptionLearning OutcomesSchedule There are more than 6500 medical device companies in the United States. These large and small companies produce a wide range …
Guide to FDA Warning LettersCertificate Short Course Course DescriptionLearning OutcomesSchedule The outcome of regulatory inspections is critical to an organization’s success. In the event the inspection results in FDA 483 …
Good Documentation PracticesCertificate Short Course Course DescriptionLearning OutcomesSchedule Good Documentation Practices are critical within organizations implementing a controlled document system. With an emphasis on maintaining a system of control, participants …
FDA Labeling RegulationsCertificate Short Course Course DescriptionLearning OutcomesSchedule Medical devices sold within the United States must comply with the labeling requirements contained in 21 CFR Part 801. This course introduces …