CGMP for Dietary SupplementsCertificate Short CourseCourse Description The FDA regulates both finished dietary supplements and dietary ingredients to ensure they are appropriately labeled, and safe for the consumer. Described in …
Good Documentation PracticesCertificate Short CourseCourse Description Good Documentation Practices are critical within organizations implementing a controlled document system. With an emphasis on maintaining a system of control, participants will learn …
Corrective Action Preventive ActionCertificate Short CourseCourse Description This course will cover the CAPA system; the tools used to identify the root cause of deviations, methods used for root cause analysis, …
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 Studies (Live Online)Certificate Short CourseCourse Description This lecture-based, 3-hour live webinar covers FDA's current Good Laboratory Practice (cGLP) regulations and how they affect the conduct of …
Equipment Qualification (Asynchronous Online)Certificate 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 …
Quality Audits (Asynchronous Online)Certificate Short Course Course DescriptionLearning OutcomesSchedule Good Manufacturing Practices are regulations to ensure proper design, monitoring, and control of manufacturing processes and facilities. These processes involve strict …
Guide to FDA Warning Letters (Asynchronous Online)Certificate 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 Labeling Regulations (Asynchronous Online)Certificate 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 …
Environmental Monitoring (Asynchronous Online)Certificate Short Course Course DescriptionLearning OutcomesSchedule Environmental monitoring of cleanrooms and adjacent areas is an extremely critical component of a company’s contamination control strategy, and is required …