cGMP for (Bio)PharmaceuticalsCertificate Short Course Course details coming soon! YOU MAY ALSO LIKELEARN MORE Core Concepts of Biomanufacturing and Quality Systems Harry W. Rambo & Houda D. Pruitt Document Management, …

Equipment QualificationCertificate Short CourseCourse DescriptionLearning OutcomesCertificate PathwaySchedule Product quality is dependent on the operational efficacy of the manufacturing system components and their functions. Equipment qualification is the process by which …

Core Concepts of Biomanufacturing and Quality Systems (CCB)Certificate Short CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule This course provides future or current employees a comprehensive and applied understanding of how regulatory compliance is built …

Medical Device Design ControlsCertificate Short CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule 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 CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule 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 CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule 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 CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule Medical devices sold within the United States must comply with the labeling requirements contained in 21 CFR Part 801. This course introduces …

Environmental MonitoringCertificate Short CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule Environmental monitoring of cleanrooms and adjacent areas is an extremely critical component of a company’s contamination control strategy, and is required for regulatory …

Cleanrooms & GowningCertificate Short CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule Cleanrooms are controlled environments in which airborne and surface bound particles are limited based on the classification of the space. Maintaining particulate …

Laboratory Safety: Chemical Hygiene PlansCertificate Short CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule The OSHA health standards apply to all companies and their employees tasked with using chemicals in the workplace. With emphasis …