Showing 1-10 of 19 results

Writing Controlled Documents

August 9, 2020
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Writing Controlled DocumentsCertificate Short CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule Current Good Manufacturing Practices (cGMPs) in a regulated industry require the use of controlled documents. Participants in this course will learn strategies …

Regulatory Approval for Medical Devices

August 9, 2020
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Regulatory Approval for Medical DevicesCertificate Short CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule The Food and Drug Administration is responsible for ensuring that medical devices are safe and effective for their intended uses …

cGMP for (Bio)Pharmaceuticals

August 9, 2020
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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, …

Core Concepts of Biomanufacturing and Quality Systems

August 9, 2020
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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 …

Quality Audits

August 9, 2020
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Quality AuditsCertificate Short CourseCourse DescriptionLearning OutcomesCertificate Pathway(s)Schedule Good Manufacturing Practices are regulations to ensure proper design, monitoring, and control of manufacturing processes and facilities. These processes involve strict adherence and …

Quality Management

July 29, 2020
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Quality Management Certificate Certification Requirements: Select five (5) from any of the Required Courses listed below Select three (3) from any of the Elective Courses listed below Required Courses Basics …

Medical Device Design Controls

July 29, 2020
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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 Letters

July 29, 2020
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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 Practices

July 29, 2020
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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 Regulations

July 29, 2020
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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 …