Showing 1-10 of 12 results

cGLP for Nonclinical Laboratory Studies

January 27, 2021
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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 …

Writing Controlled Documents

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

cGMP for (Bio)Pharmaceuticals

August 9, 2020
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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 …

Quality Audits

August 9, 2020
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Quality AuditsCertificate Short CourseCourse DescriptionLearning OutcomesSchedule Good Manufacturing Practices are regulations to ensure proper design, monitoring, and control of manufacturing processes and facilities. These processes involve strict adherence and compliance …

Medical Device Design Controls

July 29, 2020
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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 …

Good Documentation Practices

July 29, 2020
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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 Regulations

July 29, 2020
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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 …

cGMP for Medical Devices

July 29, 2020
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cGMP for Medical DevicesCertificate Short CourseCourse DescriptionLearning OutcomesSchedule This course provides an overview of medical device current Good Manufacturing Practices (cGMP), with a focus 21 CFR 820, and the systems …