Showing 1-10 of 19 results

cGLP for Nonclinical Laboratory Studies

January 27, 2021
0
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
0
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 …

Regulatory Approval for Medical Devices

August 9, 2020
0
Regulatory Approval for Medical DevicesCertificate Short CourseCourse DescriptionLearning OutcomesSchedule The Food and Drug Administration is responsible for ensuring that medical devices are safe and effective for their intended uses before …

cGMP for (Bio)Pharmaceuticals

August 9, 2020
0
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
0
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
0
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 …

Guide to FDA Warning Letters

July 29, 2020
0
Guide to FDA Warning LettersCertificate Short CourseCourse DescriptionLearning OutcomesSchedule The outcome of regulatory inspections is critical to an organization’s success. In the event the inspection results in FDA 483 observations …

Good Documentation Practices

July 29, 2020
0
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 …