By addressing fundamental regulatory compliance principles relative to the FDA's current Good Laboratory Practice regulations, this course will show how GLP's affect the conduct of non-clinical laboratory research, QA audit programs and FDA inspections. You will gain an in-depth understanding of specific critical GLP requirements such as the role of the QAU, study director, test and control articles. Preparation for FDA GLP inspections and current inspection trends, basic elements of GLP documentation, and considerations for lab facilities, equipment, and animals are covered.
Course Number: BIOL-40085
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management, Regulatory Affairs Essentials
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1/9/2023 - 3/13/2023
$645
Online
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CLASS TYPE:
Online Asynchronous.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Ajit-Simh, K A, President, Shiba Biotechnology
K.A. Ajit-Simh established Shiba Biotechnology Inc., in 1999 to provide regulatory compliance, quality strategy and support to the biotechnology, pharmaceutical and medical device industry. Ajit has worked with several multi-national pharmaceutical companies and products over his 30+ years in this industry. Ajit has successfully hosted U.S. FDA and EMA inspections and conducted several mock pre-approval inspections (PAI) which led to successful outcomes. He is a member of PDA and is an adjunct professor and instructor at SDSU in regulatory affairs.
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TEXTBOOKS:
No information available at this time.
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POLICIES:
No refunds after: 1/16/2023.
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1/9/2023 - 3/13/2023
extensioncanvas.ucsd.edu
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
-
4/3/2023 - 6/5/2023
$645
Online
-
-
-
CLASS TYPE:
Online Asynchronous.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Ajit-Simh, K A, President, Shiba Biotechnology
K.A. Ajit-Simh established Shiba Biotechnology Inc., in 1999 to provide regulatory compliance, quality strategy and support to the biotechnology, pharmaceutical and medical device industry. Ajit has worked with several multi-national pharmaceutical companies and products over his 30+ years in this industry. Ajit has successfully hosted U.S. FDA and EMA inspections and conducted several mock pre-approval inspections (PAI) which led to successful outcomes. He is a member of PDA and is an adjunct professor and instructor at SDSU in regulatory affairs.
-
TEXTBOOKS:
No information available at this time.
-
POLICIES:
No refunds after: 4/10/2023.
-
4/3/2023 - 6/5/2023
extensioncanvas.ucsd.edu
You will have access to your course materials on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
There are no sections of this course currently scheduled. Please contact the Science & Technology department at 858-534-3229 or unex-sciencetech@ucsd.edu for information about when this course will be offered again.