The most vital tool available for assuring product quality, integrity, and consistency is good documentation practices. This highly interactive course covers fundamental principles and techniques required to write cGMP procedures. Students can bring samples of their own documentation to be audited during the course. Students will learn techniques to write and improve cGMP documentation to ensure compliance with regulatory documentation.
Topics Include:
- Document Hierarchy, Document Pyramid
- SOPs
- Document Control
- Laboratory notebook Con
- Data Integrity and GXP Compliance
- Auditing
Practical Skills:
- Understand the fundamental laws and regulations applied to various stages of product development
- Authoring documents fundamental to GXP compliance, such as SOPs, Work Instructions, Data Collection Forms and Document Templates.
- Maintaining Laboratory Notebooks for R&D work and assessment of the same
- Auditing documents to ensure data integrity that is critical to an effective Quality System, including the importance of having supportive documents, such as raw data and Training Records
- Applying Technical Writing techniques important to scientific documents and understanding the difference between poorly documents and the consequences of the latter
- Understanding fundamentals of Change Control and Documentation Management.
- When to communicate electronically and when this might not be the best venue for communication
Course Number: BIOL-40201
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs Essentials
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4/1/2024 - 6/10/2024
$725
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.
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POLICIES:
No refunds after: 4/8/2023.
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4/1/2024 - 6/10/2024
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.