Computer Software Assurance (CSA)
This training lecture will help you to understand the draft guideline requirements for computer software assurance and further will provide you clarity about General Principles of Software Validation guidelines by the FDA and 21 CFR parts 820.70 and 820.72 for medical devices. During this session, the viewers will learn about how to assure computer software practically. The training contents are detailed below; Brief introduction of the topic and scope Know your Trainer Regulatory Expectations Draft Guideline Recommendation Expectations from 21 CFR part 820 General Principles of Software Validation – FDA Computer Software Assurance Risk Framework Identifying the Intended Use Determining the Risk-Based Approach Determining the Appropriate Assurance Activities Establishing the Appropriate Record Q&A session.
What you’ll learn
- Computer Software assurance.
- How CSA and CSV are different whether CSA will replace CSV?.
- Inspection Readiness for computerised system.
- Business Continuity Plan (BCP) and Disaster Recovery Plan(DRP).
Course Content
- Introduction –> 5 lectures • 2hr 31min.
Requirements
This training lecture will help you to understand the draft guideline requirements for computer software assurance and further will provide you clarity about General Principles of Software Validation guidelines by the FDA and 21 CFR parts 820.70 and 820.72 for medical devices. During this session, the viewers will learn about how to assure computer software practically. The training contents are detailed below; Brief introduction of the topic and scope Know your Trainer Regulatory Expectations Draft Guideline Recommendation Expectations from 21 CFR part 820 General Principles of Software Validation – FDA Computer Software Assurance Risk Framework Identifying the Intended Use Determining the Risk-Based Approach Determining the Appropriate Assurance Activities Establishing the Appropriate Record Q&A session.
The other lecture will help you to understand the keys of Inspection Readiness For Computerised Systems. How to ensure cGMP compliance with respect to computerized systems. This video will help to prepare for audits and successful audit results by different regulatory agencies for example FDA,PIC/S,WHO,EUGMP,TGA etc. This short video lecture will help you to understand overall expectations about computerized systems from different regulatory agencies.
Another short video lecture will help viewers to understand Quality Risk Management principles, how it is simple and easy to implement, and achieve the compliance level. We have explained this with simple examples
There is more training lecture will help you to understand the common errors related to cGXP computerized system. Irrespective of performing validation and compliance to part 11. The purpose of this video to make procedures and systems in organizations in GMP GMP-compliant manner.
There is one video lecture that will be helpful in understanding the very important step of computerized system validation. This step is,”Business continuity plan” (BCP). This video will take you through the meaning of this terminology, why a disaster recovery plan is not the same as a business continuity plan, and what are steps involved in developing robust BCP plans. Also, this video will make you aware of some FDA citations about this topic.