BENEFITS

1. This new intermediate level training course has been designed to familiarize trainees with key challenges encountered during CSV and how to overcome them using the newly released FDA’s guidance on “Computer Software Assurance (CSA)”. It also highlights the modifications required to existing CSV approach in order to accommodate the CSA approach.
2. This course benefits those who use computerized systems for health care, clinical trials, biopharmaceutical manufacturing, medical device industries and companies that use computerized systems that execute programs to create and store data required to be submitted to regulatory agencies on demand.  IT professionals engaged in the development of systems and software for the biopharmaceutical industry use would also benefit from this training.

WHO SHOULD ATTEND

1. Pharmaceutical industry / Medical device industry / Healthcare industry personnel
2. Developers of software for use in Life Sciences industry
3. Validation service providers, IT service providers
4. Manufacturing personnel and Manufacturing Automation system vendors and system integrators
5. Regulatory Affairs group, Quality Unit

COURSE SUMMARY

The Computerized Systems Validation (CSV) regulation of the USFDA, CFR 21.68 has required the biopharmaceutical industry to validate computerized systems used in the manufacture and distribution of computerized systems for their medicinal products. Their 2002 guidance on Software Validation has continued to be the source for how to perform CSV. The industry has interpreted this guidance in its own way and the current practice of providing “documented evidence” involves generating volumes of paperwork by way of screenshots. It is far from the regulatory agencies desire for the industry to understand the intended use of the system under validation, documented evidence for the results of their critical thinking on the use of the system etc.
Enter Computer Software Assurance (CSA) methodology which simplifies the current Computerized Systems Validation (CSV) by streamlining the validation process, CSA assists in achieving faster deployment of systems and Return on Investments (ROI). CSA and CSV are not all that different.

SPEAKER

Chinmoy Roy, BSEE, MSCS, USFDA expert
Chinmoy Roy is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, QRM and manufacturing process automation systems.  As a USFDA expert, he has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF etc.  His expertise stems from his 38 plus years of experience in implementing and obtaining “fit for use” certification for over 200 IT systems.  He has worked at and consulted with several leading companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. He has authored several QA Governance documents, facilitated numerous Quality Risk Assessments and provided input to ISA’s development of standards such as S88 and ISPE’s Records and Data Integrity guide. HHIs foundational experience is in Manufacturing automation to include PLCs, DCS and MES. His training workshops are unique in that he blends his field experience to provide practical situations to explain the intricacies of implementing regulations.  His trainees have found this approach as something that relates directly to their daily work situation.

CSV Regulatory imperative

• Validation regulations
• System Lifecycle and Validation lifecycle
• CSV documentation requirements
• VMP and VPP and what they should contain

Computer Software Assurance (CSA)

• Why CSA? What is wrong with CSV?
• What are the key focus areas of CSA
• Compare CSV approach to CSA approach
• Compare CSA deliverables with CSV deliverables

CSA contd

• Defining Intended Use
• Leveraging vendor’s validation
• Risk-based testing and documentation format
• Q&A session       

Develop critical thinking skills with examples

• The skills required to be a good critical thinker
• The different thinking styles
• A new 5-step process of thinking
• Q&A session

System Criticality using RAMP model

• What is the RAMP model
• Tools available for RAMP criticality scoring
• Q&A session

CSA for Cloud Applications

• What does CSV for Cloud Applications involve
• CSA for a Cloud application – A Case study
• Q&A