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CSV and CSA training that changes how your team validates on Monday

Your team has read the FDA's CSA guidance and GAMP 5 second edition. The templates still get filled the old way. This one-day programme closes that gap, built around your own systems and instruments rather than a generic deck.

60 participants at Sun Pharma rated this day 4.8 out of 5 for how useful it was to their own work, in September 2026. See who I’ve trained

In their words

What the Sun Pharma team said after the day

Each participant was asked which idea from the day they would put to work first. These are their answers, quoted with their permission.

“Applying risk-based critical thinking to determine the appropriate assurance activity for each requirement, rather than using the same level of scripted testing for every function. I will also focus on documenting the rationale behind the risk rating and testing approach.”
Gajendra DhepteManager, Sun Pharma
“DRIVE & CSA strategy with CFT team before execution, wherever required.”
Kinjalkumar PandyaSr. Manager, Sun Pharma
“Apply the CSA in my next Application validation.”
Jignesh GuptaCSV IT Executive, Sun Pharma

What is CSA training?

CSA training teaches quality, validation and IT teams to apply Computer Software Assurance: the FDA's risk-based approach to computer systems, finalised in September 2025 and updated in February 2026. A good programme moves the habit, not just the knowledge, so risk decisions land at the function level and testing effort follows the actual risk. That habit change is what returns 25 to 50% less documentation with equal or better inspection readiness.

How the day runs

The programme is a working session, per batch of up to 30 participants, in person at your site. We work through the four-step CSA risk decision on your own system inventory: judge impact on quality and safety, identify the implementation method, rate the risk, right-size the testing. Participants leave having re-tiered real systems from their estate, with the DRIVE framework as the operating discipline and the transition rationale their Validation Master Plan will need.

Recent corporate programmes have been built around client instruments and QC/QA workflows on exactly this pattern. The same session runs for consultancy and capability-centre teams that deliver validation for their own clients.

Who teaches it

Sachin Bhandari has led the CSV to CSA shift at enterprise scale, sits on the Global GAMP Steering Committee, and has delivered more than 1,500 trainings. The examples come from live programmes, and the hard questions get real answers.

What your team takes away

  • The four-step CSA risk decision, practised on your own systems.
  • Right-sized template and testing patterns, scripted only where the risk earns it.
  • The reviewer habit shift: documented critical thinking instead of screenshots.
  • A transition rationale ready for the inspector who asks why.

What does a CSV to CSA training course cover?

The 8-hour day follows the questions a validation team actually faces: why validation got so heavy, what FDA CSA and GAMP 5 second edition changed, intended use, which functions carry high risk, scripted or unscripted testing, what you can rely on from the vendor, and what evidence is enough. Each delegate ends by naming one practice to retire.

Is this CSV training or CSA training?

Both. CSA is a risk-based way of doing computer system validation, so the course teaches CSV practice as FDA CSA and GAMP 5 second edition now expect it: risk decided per function, testing sized to that risk, and records an approver can sign. It suits people who already write, test or review validation deliverables.

Who is a good computer system validation trainer for a CSA transition?

Pick someone who has run the change on live systems and can answer an inspector's follow-up question. Sachin Bhandari has nearly 20 years in validation, sits on the Global GAMP Steering Committee, co-authored the ISPE GAMP India SIG whitepaper on Computer Software Assurance in July 2021, and has delivered 1,500+ trainings.

Who should attend CSV and CSA training?

QA, validation, CSV and IT people who own or approve validation work, plus the QC and lab system owners whose instruments sit in scope. Consultancy and capability-centre teams that validate for their own clients attend the same session. Leaders who need the decision frame first usually start with the shorter Leadership Orientation.

1,500+ trainings delivered  ·  Global GAMP Steering Committee  ·  GAMP 5 2nd edition · FDA CSA · ICH Q9

Questions teams ask

How long is the CSA training and how many people can attend?

The standard corporate format is one working day per batch of up to 30 participants, in person at your site. Two-day formats add supervised practice on the client's own validation deliverables. Larger groups run as multiple batches, often back to back on consecutive days.

Is the content specific to our systems?

Yes. The programme is rebuilt for each client around their own system inventory, instruments and SOPs. The risk-tiering exercises use your estate, so the outputs are usable the next morning rather than staying an example.

What does CSA training cost?

In India it is ₹3,00,000 for one day and ₹5,00,000 for two days, per batch of up to 30 participants, plus GST, with travel at actuals. International sessions are quoted per country, usually the same day you ask. Write to info@trustbridge-compliance.com or use the training request form with your dates and participant numbers.

Bring the CSA training in-house

Tell me your systems, dates and participant numbers, and you will have a quote the same day.

Request this training Or take the free CSA Maturity Check