CSV workshop from Compliance Trainings is the best workshop in India.

Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance

Multi-City 2-Day Workshops – 2020


These latest 2-day Seminars on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.

There is no doubt that data integrity is the current and future inspection focus of all regulatory health care agencies. More than 60% inspection reports such as 483’s and Warning Letters quote data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Our Presenters’ extensive years of experience in Data Integrity can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters.

This workshop provides the regulatory background and guides attendees through the complete record lifecycle from data evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA’s Part 11 and the Annex 11.

Our instructors will use examples and real life case studies to better illustrate the application of the techniques for any validation project. With effective implementation of learnings from this seminar, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation. Interactive exercises will be dispersed into and between the presentations.

DAY 1 :

Registration: 8.30 AM – 9 AM
Session Start Time: 9 AM


  • Understanding Validation
  • V Module
  • Roles and Responsibilities
  • Relation of CSV with Data Integrity
  • Validation Master Plan (VMP)

21 CFR Part 11

  • Important Observations
  • Annex 11
  • Legacy System, Open and Close System
  • Electronic Records & Hybrid Systems
  • Electronic Signatures, Digital & Biometric Signatures
  • Black Box and White Box
  • Learning from Recent Warning Letters related to Part 11
  • 21 CFR Part 11 compliance of a computer system

Computer System Validation

  • Understanding CSV & CSV as per GAMP 5: It’s Easy!! Really!!
  • CSV Components and Deliverables
  • User Requirement Specification (URS), Functional Specifications (FS) & Design Specification (DS)
  • TRM, SR, IRA and FRA
  • Execution of validation report
  • Computer systems vendor Assessment
  • GAMP 5 and GAMP 4 key requirements

Q&A and Networking: 5 PM – 5.30 PM

DAY 2 :

Session Start Time: 9 AM

CSV – Step-by-Step

  • Formation of Validation Team
  • Writing Effective URS
  • Deliverable SRS and GxP Assessment
  • Qualification (IQ, OQ, PQ, DQ)
  • Traceability Matrix
  • Effective Installation and Testing
  • Risk Based Approach per GAMP Category
  • Effective SOPs, Verification and Testing
  • Validation & Revalidation
  • Qualification vs Validation

Data Integrity

  • Understanding Data Integrity and Security
  • Most frequent data integrity issues & their impact
  • Knowing the occurrence of data integrity failures
  • ALCOA++
  • Good Data Management Practices
  • Data Backup, Restoration
  • Archival & Retrieval, Retention
  • Error handling and corrective action
  • Maintenance Qualification
  • Types of data fraud, organization culture and Integrity
  • Data integrity Inspections – How FDA & other Regulatory Authorities Inspect
  • Computerized Systems for Data Integrity
  • Introduction to Pharma 4.0 – How it will help to reduce data integrity issues


  • Discussion on FDA & EU citations
  • Learnings from observations
  • Avoiding Warning Letters and Reduce Cost

Q&A, Certification, Networking and Close: 5.30 PM

A must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Oral Solid Dosage Form, Contract Laboratories, Clinical research Organizations, Contract Research Organisations, Contract Manufacturing Organisations and Biopharma companies.



Quality Control | Quality Assurance | Research and Development | Laboratory |
Regulatory Compliance | IT/IS & Software Departments | Validation | Production & Manufacturing | Documentation | Training Departments



Managers & Supervisors | Senior Managers & Team Leaders | Directors, VP’s, CxO’s, General Managers, DGM’s, AGM’s | Analytical Chemists | Validation Specialists | Analysts | Consultants | Systems Administrators




Kalpesh Kumar Vaghela

Validation Expert

Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

G. Sundar

PharmQA Consultant

Mr. Sundar Ganesan is a quality practitioner with 24 + years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA and Japan guidelines. He assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems so that the company can succeed. Mr. Ganesan currently working as Director-Consultant at PharmQA Compliance services an independent consultant firm partners with US and Europe.

Brian G. Nadel

ex-FDA Official

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

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Terms & Conditions to Register for the Seminar

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

Payment Policy:

Payment is required to be made at least 10 business days prior to the date of the conference.

To make payment by Wire Transfer / Cheque / Credit or Debit Cards, kindly call our Customer Support to assist you with completing your registration. Payments to be made in full.

Customer Support: +91-80-4170-0521
Email: info@compliancetrainings.in

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 3 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material, locations or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

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CSV Multi-City Roadshow 2020