Computer System Validation


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DATE

Check this space for next year event updates

LOCATION

Mumbai

TIME

08:30 AM TO 05:30 PM

Our Workshop Leaders

Dr.Neelam Tripathi: Quality and Training Manager / CSV / SQA

  • Trainer, speaker, writer and CSV consultant – that is the amalgam which describes Dr Neelam Tripathi. She has explored Pharma and Healthcare world with several MNCs including TCS. Having more than 17 years of experience, she is an expert in CSV, 21 CFR Part 11, compliance and quality. She has trained teams for CSV, GDP, GCP, HIPAA and Healthcare.

    Worked primarily in the field of Software Quality Assurance (SQA), Computer System Validation (CSV). Expert in requirement gathering (URS and FRS), creating validation master plan (VMP) and other deliverables (RS, DS, RTM, Test Cases, VSR).Risk and compliance assessment. Test cases and defect management

    She ensured following for training management: Training need analysis , Creation of content, modules, and training plan , Ensuring 100% compliance on training schedules , Feedback analysis , Selection and co-ordination with faculty


Ramana Gadicherla: Strategic leader in IT / CSV / QA & Compliance for IT

  • Ramana Gadicherla is strategic leader with specializing in delivering large scale projects with Quality and Compliance. He is having extensive experience in FDA (GxP, 21 CFR Part 11), PIC/S, EUDRALEX and other regulations. He also having extensive experience in Consent Decree Remediation's. He is leader in implementing large scale programs like SAP, LIMS, Qualification of Data centers Experience in setting up and managing IT Regulatory CoE (Validation and Quality). He is specialist in managing quality, compliance, risk and security for very large engagements spread across the globe.

    His specialties include Program Delivery Management for Global delivery. Compliance and Quality Management. Life Sciences IT Compliance (FDA (21 CFR Part 11), IMDA, PICS, EUDRALEX). Building and Handling Validation/Quality CoE Internal / external and Vendor Audits. Gap Assessments for Consent Decree / 483 / Import Alert Remediation's. Stand Alone Systems Validation along with PLC Spreadsheet Validations. Large scale data center qualification Management of SOP, policies. Managed team size over 120 people across geographies. Trained over 500 members in Quality IT, testing methodologies Validation techniques, CSV, Quality standards, GxP.

Who should Attend

  • Novices
  • Advanced users
  • Senior management
  • Who use computer systems for laboratories, clinical trials, manufacturing, quality, validation
  • IT system vendors

Key Topics include

  • Pharmaceutical Quality Systems Elements (PQSE)
  • Data Integrity elements
  • Corrective and Preventive Action (CAPA)
  • Computer Systems Validation (CSV)
  • Implementation of Six Sigma concepts
  • Software Quality Assurance (SQA)

Workshop Include

  • Presentations
  • Panel discussion
  • Group discussion
  • One-to-one discussion
  • Chalk and talk
  • Case Studies

Some training highlights...

  • International developments in pharmaceutical manufacturing and their likely impact on GCC
  • The increased role of and techniques used by management to ensure compliance
  • What are the elements of a PQSE with examples of each (ICH Q10)
  • What is CAPA and what are compliance requirements for CAPA
  • What are the attributes of quality SOPs
  • Structure and example of a Validation plan
  • Data Integrity, CFR 21 Part 11 and Annex 11 and their differences
  • Validation considerations for Commercial off the shelf (COTS) software from software vendors
  • How to write good requirements documents and why are they always audited
  • Mock internal audit for PQSE, CSV and CAPA performed by trainees

Speakers of 2017

user

Sachin Bhandari
Head Computer System Validation

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Siddharth Gujarathi
Deputy General Manager

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Thirupal Neeraganti
Head-Process Excellence & Lean Six Sigma Quality

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Ananda Rao C
General Manager - QA, CSV and MR


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Ashwani Sharma
Manager

If you’re using computer systems for laboratories / clinical trials / manufacturing / quality / validation, you don’t want to miss this opportunity to meet with strategic leader in IT / CSV / QA.

Download The Prospectus To See How You Can Get Involved

Sponsorship Opportunities

Want to be in front of a large and engaged group of industry leaders who are serious about building relationships to build their businesses?

This event will provide sponsors with the unique opportunity to showcase their services and technologies to the most active stakeholders in the industry today! Do you have a solution that can help their challenges?

Request a Sponsorship Prospectus

MEET FOLKS THAT MATTER

Attendees have acquisition power and are actively looking for industry partners

GET NOTICED

From speaking, leading a round table, hosting receptions, there’s so many ways to highlight your company.

SHOWCASE YOUR SOLUTIONS

We hand pick the top vendors that can assist with our attendees challenges to showcase their solutions through and exhibit booth.

Contact Us

For Registraion

Rachna Tiwari

Conference Manager
rachna.tiwari@biotrains.com
+91 8433632006