CSV & IT SYSTEMS VALIDATION

e-COMPLIANCE

CONFERENCE

SEPTEMBER 26 - 27, 2019

HOTEL ITC KAKATIYA, HYDERABAD, INDIA

DOWNLOAD BROCHURE

Computer System Validation & IT Systems Validation Conference – 2019 will provide you with suggestions on how the current regulatory developments have to be put into practice. Computer System Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for Computer System Validation, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include Computer System Validation.

This course will build on the Validation and 21 CFR 11 Compliance, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management.

The event is interactive and encourages the active participation of all attendees. Methodologies used in the lectures are workshops, keynotes and discussion sessions. We encourage delegates to use this opportunity to bring questions from your own practice up for discussions. The conference will have breakout sessions for delegates to choose their preferred track, consisting of workshops and keynotes divided for Technical (production & quality) & IT professionals.

Featured speakers

Our speakers come from all over the globe. You’ll hear from renowned industry leaders and visionary designers.

Dr. Teri Stokes

Founder & Senior CSV Consultant at GXP International, USA

30+ years as a global consultant, auditor, trainer, and practitioner in computerized system validation (CSV) practices. She has been an invited speaker at industry conferences in Europe, North America, and Asia.

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Computer System Validation

Carolyn Troiano

CSV & FDA Expert

30+ years of experience in CSV & large-scale IT system implementation projects. Collaborated with FDA and other industry representatives on 21 CFR Part 11 back in the mid-1980s,.

Computer System Validation

KalpeshKumar Vaghela

CEO of Infra Control Systems

30+ years’ experience as Software Validation Specialist, GAMP5 and 21 CFR Part 11 Compliance

14 Amazing Keynotes

Learn and Network with the best in the Industry. The ultimate CSV & IT Validation experience!

Ranjit Barshikar

QbD / cGMP Consultant

Mayur Parmar

ex-Drugs Inspector, FDA Gujarat

Suryamohan Surampudi

Head – Electronic Data Systems Compliance, Plant IT Systems & Automation

Dr Reddy’s Laboratories

Computer System Validation

Anand Rao. C

Associate Vice President,
Head QA and CSV

Navitas Life Sciences

Computer System Validation

Arani Chatterjee

Senior Vice President,
Clinical Research

Aurobindo Pharma

Rajeshwari Bijur

Head of QC & CSV

Xybion Corporation

Computer System Validation

Sudhir Kumar Gupta

Lead Quality , IT Department – Biopharma Division

Intas Pharmaceutical

Rana Golzar

CSV Expert,Iran

Pharma Green System Co.

Ms. Vanita Khatter

Head Advisory Services

UL

Vikas Monga

DGM IT Operations – Pharma-life Science

Mylan

Damodharan Muniyandi

Global Quality and Regulatory Affairs

SAI LIFE SCIENCE

Sharmila Valleru

Head – GxP, CSV and IT Compliance Services

PwC, India

Francesco Abbate

Project Manager

Pharma Quality Europe

Key Areas Covered

  • CSV Trends & Regulatory Insight
  • 21 CFR Part 11 Gap Assessment
  • Data Integrity Masterclass
  • Paperless Validation
  • Adopting ‘Paperless Labs’
  • Documents, SOPs, Change Control and Audit Trails
  • FDA Audits and Inspections
  • SDLC Methodology
  • Computer Systems Controls
  • Vendor Selection Process
  • Cloud Computing and Cloud Validation
  • Project Management Best Practices for CSV
  • GAMP® Methodology
  • Developing an IT Infrastructure
  • Risk Management in Validation
  • Cyber Security

The FDA has issued many Warning Letters emphasizing Computer System Validation & Data Integrity non-compliance. These serious findings include:

  • Having interrupted
  • Missing, Deleted and Lost data
  • Inadequate records for risk analysis
  • Failure to exercise appropriate controls
  • Failure to validate computer software
  • Failure to establish validation procedures
  • Manipulation and deletion of audit trails.. and many more.

Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are on target of inspectors. The time has never been more critical to evaluate and ensure your organization has top-notch compliant procedures. To ensure that companies successfully pass Regulatory inspections and to also make sure that companies smoothly adopt latest tools & technologies available for validation, Compliance Trainings is pleased to announce the “CSV & IT Systems Validation Conference – 2019”.

  • Connect with IT, CSV and validation experts within the life sciences industry
  • This CSV & IT conference is a proven venue for knowledge exchange and valuable hands-on learning
  • The conference features two main content streams to meet the educational requirements, mainly – Quality and IT
  • Stay Up-to-Speed with Regulatory Thinking
  • Shape and magnify your understanding of the regulatory requirements and expectations for the compliance of computerized systems used in pharmaceutical manufacturing
  • Learn to apply quality risk management and risk assessment concepts
  • Excellent networking opportunities to build relationships
  • Branding opportunities as well as taking advantage to meet potential clients face-to-face.

Industries
  • Pharmaceuticals
  • Medical Devices
  • Manufactures of APIs
  • Finished Products
  • Quality Control Laboratories
  • Contract Laboratories
  • Clinical Research Organizations
  • Biotechnology
  • Pharma Chemicals
  • Radiological Health
  • Regulated Food
  • Cosmetics
  • Pharma Software Developers
  • Automation & IT Companies

Departments
  • QA & QC
  • Regulatory Affairs
  • Research and Development
  • Training Departments
  • IT Departments
  • Documentation
  • Engineering
  • Manufacturing
  • Validation
  • Production
  • Laboratory Departments
  • Operations
  • Software Development
  • Facilities

Professionals
  • Directors, VP’s, CxO’s
  • General Managers
  • Senior Managers & Managers
  • Supervisors & Team Leaders
  • Validation Specialists
  • Documentation Specialists
  • Research Scientist
  • Project Managers
  • Analytical Chemists
  • Training Specialists
  • Auditors
  • Clinical Data Specialists
  • Technicians
  • Vendors & Suppliers

Testimonial

WHAT OUR PAST DELEGATES HAD TO SAY
Very well organized. Seminar was interactive and informative. Such an event must be conducted more often

HOD

Quality

By far, this has been on of the best seminar we have attended. Highly recommended.

General Manager

IT/QA

This is the third time our team has attended a Compliance Trainings seminar, and they never fail to provide better experience each time

Director

Quality

Perfect workshop to understand how to avoid warning letters and 483's. Highly recommended seminar. Please let us know when the next session will be held.

Sr. Director

Quality

Perfect workshop to understand how to avoid warning letters and 483s. Highly recommended seminar. Please let us know when the next session will be held. I would like more from our team to attend.

Sr. Director

Quality

Such a training is always required for directions to implementing guidelines. Brilliant session. Great interactive session with some of top-notch experts from the industry.

Asst. Vice President

Quality Assurance

The seminar was extremely helpful and informative along with current scenario examples. Our team had a great learning experience.

General Manager

Quality

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