Computer System Validation
&
Computer Software Assurance
Online Training
- 6th & 7th May 2021
Workshop Overview
This course has been updated to include the update on 21 CFR Part 11 and also electronic version of CFR part 11. Further we are ensuring to make you understand about the new FDA expectations for computer software assurance(CSA).
This fundamental course introduces participants to regulatory requirements for computerized
systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements.
Regulatory guidance provides a pragmatic and effective framework for achieving computerized
systems that are fit for intended use and meet current regulatory requirements.
The course will provide principles and an overview of the overall computer systems compliance.
What’s in it for you?
- This course will provide principles and an overview of the overall computer systems compliance
- This workshop de-mystifies computer system validation approach and sets out the principles which would equip the quality and technology professionals
- The workshop enables a pragmatic and consistent understanding of CSV and Data Integrity requirements
- It will benefit all who use cGXP computerized systems to perform their job functions
: Trainer :
HITENDRAKUMAR
CEO of NADH+ GXP Compliance Services Member of American Society for Quality & Indian Pharmaceutical Association
HITENDRAKUMAR
CEO of NADH+ GXP Compliance Services Member of American Society for Quality & Indian Pharmaceutical Association
Organizations worked
Sun Pharma, Alembic, Blue Cross Laboratories, Zydus Cadila, Titan Laboratories, USV, Astra Zeneca, Sanofi & Mylan
A Quality oriented professional with over two decades of experience in production, quality assurance, quality control, quality engineering, quality auditor, pharmaceutical regulations and regulatory audit compliance.
His area of expertise includes USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include, quality compliance, suppliers audit, build systems to encourage compliance with the principles of data integrity, computer system validation, training, risk assessment, facing the audits, preparation and review of audit compliance, qualification & validation, system development for CAPA effectiveness, stability studies & solving pre approval or post approval queries raised by regulatory agencies etc.
He has independently handled production, quality assurance and quality control department for more than 13 years. During tenure audited more than 500 endors/suppliers and trained more than 3000 candidates. Expertise in to preparation, review of FDA 483/Warning Letter response.
Who Will Benefit
This CSV and CSA Training Course will benefit all who use cGXP computerised systems to perform
their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
- Regulatory Affairs
- QA/ QC
- IT/IS
- Software Managers
- Project Managers
- Software vendors and suppliers
Media Partner
Pharma Utility, a magazine dedicated to news and services in the
Indian pharmaceutical industry.
IJDRA is Quarterly Open-access and peer-reviewed Journal circulated electronically and Print since 2013 .
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Delegates Fees
Standard Fees : Rs. 9,000/- + GST
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