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.CEO of NADH+ GXP Compliance Services Member of American Society for Quality & Indian Pharmaceutical Association
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.
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