One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations, Root Cause analysis, CAPA & risk assessment. The FDA uses the investigation reports and investigation trends to identify potential quality problems and action plan taken in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required.
Having a procedure on investigations, Root Cause analysis, CAPA & risk assessment is not enough. It is the strategy, content, extent of efforts made and final conclusions that truly count.
This seminar will help attendees understand the fundamental steps, practical approach towards investigations, Root Cause analysis, CAPA and proactive approach as well as reactive approach of risk assessment.
Key focus will be put on practical examples, implementation & compliance practices with respect to current guideline requirements, FDA citations and learning from observations.
CEO of NADH+ GXP Compliance Services
Member of American Society for Quality &
Indian Pharmaceutical Association.
HITENDRA KUMAR SHAH
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 vendors/suppliers and trained more than 3000 candidates.
Sun Pharma, Alembic, Blue Cross Laboratories, Zydus Cadila, Titan Laboratories, USV, Astra Zeneca, Sanofi & Mylan
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