INVESTIGATION,

ROOT CAUSE ANALYSIS,

RISK ASSESSMENT & CAPA

21st & 22nd January 2021

HURRY UP! LIMITED SEATS AVAILABLE...‚Äč

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ABOUT THE EVENT

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.

hitendra-shah

HITENDRA KUMAR SHAH

Course Director

CEO of NADH+ GXP Compliance Services

Member of American Society for Quality &
Indian Pharmaceutical Association.

21 & 22 January 2021

Save The Dates

About the Trainer :

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.

Organizations worked :

Sun Pharma, Alembic, Blue Cross Laboratories, Zydus Cadila, Titan Laboratories, USV, Astra Zeneca, Sanofi & Mylan

Register & Pay Now for Online Training, Fees 9000/-

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