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Human Error Investigations in Pharmaceuticals
- Importance of topic
- Regulatory requirements
- Human Error investigation
- Swiss Cheese model
- Mental model concept
- Role of GEMBA
- Most common 10 types of human errors
- Strategies for avoiding the Human Errors
- Variability and control of variability
Overview of the webinar
All the pharmaceutical organizations are working hard for GMP compliance so as to get good business. The business growth is achieved by following GMP norms so as to increase technical and financial strengths of pharmaceutical organizations.
As, pharmaceutical companies are dealing with lot of activities by multiple personnel there are big possibility of human errors. The errors may lead to product failure or audit failure which will have huge financial impact on organizations. Even many cases, product or production license also may be seized.
It is very important to know the possibilities of errors in pharmaceutical production so that the appropriate solutions or remediation can be planned.
Who should attend?
- Officer
- Executives
- Managers
- Global Quality Leaders
- Auditors
- Compliance Experts
- SME's
Why should you attend?
- On attending this workshop, a thought process shall be triggered which will induce the attendee to take steps to overcome the possible human errors.
- It will help in improving GMP compliance level of the organizations.
- During the course of workshop, participants will understand the easy, pragmatic and cost effective approaches for reducing the human errors
- These activities can safeguard the organizations from product failure or negative actions by the regulatory agencies.
Faculty - Mr.Hitendra Kumar Shah
A Quality-oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include Quality Compliance, Supplier Audit, building 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 preapproval or post-approval queries raised by regulatory agencies, etc.