Human Error Investigations in Pharmaceuticals
Hitendrakumar Shah Overview:
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.
Why you should 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.
Areas Covered in the Session:
- 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
- Q&A
Who Will Benefit:
- Quality Assurance
- Production
- Warehouse
- Quality Control
- Compliance
- Global QA
- Corporate QA And QC
Speaker Profile
Hitendrakumar Shah is 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, 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 preapproval or post approval queries raised by regulatory agencies etc.
Independently handled - Quality assurance and Quality Control department for more than 13 years.
Audits faced- USFDA (8 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (9 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.
Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments - HPLC, GC, FTIR, UV Visible spectrophotometer, AAS etc.