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Overview

This training will discuss regulatory requirements for detecting, correcting and preventing human errors in manufacturing and laboratory environments along with developing a competent, effective corrective and preventive action system

Analysis of investigation reports reveal that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA’s that are developed from these, rewriting and retaining of SOPs emerges as main problem. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA’s are ineffective. Does it mean that the CAPA’s were wrong or is it pointing to another problem? Namely, that the investigation did not pinpoint the root cause of or most probable contributing factors to the problem. Most often “human error” is not really the problem but a symptom of a system or facility or operation that is not designed to be run by humans. Humans do contribute to problems but more often than not, because what we are asking them to do is not designed with humans in mind. So a true CAPA should be developed to solve the problems with the system, facility and operation rather than focus on remediation of people. This requires investigations to focus on getting to the real root cause and contributing factors.

This training will walk you through the elements of why we are quick to ascribe fault to people rather than our systems, facilities, and operations. We will hone in on how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPA’s that have a chance to remedy these problems, the first time. We will focus on how to assess the success of these CAPA’s. This will lead to a significant reduction of repeat observations which will lead to improved efficiency and right first time operations. This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes.

Trainer

Rajani Jha

IIT Kanpur Scholar, Synthetic Organic Chemistry, Trainer for QBD, GMP and Regulatory Affairs

Guest Speakers

Dr. Satya Moturi

Sr. VP and Head, Operations, Quality and Scientific Affairs.,
Biological E. Ltd

Dr. Srinivasu Topalli

Sr. General Manager,
Natco Pharma Limited

M. Gopi Reddy

Head-Corproate Quality,
Syngene International Ltd.

Sanjiv Donwalkar

Pharma consultant
Tantrasoft solutions Pvt Ltd

Learning Benefits :

  • Identify why human error is often designated the root cause of deviations and discrepancies.
  • Identify why your CAPA’s are less effective than you hoped.
  • Understand why human error is not the real cause of the deficiencies and deviations.
  • How to probe further to identify the causes or contributing factors that really cause the problems you are seeing.
  • How to develop a true CAPA for these problems.
  • Develop an efficient and effective CAPA system to remedy the ingrained problems.
  • Identification and prevention of human error during data entry.
  • Most common GMP issues caused by human error during laboratory and manufacturing processes.

Who Should Attend

Quality Assurance Personnel

Quality Control Personnel

Project Managers working in the CMC arena

Supply Chain and Logistics Managers

Regulatory Affairs Professionals

Process Development Scientists and Management

Manufacturing Management and Scientists

Silver Partner

Media Partner

Training Agenda

DAY 1

9:00 am

Registration & B/F

9:30 am

Welcome Address by Ashish Chauhan, Director, BlueTech Media

9:35 am

Module 1 : Overview of Human behaviour Impact in the Pharmaceutical arena 

  • Fault of people , systems, facilities or Quality Culture ?
  • How Human behavioural Choice can hinder Compliance
  • The human limitations & The human Advantages
  • Digitalization & Remote Working Various interlinked Covid-19 Aftermaths

11:30 am

Tea Break

11:45 am

Module 2: Regulatory/GMP Aspects as per Inspectional 483s & Warning Letters

  • The Global Regulations & Directives –
  • The sequence – Detection, Correction, Prevention & Control of human errors
  • Learning from GMP Inspections observations & concerns
  • Implementation via Robust Pharmaceutical Quality Systems

12:45 am

Speaker :- Sanjiv Donwalkar, Pharma consultant Tantrasoft solutions Pvt Ltd

Preventing Human Errors in Pharma GMP Manufacturing by Automation

  • Current Pharma Industry Scenario in Human Errors
  •  How Pharma Industry is handling Human Errors
  • Recommendations to Pharma Industry for prevention of Human Errors

1:00 pm

Lunch Break

1:45 pm

Guest Speaker : Dr. Satya Moturi, Sr. VP and Head, Operations, Quality and Scientific Affairs., Biological E. Ltd, 

Module: Human Errors – a Myth eclipsing root causes

  • The depth and complexity of Human errors
  • Paradigm shift in regulators approach
  • Traditional quality approaches Vs evolving theories for human errors
  • Key elements of human behaviour, Are we certain about root causes?
  • Is Pharma behind other evolved industries in addressing this more common and persistent problem?
  • Major gaps in industry’s understanding
  • Few typical examples for brain storming
  • Tips and suggestions for effective handling of human errors

2:15 pm

Module 3 : Criticalities of SOPs & Quality Oversight for Active Pharmaceutical Ingredients

  • Inadequate Written Procedures
  • Failure to Follow Written Procedures
  • No Risk evaluation Management Strategy

3: 15 pm

 Speed Networking & Tea Break

3:45 pm

Module 4 : Customized methodology/ Techniques for Investigating Human Errors

  • Analysis of human errors/outcomes wrt RCA, CAPA & Control Strategy [ies]

4:30 pm

Q&A Session with Speakers

Fees +GST

DAY 2

9:00 am

Registration & B/F

9:30 am

Welcome Address by Ashish Chauhan, Director, BlueTech Media

9:35 am

Recap of Day 1 & Setting the stage for Day 2 Session proceedings

9:50 am

Module 5: Risk Evaluation wrt different Categories of Human Error for APIs

  • Relevant Tools for choosing correct and appropriate CAPA
  • Adequate Deviation Management System wrt characterization of Deviations
  • Thorough Investigations & Scientifically justified Closure to arrive at RCA
  • SOPs & Training for Effective Control Strategies

11:00 AM

Tea Break

11:15 am

Module 6: Causes & Categorization of Human errors – Initiatives & Control strategies

  • Human Factor or System Factor ?
  • Disregarding Safety, Messing Around, Fatigue, Speed Working, Poor Training
  • Absence or Lack of Written Procedures or Failure to Follow Written Procedures
  • Failures in Laboratory Controls
  • Faulty Production Record Reviews
  • Improper Cleaning/Sanitizing/Maintenance

12:30 pm

Guest Speaker Session: Dr. Srinivasu Topalli, Sr. General Manager, Natco Pharma Limited

Module: Human Errors in Quality Control [QC] Laboratory

  • Understanding Human Errors
  • Regulatory Expectations
  • Current ways of Handling human errors
  • Types of Human errors
  • Investigation of Human errors
  • CAPAs
  • Case Studies
  • Q&A

1:00 pm

Lunch Break

1:45  pm 

Guest Speaker: Dr. Gopi Reddy, Head-Corproate Quality, Syngene International Ltd.

Module: Effects on Human behavior leading to errors due to Quality culture & Pandemic

  • What is Quality culture
  • Influence of culture on Human behavior or performance.
  • Pandemic & its impact on Human behaviors leading to errors.
  • Human errors due to poor systems/ procedures.
  • Case studies on Human errors- Oral solid dosage forms
  • Mitigation Actions to avoid Human errors

2:45 pm

Module 7: Effective Strategies for minimizing Human Error in the Workplace

  • Identification of the Error Reduction Zones in the manufacturing and quality control.
  • Designing Scope of Improvement for equipment, documentation and systems [PQS]
  • Redesigning of Procedures: Standard operating procedures and formats
  • Quality Oversight –Measures to Improve Supervision
  • Improved & Timely Communication across CFTS at Multiple Sites
  • Appropriate Work delegation & Adequate Training

3: 30 pm

Tea Break

3: 45 pm

Module 8 : Exemplary Case Studies for Human Error Handling

  • Real Life Examples from Cross functions of Pharmaceutical Activities
  • Human errors in deviations, discrepancies non-compliance & other quality incidents
  • Practical Challenges wrt implementation, solutions & the way forward

4:30 pm

Q&A Session with Speakers

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