Human Errors in GMP Environment Workshop

– How to Investigate, Predict, Prevent, Correct & Recover Human Error

June 20 – 21, 2019

Hyderabad, TS, India

Human errors is no longer accepted as a cause of deviation in GMP environment by regulatory authorities. Investigations still remain a talked about topic of discussion in audits. There are several variables involved that may affect the human behavior including the environment, culture, management, training and procedures. You need to understand the psychology and behavior around an error to reduce the occurrence and correct the weakness of the system. The occurrence and recording of Human error as a leading root cause in pharmaceutical industry is very frequent. The impact of human errors can be severe causing complaints, recalls, regulatory action and batch rejects. The error can lead to reduced quality or even loss of life. ‘Lack of understanding’, ‘did not follow procedure’ or ‘missed a step’ are some common reasons assigned to human error.

In most cases the corrective action is re-training. Training doesn’t necessarily address the deviation because there is more to the root cause than just “human error”. Organizations fail to look at the ‘Why’ or ‘What’ and only the ‘Who’ is investigated and this certainly cannot stop the re-occurrence. Training, documentation, equipment designing are all taken into consideration to prevent occurrence but the errors continue. You re-design your quality systems and procedures, people still don’t comply and deviations continue. Regulators cite this as incomplete investigations and you end up with audit observations. The persistent problem requires basic understanding of human error analysis. Human errors can be reduced and prevented and so also the costs associated with them. This would prevent victimization and lead to fair and productive workplaces. To better understand which errors may lead to serious adverse outcomes, the risk needs to be assessed and appropriately addressed. This is not the end; there is a way around the ‘Human error’.


Why You Should Attend:

This workshop will benefit anyone working in a GMP environment including leadership, management, and other personnel in quality, manufacturing, engineering, and other regulated functions. This workshop will be very useful to those managing, leading, or working in a training function. The session will explain why it is important to understand human behavior and the psychology of error as well as to understand exactly where the instructions weaknesses are, so procedures can be human engineered, improved and/ or fixed. You will learn and understand the causes and measures, the psychology behind errors, human performance, conducting effective investigations, developing effective strategy through risk eliminations at the design stage, corrective and preventive actions, metrics for monitoring the effectiveness and sustenance.

The workshop will allow for a deeper insight into the underlying causes of human error in order to identify and avoid its sources. We will work through examples of potential causes and design for prevention at the organizational level. We will also look at FDA observations related to these situations and how a fresh approach can be taken to avoid the observations. The workshop will cover group exercises, brainstorming, and analysis of application of the model to your company to resolve “human error”.

Who Should Attend:

  • Quality Assurance Management and Staff
  • Quality Control Management and Staff
  • Manufacturing Management and Staff
  • Team Leaders
  • Executives and Senior Executives
  • Regulatory Affairs Management and Staff
  • Operations Management and Staff
  • Production Management and Staff
  • Training Management and Staff
  • Engineering Management and Staff
  • Compliance Management and Staff
  • Process Improvement Professionals
  • Process Excellence Professionals
  • Human Factors Professionals

DAY 1 : (8.30 AM – 5 PM)

Registration: 8.30 AM – 9 AM

1. Understanding the Basics of Human Error in Manufacturing

  • How human errors intersect with manufacturing regulations
  • FDA requirements and expectations
  • What FDA investigators look for during inspections
  • The most common violations found in Form 483s and Warning Letters
  • Trending violations
  • Types of common human errors

Interactive Exercise: Most common human errors within their facilities and what they uncovered. Then a list of the most common problems to be tallied to help focus the future discussion

2. Human Error and Human Factors:

  • Why administrative and management systems factor so prominently into deviations and nonconformance.
  • The role of operational controls
  • When training is appropriate and when it should stop
  • How communication gaps contribute to H.E.
  • How supervision can be one of the best human error reduction strategies
  • When is individual performance responsible for human error and when does it become a root cause

3. Psychology and Human Error:

  • How our thinking process affects performance
  • Attention, memory, and decision-making errors
  • Best practices for controlling human factors
  • How to create an organizational environment that supports human error reduction
  • Why our culture with regards to human error has to change

4. Corrective and Preventive Action (CAPA):

  • How to develop sensible corrective actions
  • Creating preventive actions that truly prevent
  • Human error prediction process and tools
  • Human error detection and recovery rate
  • Assuring the FDA your CAPA program is effective

5. Handling of OOS investigations/OOTs/LIRs:

  • Diagnostic testing
  • Hypothesis testing
  • Manufacturing investigations
  • Tools for root cause identification
  • Current regulatory concerns
  • Cause of human errors
  • Incidence handling and reporting

6. Interactive Exercise: When to do what?

Q&A and Networking: 4.30 PM – 5 PM

DAY 2 : (9 AM – 4.30 PM)


1. Human Error Reduction Techniques:

  • When is human error a human resources issue?
  • How and when to apply engineering controls to correct and prevent human error deviations
  • What to do when individual performance is the major contributor
  • Human error and documentation: from design, construction, change management and implementation.

Interactive Exercise: Identifying which techniques to apply

2. Human Error Investigation

  • Human error investigation process
  • How to gather data
  • How to perform an effective interview
  • Important steps for effective human error investigations
  • How to report issues to make sure management listens

3. Root Cause Analysis Tools:

  • Common tools and Hierarchy used in determining root cause
  • The interview process and interview techniques for human error root cause analysis
  • When to perform a process vs. procedure analysis
  • Why it is so important to do before establishing procedure revision as a CAPA for human error

4. Metrics and Human Error

  • Key Performance Indicators (KPIs)
  • Human error rate
  • 1st time pass rate
  • Overall equipment effectiveness (OEE)
  • Trending & Tracking

Q&A, Certification, Networking and Close: 4 PM – 4.30 PM



Hyderabad, India

Venue to be announced

June 20 – 21



Kalpesh Kumar Vaghela

Validation Expert

Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

G. Sundar

PharmQA Consultant

Mr. Sundar Ganesan is a quality practitioner with 24 + years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA and Japan guidelines. He assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems so that the company can succeed. Mr. Ganesan currently working as Director-Consultant at PharmQA Compliance services an independent consultant firm partners with US and Europe.

Brian G. Nadel

ex-FDA Official

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at

Payment Policy:

Payment is required to be made at least 10 business days prior to the date of the conference.

To make payment by Wire Transfer / Cheque / Credit or Debit Cards, kindly call our Customer Support to assist you with completing your registration. Payments to be made in full.

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Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 3 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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