This instructor-led live training webinar will discuss regulatory requirements for detecting, correcting and preventing human errors in manufacturing and laboratory environments as well as 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, retraining and rewrite of SOP is top the list. 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 live training webinar 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.

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.

Regulations that will be Covered:

Each country has its own specific set of regulations. Below are examples of regulations that are applicable:

• Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA.
• Health Canada regulations for pharmaceutical and biotechnology products including appropriate annexes such as 1, 2, 3, 18.
• EMA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.
• International Conference on Harmonisation Quality Series Q1 through Q10 for USA, EU, Japan and other countries.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Understand why human errors contribute to deviations and discrepancies,
What do the regulators say,
How to probe deeper into root cause and contributing factors,
CAPA's that are ineffective,

11:30 AM 10 Minute Break

                How to eliminate human error as a root cause,
Deeper investigations yield more effective CAPA's,
Knowing that your CAPA's will be effective,
Tracking effectiveness,
How companies get it wrong,
Conclusions,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

• A copy of the presentation slides
• A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Quality Assurance Personnel
• Quality Control Personnel
• Supply Chain and Logistics Managers
• Regulatory Affairs Professionals
• Process Development Scientists and Management
• Manufacturing Management and Scientists
• Project Managers working in the CMC arena

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.