Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Overview
Many variables, from procedures, to training to workplace environment, affect human behavior. Given the proper Failure Investigation (FI) steps and Root Cause Analysis (RCA) tools, your personnel can address human behavior and psychology of error issues in order to implement a process dedicated to investigating and fixing product and system errors.
Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years’ experience in U.S. FDA-regulated industries is one of the world’s few human error reduction experts, will discuss error categories, near root causes and root causes — along with the latest trends in human error issues.
He’ll present practical approaches and models to address human performance issues in good manufacturing practice (GMP) related environments by using a methodology to correct, prevent and avoid reoccurrence.
Webinar Takeaways
- Determine what is a causal factor of quality and compliance issues, as established in GMPs
- Gain better control over non-conformances by incorporating a failure investigation system and root cause analysis / risk management / human factors in our process, procedures and systems
- Understand the types of normal usage and system failures, including intentional and unintentional errors of omission and commission in FI and RCA
- Use basic statistical tools in harmony with the CGMPs to locate, identify and reduce / eliminate problems and root causes. using the root cause determination tool, and cognitive load tool
- Track non-conformance trends in quality and compliance
- Make predictions regarding potential non-conformances using ISO 14971 and ICD Q9 tools, diagnostic studies and FI/RCA tools
- Determine CAPA effectiveness by event reoccurrence and root cause recurrence
While non-conformances / human error may never be eliminated completely, you will come away with an understanding of the psychology of error and how to incorporate root cause and CAPA to minimize non-conformances, complaints, and CAPA inputs. Join us by registering today
Who Will Benefit
- Training managers and coordinators
- Operations
- Manufacturing
- Plant engineering
- QA/QC staff
- Process excellence/improvement/six sigma professionals
- Industrial/process engineers
- Compliance officers
- Regulatory/legislative affairs professionals
- General/corporate counsel
Industries who can attend
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty John E Lincoln
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
