Pharma / BiotechMedical Device
Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This course highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis.
The primary objective of this course is to recognize the value of conducting proper root cause analysis and documenting failure investigations. Emphasis is placed on the application and practical, hands-on aspects of how to facilitate root cause analysis. Additionally, the course will provide attendees with the principles and techniques involved in identifying failures and deviations, categorizing problems, assigning responsibility and tracking team activities.
Additional benefits of this class include:
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
This Root Cause Analysis training course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP environment, specifically Root Cause Analysis for CAPA. These include, but are not limited to, positions in Manufacturing and Packaging, Quality Assurance/Quality Control, and those support groups who initiate, conduct and/or manage investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment. This course will be practical in its application and particularly valuable to those newer to this field or those who wish to refresh their knowledge of root cause analysis and investigative techniques.
Course Introduction and Expectations
Regulatory Expectations for Investigations
Investigation Process Overview
Skills and Tools of an Effective Investigator
(Re) Introduction to Root Cause Analysis (RCA)
Defining the Deviation
Identifying Root Cause
Corrective and Preventive Actions (CAPA)
Management of the investigation
Members of the Investigation Team
Wrap Up and Review
This course provides clarification of regulatory expectations and guidance, and the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and notification through documentation.. Participants will practice root cause analysis techniques and identify corrective and/or preventive actions towards successful remediation and closeout.
Attendees will gain a perspective of effective interviewing and writing skills, discuss common pitfalls, and develop tips and techniques for thorough investigations and elimination of recurring failures and deviations. Additionally, attendees will learn through hands-on activities such as group discussions and case studies tailored to regulated industries.
"This was one of the best training courses I have ever attended. The material is very useful in my work, even though I don’t do many investigations." JoAnn B., Assoc. Manager Doc Control, Gilead
"The Course Director is a very good instructor and kept the class engaged for 2 days. Lots of opportunity to practice what you learn. I feel I have a better understanding of how to use the tools." Duval C., Sr. Manager – Quality, Gilead
"The course was great, and I learned several valuable tools to help with my daily work tasks. Our instructor was very good at keeping the room "alive", and allowing us to figure out the problems for ourselves with some guidance. I would recommend this course to anyone in the industry that has dealings with root cause and CAPA." Carl S., Manufacturing Supervisor, Thermo Fisher Scientific
"The course was well-planned, timed and executed. The instructor was able to keep the group engaged by performing multiple group activities (case studies, projects). The instructor also fielded the groups' questions effectively and was able to relate the course material to real time issues concerning MTF. I took away the important lesson of drilling down to the true ROOT cause, defining the scope, and not jumping ahead before truly defining the root cause or trul ruling out any additional scenarios." Greg N., Assoc. Manager Contracts & Value Analysis, MTF
"This training was an eye opener. I am walking away from this, feeling like MTF will find the true root cause 90% of the time – instead of 10%. Thank you!" Cindy H., QA Compliance Specialist, MTF
"Would not change anything about the course! Great job!!" Jim. D., Sr. QE, Bruker Daltonics
"The Course Director was very knowledgable and supportive. He was willing to take extra time to help everyone and was a great presenter. Good use of time and a mix of activities and lecture." Jaclyn F., Validation Engineer, Genzyme
"Excellent delivery of information with consistent methodology of events/topics." Ronald Z., Production Sub-assembly Supervisor, Bruker Daltonics
"The class is perfect! The Course Director provides good examples and the class was very interactive. The instructor is very experienced and brings great industry examples to make us understand it better." Hitesh B., Industrial Engineer, Forest Laboratories
"Good overview of the tools, processes, and regulatory requirements of the investigation (CAPA) process. I will go away with a different interpretation and make some changes and improvements to our current CAPA process - with this, will also make some personal changes." Wayne A., Plant Manager, Rockline Industries
"This course has the information to take you to the next level. The interactive nature of the course was fantastic. CAPA and Root Cause can effect each company at a different level, and the unique perspectives provided by the Course Director were excellent. I am extremely pleased with the knowledge that I am taking back with me." Donna C., Manager of QA and RA, Positron Corporation
"Great instructor! Well schooled. Teaches well. Personable. Keeps the class interesting." Mike P., VP, Director of Operations, Celeste Ind. Corp
"The case studies were excellent and working in a team environment was a great exercise. The Course Director blended the right amount of interaction between attendees made the training interesting and beneficial. It is a great course for introducing CAPA and RCA analysis. I recommend the course to any GMP compliance related personnel." Jennifer L., GMP Compliance Manager, Pfizer
"The Course Director was superb. I really enjoyed the group project parts of the course." Darby O., QA Associate, Dendreon Corp.
"This was a fantastic course! It not only simplifies the CAPA process, it provides enough information to implement a CAPA system or improve on existing CAPA system." Sandra L., Sr. Manager, QC, Hollister Stier
"I definitely enjoyed this course a lot. I learned new material even after working in the pharmaceutical industry for over fifteen years! Thank you!" Jose C., Quality Specialist, Amgen
Regulatory aspects of investigations and corrective/preventive actions from pharmaceutical, medical device and biological regulations are presented. However, the course material is presented, demonstrated and practiced so as to be applicable to any industry.
True - the majority of deviations are detected as a result of human error. However, what we need to determine is what caused the error. This course demonstrates (and allows participants to practice) how to reveal what was the underlying source (root cause) that caused the human (or material or machine) error to occur.
While it may appear that way, the material is presented so that any organization can adopt and adapt the principles, techniques and roles of the investigation process and root cause analysis. The "take home" of the course is utilizing all of these elements in a way that streamlines your investigation process and enables your company to conduct them in a timely fashion.
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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