"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Effective root cause investigation for Life Science
Ways to conduct better investigations and corrective actions
Problems like deviations and failures are a fact of life but individuals and organizations that understand what happened and why are in a much stronger position to establish corrective actions to reduce the likelihood that the event happening again.
Develop the skills and techniques to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence.
This two-day workshop examines a defined, logical process that can be applied to investigations that are performed in the drug, biotech, and medical device industries. Tools like data collection sheets, checklists, and interview worksheets, based on some of the best practices in the pharma industry and beyond, and provided and used. A variety of problem solving, interviewing, and data collection techniques will also be examined.
"Human error" will be discussed along with ways to more fully understand what really caused or contributed to the incident and how those factors can be effectively addressed.
Participants will also have the opportunity to see the importance of a team approach when doing an investigation. Teams will review and critique an investigation report and discuss risk-based alternatives when a definitive root cause cannot be determined.
Who should attend:
Those who conduct, review, or approve investigations in development, quality assurance, laboratories, operations, technical services, and maintenance/engineering.
- Discuss the expectations that GMP regulatory authorities have of investigations, CAPAs, and investigation reports.
- Differentiate between six different accident/incident models and how they can be applied during an investigation.
- Differentiate between root cause, contributing cause, and proximal cause.
- Discuss why human error is not a valid root cause.
- Given an incident, develop an investigation plan.
- Discuss the relationship between root, contributing, and proximal causes to corrections and corrective actions.
- Discuss a model that can be used to illustrate multiple layers of control and mitigation.
- Using a guideline, evaluate an interview.
- Identify four different audiences of investigation reports and what each is expecting to see in an investigation report.
- Discuss options of what can be done when a definitive root cause cannot be identified.
- Given an investigation report with deficiencies, identify ways to improve the report.
Detailed course outline - Click here (open/close) »
- Activity: Reasons for and benefits of investigations
- Patient safety
- Quality reasons
- Business reasons
- Investigations, Q10, and process understanding
- Regulatory expectations
- Regulatory agency findings, FDA observations, and Warning Letters
- Definitions and models
- Activity: Important definitions
- Six accident models: The value of models and how they can be used in investigations
- What about “human error”?
- Applying risk-based thinking to investigations, part 1
- 14 steps to better investigations
- The big picture
- Worksheets and data collection
- Activity: Making the case for an investigation team
- The investigation plan
- The importance of the “golden hours”
- Conducting the investigation: tools to help identify the causes and contributors
- Flow charting, process mapping
- Fishbone / cause-effect diagrams
- Fault trees
- Effect diagrams
- Five whys
- Change analysis
- Activity: Small group work—Your experiences with the tools
- Interviewing skills
- What makes for a good interview?
- The difference between an interview and an interrogation
- How the brain works: the problem with re-telling and re-telling the story
- Activity: Critiquing an interview
- Working with subject matter experts
- How experts “do it” – intuition and analysis
- Caveats when working with experts
- Activity: factors that can affect intuition
- What if you can’t find the root cause?
- Demonstrating diligence
- The known/unknown matrix worksheet
- Increasing detection and protection to reduce risk
- Putting it together: creating an investigation plan
- Activity: Writing (or re-writing) a procedure
- Activity: Reviewing a procedure and giving feedback
- Assessing and managing risks related to investigations
- Key definitions
- The risk management process
- Formulating the risk question
- Tools for assessing risk
- Using RA/RM in the investigation process
- Corrections and corrective actions (and preventive actions)
- How they differ, what they include
- Think Swiss cheese!
- Actions that add/don’t add value
- Actions to consider when “human error” is involved
- Activity: What would you do? Finding new solutions
- Writing it up: key elements in a report
- Activity: Four groups who read reports – and what they want to know
- How much? How long?
- What to include
- One purpose of the report: reducing fear, reducing risk
- "Writing comes easier when you have something to say"
- Suggestions and hints for better reports
- Critical thinking and writing
- Activity: Finding the good (and the bad) in a sample report
- Your investigation system: what will you take back and do differently?
- Activity: small group discussions and idea sharing
- Activity: small group discussions and idea sharing
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
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"Very satisfied with the course and the course leader, it met all my expectations. I will recommend this course to my collegues!"
"The organization was excellent; I personally appreciated the enthusiasm of the course leader and the applicability of his methods/material. We were provided with good material and sources for further investigation. great, interactive course. highly recommend!"
Pharmaceuticals, API, Biopharmaceuticals and Medical Device
US and EU
James L. Vesper, PhD
Date, location and venue:
6-7 May 2020, Copenhagen
Postponed to 8-9 October, Copenhagen
due to covid-19
Venue (central Copenhagen) will be confirmed soon.
This course is offered in-house.
Click here for more info and inquiry form.
8.30-16.30 (Registration 08.00-08.30)
Register by 27 Aug - Save 1 500 DKK (€ 200)
Until 27 Aug 13 780 DKK (€ 1 850)
From 28 Aug: 15 280 DKK (€ 2 050)
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
3-7 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 14 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.