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Root Cause Investigation for CAPA

Jul 22 - Jul 23, 2020
Bethesda, MD

  • Education
  • The Americas

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Root Cause Investigation for CAPA teaches a proven methodology ideal for investigating any performance change. Examples: change in the performance of a product (tangible or intangible), machine or equipment, work process or system (physical or virtual), escalated customer complaints, etc.

Based upon 40+ years’ experience, this science-based methodology integrates problem solving techniques from Total Quality Management (TQM), Six Sigma, Kaizen, DMAIC (define, measure, analyze, improve, control), 8D, as well as other techniques to identify:

  • Technical root cause(s): the change(s) that occurred
  • Systemic root cause(s): system failures that allowed the change(s) to occur
  • Corrective and/or preventive actions: restore performance to previous levels
  • Control plan: prevent recurrence

The participants learn the seven-step root cause investigation methodology through hands-on application. After each step is presented leveraging a trainer case study, the participants immediately apply the concepts on their own case study (which is based upon a real life investigation).

Participants receive an Investigation Roadmap that details the methodology and suggest appropriate tools. They will also be emailed a set of electronic templates. These tools guide the investigator through the methodology and provide the basis for documentation.

Upon completion of the training, participants will be able to immediately, effectively, and efficiently apply the methodology to identify root causes and restore performance, saving valuable time, resources, and reputation.

For more options and/or related training courses, please visit the page(s) below.

PDA Quality Assurance Training Course Series


  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.


Rob Weaver
Rob Weaver
Weaver Consulting

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Apply a 7-step investigation methodology to determine the root cause of a technical problem
    2. Identify the technical root cause (the change) and any systemic root causes
    3. Implement effective corrective / preventive actions
    4. Develop and implement a control plan to assure you do not have this issue again
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who conduct or participate in root cause investigations for all medical devices and pharmaceuticals.

    Manufacturing, Quality Assurance, Quality Control, Facilities, Engineering, Project Management, Supply Chain

    Manager, Supervisor, Specialist, Analyst

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.


Registration Fees

Early Registration
Registration Type Price By June 5, 2020
Member $1,889
Non-member $2,267
Gov't/Health Auth./Academic* $1,469

Regular Registration
Registration Type Price After June 5, 2020
Member $2,099
Non-member $2,519
Gov't/Health Auth./Academic* $1,469

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Jun 20, 2020, no fee will be charged. After Jun 20, 2020, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Jun 20, 2020, a full refund will be given minus a $200 fee. After Jun 20, 2020, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.


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Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
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