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Parenteral Drug Association Connecting People, Science and Regulation ®

Root Cause Investigation for CAPA

May 01 - May 02, 2018 |
May 02, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

Root Cause Investigation for CAPA is a two-day training teaching 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), 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.

On day one, the participants are introduced to the seven step root cause investigation methodology. An Investigation Roadmap is provided to guide the participants through the steps and suggest appropriate tools. After each step is presented leveraging an instructor case study, the participants immediately apply the learning on their own case study (which is based upon a real life investigation).

On day two, several hours are devoted to strengthening the participants’ skills leveraging the methodology through practice on another, more complex, real life case study. As the participants work on this case study they will compare their work with that of the investigation conducted by the real team.

Participants will be emailed a set of electronic templates. These templates, plus the investigation roadmap, guide the investigator through the methodology and provide the basis for documentation.

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

Who Should Attend

The training is appropriate for professionals who conduct or participate in root cause investigations from all industries, particularly those that are highly regulated (medical device, pharmaceutical, aerospace, defense, food, automotive, financial services, etc.), or organizations maintaining one of the various ISO certifications. Alumni of this program typically (though not exclusively) have a background in: quality, risk management, regulatory affairs, compliance, manufacturing, product development, CAPA, supply chain & purchasing, production, engineering, project management, R&D, fraud management, and more.

Upon completion of this course, you will be able to:

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



On or before March 19, 2018

After March 19, 2018


On or before March 19, 2018

After March 19, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by April 2, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Rob Weaver, President, Weaver Consulting, LLC

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #576 | ACPE #0116-0000-14-072-L04-P | 1.2 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 12 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 12 PDHs.