PDA 576 Root Cause Investigation for CAPA

Washington, DC
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Root Cause Investigation for CAPA is a two-day training on a proven methodology ideal for investigating any performance change. 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, 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 a trainer case study, the participants will immediately apply their learning on their own case study (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.

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. 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.

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

PDA Quality and Compliance Training Courses
PDA Regulatory Training Courses

  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

Standard Pricing

Standard Member Price

$1,999

GovernmentMember Only

$1,399

Health AuthorityMember Only

$1,399

AcademicMember Only

$1,399

Non-Member

$2,399

See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Day 1

Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast and lunch will be provided.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

The Renaissance Washington, DC is the headquarter hotel for the 2023 PDA/FDA Joint Regulatory Conference!

Rate: $331 USD for single/double occupancy, plus state and local taxes
Cut-Off Date: Friday, 18 August 2023 (after this date the discounted PDA rate is no longer guaranteed)
Check-In: 15:00
Check-Out: 12:00

Reservations

Phone: +1 (800) 228-9290, make sure to refer to group code PDAN for the discounted conference rate
Online:
Click on the reservation link above

Individual Cancellation

All cancellations must be received by 23:59 local time 72-hours before arrival to avoid a penalty of one night room and tax. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.


Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. From museums to entertainment, this is the perfect base for exploring downtown DC. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi. Steps from shopping, dining, nightlife and sports, this hotel places the best of DC at your doorstep. Expect the extraordinary at Renaissance Washington, DC Downtown Hotel.

How to Get Here
By Air The airports closest to the Renaissance Washington, DC Downtown hotel are Reagan National Airport (DCA, 4.6m/7.4km), Dulles International Airport (IAD, 27.8m/46.2km), and Baltimore-Washington International Airport (BWI, 32.1m/51.7km).
By Car The Renaissance Washington, DC Downtown hotel is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($35+/day) and valet parking ($61+/day) are available.