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CAPA for Medical Devices & Pharma

Master the implementation of CAPA systems and ensure compliance with FDA regulations in the medical devices and pharmaceutical industry. Gain the knowledge and tools needed to analyze root causes, improve quality data, and drive profitable results. Ideal for quality, compliance, and regulatory professionals in the field.

  • Intermediate
  • 18 and older
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  • 28 Lord Road, , Marlborough, MA
  • 18 hours over 2 sessions

Start Dates (0) $1,095/person

No upcoming dates are currently available.

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Class Description

Description

This course has been designed to learn CAPA (corrective and preventive action) system, its effective implementation and generate improved results (CAPA is a requirement from the FDA\'s Quality System Regulation), understand its essential current / future requirements, and assist in merging gaps to increase compliance and generate profitable bottom-line results.

Course Benefits

Participants will understand the elements of an effective CAPA program, latest FDA trends, origins of data (internal/external), cost-effectiveness, effective corrective action tools for routine problems/root cause analysis, and why regulatory agencies add preventive action in clause/requirements

Prerequisites:

Medical Device background

Topics Covered:

  • Introduction / Background
  • CAPA definition
  • CAPA application for medical devices/pharmaceuticals
  • CAPA implementation
  • Quality data - sources
  • Root Cause Analysis
  • Effective implementation
  • Reporting and Tracking
  • Corrections
  • Removals
  • Communication

Who Should Attend?

The target audience for this course consists of executives, top management who work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations).

Refund Policy

REFUND POLICY: (AS PER M.G.L. CHAPTER 255, SECTION 13K)

  1. You may terminate this agreement at any time.
  2. If you terminate this agreement within five days you will receive a refund of all monies paid, provided that you have not commenced the program.
  3. If you subsequently terminate this agreement prior to the commencement of the program, you will receive a refund of all monies paid, less the actual reasonable administrative costs described in paragraph 7.
  4. If you terminate this agreement during the first quarter of the program, you will receive a refund of at least seventy-five percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  5. If you terminate this agreement during the second quarter of the program, you will receive a refund of at least fifty percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  6. If you terminate this agreement during the third quarter of the program, you will receive a refund of at least twenty-five percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  7. If you terminate this agreement after the initial five-day period, you will be responsible for actual reasonable administrative costs incurred by the school to enroll you and to process your application, which administrative costs shall not exceed fifty dollars or five percent of the contract price, whichever is less. A list of such administrative costs is attached hereto and made a part of this agreement.
  8. If you wish to terminate this agreement, you must inform the school in writing of your termination, which will become effective on the day, such writing is mailed.
  9. The school is not obligated to provide any refund if you terminate this agreement during the fourth quarter of the program.
In any event where a customer wants to cancel their enrollment and is eligible for a full refund, a 5% processing fee will be deducted from the refund amount.

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Quality & Productivity Solutions, Inc

Quality & Productivity Solutions, Inc. is an international consulting and training firm that partners with clients to improve their processes, products, services, and overall performance through educational courses. Their QPS Institute offers a wide range of training courses for professionals at all stages of development, including public training for personal development, corporate training for businesses, and custom training for specific needs.

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Quality & Productivity Solutions, Inc
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