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Process Validation
Offered via Instructor-Led (1 day)
Plan, execute, document, and maintain effective process validation.
No upcoming classes scheduled.

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About

This one-day course gives quality and operations professionals a practical framework for validating processes whose results cannot be fully verified through subsequent inspection or testing. Participants plan, execute, document, control, and monitor validation using API-focused examples.

This one-day course gives quality and operations professionals a practical framework for validating processes whose results cannot be fully verified through subsequent inspection or testing. Participants plan, execute, document, control, and monitor validation using API-focused examples.

Description

Process validation provides objective evidence that a process can consistently achieve its intended results. This Instructor-Led course explains API requirements and practical validation methods, from planning and protocol execution through documentation, monitoring, and change control. Participants work with examples involving welding, painting and coating, bolt pretensioning, and other critical processes, then apply the concepts in a case study and workshop.

Learning Objectives​

  • Explain the purpose of process validation and applicable API requirements.
  • Determine when a process requires validation.
  • Develop a validation plan with defined responsibilities, criteria, and records.
  • Execute and document validation activities.
  • Control and monitor validated processes throughout their lifecycle.
  • Apply validation concepts to practical manufacturing and service examples.

Prerequisites​

Familiarity with quality management systems and either API Spec Q1 or API Spec Q2 is recommended. No prior process validation training is required.

Teaching Methods

Summary Agenda

  • Fundamentals of Process Validation and API Requirements
  • Validation Planning, Execution, and Documentation
  • Control and Monitoring of Validated Processes
  • Common Processes to Validate and Practical Examples
  • Case Study, Workshop, and Assessment

Successful Completion​

Instructor-Led participants successfully complete the course through active participation, completion of the validation workshop and case study, and successful completion of the course assessment.

Class Daily Schedule

Instructor-led classes typically follow this schedule, unless otherwise stated on the specific class:

Class Length
1 day
Lunch
~12:00 CST (Duration 60 minutes).
Typical Start and End Times
DayFromTo
108:30 CST16:00 CST

Upcoming Classes

There are no Upcoming Classes available at this time. Check back or send us a request.

Self-Paced Online

There are no Self-Paced courses available at this time. Check back or send us a request.

Terms and Conditions

Payment Options

Credit Card/E-check: Register and Pay online via credit card or e-Check directly from your bank account or debit account.

Bank Wire Transfer/ACH/Purchase Order (PO): We accept payment by Bank Wire Transfer, ACH, or PO. If you’d like to use either of these payment methods and request an invoice, please email us at [email protected].

NOTE: Payments made by Bank Wire Transfer, ACH, or PO will require an additional processing fee in the amount of USD $25, that will be included on your invoice.

Registration Transfer Policy

Registrations can be transferred to other participants or to other courses provided by Mireaux Management Solutions 30 days prior to the course start date.

  • Registration Transfers must be submitted in writing to [email protected].
  • There will be a 15% administrative fee applied to each registration transfer.
  • Payment for any difference in price, including the 15% administrative fee, will be required at the time of transfer to other courses of equal or greater value of the original paid amount.
  • Registration Transfers to a course of lesser value are allowed but are not eligible for refunds.
  • Registration Transfers are not allowed within 30 days of the course start date.

Cancellation Policy

Cancellations must be submitted in writing to [email protected] 30 days prior to the course start date in order to receive a refund, minus a 15% administrative fee. Cancellations are not allowed within 30 days of the course start date.

Discount Policy

Limit one discount per purchase. discount applicable to online purchases only.

Exemplar Global Training Records

For courses recognized by Exemplar Global, participants’ names, email addresses, course names, training locations, and training dates will be shared with Exemplar Global for training-record verification and access to applicable graduate benefits. Exemplar Global may contact participants about their training records and those benefits.

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