ComplianceOnline

Process Validation Principles and Protocols

Instructor: Jeff Kasoff
Product ID: 701297
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Validation training will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation.

It is the goal of every manufacturing firm to maximize profit. This is often accomplished by process automation. Domestic and international regulations contain the requirements to verify that the process yields output that is both safe and effective, and meets all requirements. These requirements are also applicable to manual, "un-automated" processes. This webinar will set forth the regulatory requirements for process validation, and will also include definitions and application of applicable terminology, and hints and recommendations for the more common types of process validation. These recommendations will address the challenges most commonly experienced during validation. Also covered will be the validation technique used for processes that are already in place.

Areas Covered in the seminar:

  • What is Validation?
  • When should it be used?
  • Validation vs. Verification: Which One?
  • Different types of validation: Advance, retrospective, and concurrent
  • Protocol preparation.
  • Different types of validation.
  • IQ, OQ, and PQ.
  • Case studies and examples.

Who will benefit:

This webinar will provide valuable assistance to all companies that incorporate processes into their manufacturing, testing, or inspection processes. The employees who will benefit include:

  • R&D personnel and management
  • Process and Quality Engineers
  • QA management
  • Regulatory management
  • Consultants
  • Quality system auditors

Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

Follow us :
ComplianceOnline Medical Device Summit 2017
FDA's New Import Program for 2017 - Strict Precision

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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