ComplianceOnline

Auditing Failure or Process Deviation Investigations

Instructor: Michelle Sceppa
Product ID: 701128
  • Duration: 60 Min

recorded version

$149.00
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
Last Recorded Date: Feb-2009

Training CD / USB Drive

$350.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This FDA Inspection training will examines the audit process and how to manage Process Deviation Investigations.

Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause U.S. Food and Drug Administration (FDA) inspections.

Areas Covered in the seminar:

  • Key elements of the audit process.
  • How to correct audit observations for incomplete reports.
  • Examine the steps necessary to ensure completion of various types of investigations.
  • Various tracking systems to ensure proper follow-up.
  • Ensure that SOPs and work instructions are updated to reflect any changes.
  • Obtain timely approval of the investigation report.
  • Anticipating and avoiding common barriers and obstacles.

Who will benefit:

This webinar will provide direction to perform audits of the Process Deviation and/or Failure Investigation System.
  • Managers
  • Supervisors
  • Associates
  • Quality Assurance
  • Quality Control
  • Compliance and Manufacturing

Instructor Profile:
Michelle Sceppa, is the Principal at MSceppa Consulting, an establish Consulting firm and is in its 12thth year in the Industry that specializes in quality systems for Pharmaceutical and Biotechnology interests. MSceppa Consulting has implemented and managed Preclinical, Clinical, and Manufacturing Quality Assurance Programs for numerous clients. As the lead auditor, MSceppa Consulting has conducted and managed more than 400 internal and external vendor audits for Drug and Biologic firms in the US and Europe. MSceppa Consulting is knowledgeable in the details of compliance with all U.S. Federal Regulations-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) for Drugs, Biologics and Medical Devices.

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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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