Internal Quality Audit: Identifying Corrective and Preventive Actions

Speaker

Instructor: Ronald Schoengold
Product ID: 700585

Location
  • Duration: 75 Min
This Internal Quality Audit training is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.
RECORDED TRAINING
Last Recorded Date: Aug-2007

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why Should You Attend:

Conducting internal quality audits and using the findings to make needed improvements to the quality system are regulatory requirements. Case studies illustrate typical audit findings and how they can be addressed by the audit program. Internal audits are designed to detect nonconformances that need corrective action and potential problems that require preventive action. Significant audit finding should be captured in the CAPA system which also provides a mechanism for resolving issues and tracking outcomes. Well trained auditors are an essential part of the quality system, and provide assurance that the quality system is being maintained. The internal audit program, consistently applied, provides the company with an increased measure of product quality.

Learning Objectives:

  • Understanding regulatory requirements
  • Committing adequate resources to the internal audit program
  • Maintaining separation and cooperation between operations and quality auditors
  • Opening CAPAs on significant issues
  • Tracking problem resolutions and outcomes

Areas Covered in the Webinar:

  • Why we perform internal audits
  • Practical guidelines in planning internal audits
  • Auditor qualifications and training
  • Effective quality audits
  • Audit reports and files
  • Communicating audit findings
  • Opening CAPAs
  • Case studies
  • Audit Checklist

Who Will Benefit:

  • Executive Management
  • Internal Quality Auditors
  • Quality Managers
  • Regulatory Affairs Managers
  • Marketing Managers
  • R & D Managers
  • Program Managers
  • Project Managers
  • Product Development and Engineering Managers

Instructor Profile:

Ronald Schoengold, has been an active contributor to the medical device, pharmaceutical and biomedical environment for over 45 years. As a consultant to both large and small companies, he offers expert advice on quality systems, regulatory submissions and resolution of regulatory and quality problems. He is also an experienced auditor in clinical research, supply chain and manufacturing (GMPs). Ron is certified in regulatory affairs and has a proven record of accomplishment for integrating quality and regulatory requirements with technical, organizational and business development needs. He offers critical advice on the effective commercialization, support and maintenance of medical products and services and is an advisor to the National Institutes of Health, Commercialization Assistance Program, assisting companies awarded SBIR grants. Ron has published, presented or contributed to more than 16 scientific publications including a book chapter on point-of-care testing. He holds 8 patents related to point-of-care diagnostics.

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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