Subcontractor Auditing for Pharma and Medical Device

Duration: 60 Minutes
This webinar will discuss the regulatory and compliance requirements for auditing subcontractors used to manufacture components and finished goods. Specific guidance will be delivered for how to audit subcontractors. Procedures, documents and other records will be discussed. In addition, the tools used such as checklists will be discussed. Furthermore, the auditing techniques such as observation and questioning will be reviewed.
GMP Training
Instructor: Jan Warner
Product ID: 501224
Objectives of the Presentation
  • What types of subcontractors should be audited
  • Subcontractor audit programs and procedures
  • Regulatory requirements (FDA)
  • Audit process
  • How to write an audit report
  • Follow-up and corrective actions
Why Should you Attend
Personnel working in the Pharma and Medical Device industries, who use subcontractors to manufacture components and finished products must attend this webinar to understand the regulatory requirements.

Areas Covered
  • Auditing and compliance
  • FDA requirements
  • Audit procedures
  • Managing subcontractors
  • The relationship between purchasing and quality
Who can Benefit
  • Medical device manufacturers
  • Pharmaceutical manufacturers
  • OTC product manufacturers
  • Subcontractors
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Jan Warner is an accomplished, broad-based regulatory, quality and compliance professional with over 25 years of experience in the following products and industries: pharmaceutical, medical device, OTC and personal care, homeopathic drugs, dietary supplements and cosmetics. He has held numerous upper management responsibilities in quality assurance, compliance and quality control at companies such as Pall Corporation, Lâ??Oreal, Luitpold Pharmaceuticals, Axiom Pharmaceuticals, Johnson and Johnson and Nobel Biocare. He is the owner of IQA Consulting Services; a niche provider of quality and compliance services to the FDA and similarly regulated industries. Jan has extensive experience working for Fortune 500 as well as start-up companies.
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