GMP Complaint Systems, Adverse Event Reporting and Product Recalls

Duration: 60 Minutes
This training program will provide the regulatory requirements for complaint handling in the pharmaceutical industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint handling and product recalls. The course will also include timeline requirements associated with adverse event reporting.
GMP Complaint Systems
Instructor: Jan Warner
Product ID: 502049
Objectives of the Presentation
  • Understand what complaints and recalls are
  • What are the FDA requirements for complaints, adverse events and recalls
  • What are the documentation requirements
  • What are the reporting requirements
  • Requirements for a complaint system
  • Reporting adverse events
  • Requirements for a recall system
Why Should you Attend
This webinar will describe the key elements and requirements for a compliant system and a system for conducting recalls. Anyone in the pharma or FDA regulated industries must attend.

Areas Covered
  • GMP requirements for complaint documentation and management
  • GMP standards for an effective recall system
  • To identify the key issues in product complaint and recall handling
  • To understand the specific requirements for organization, procedures and resources
  • To understand and develop actions to resolve current issues applicable to you
Who will Benefit
  • Those working in the FDA compliant industries such as pharma, medical devices and biotech
  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Quality Control Professionals
  • Regulatory Affairs Professionals
  • Complaint Handling Professionals
  • Quality Engineers
  • Service Technicians and Engineers
  • Manufacturing and Design Engineers
  • Process Development Personnel
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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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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