Proactive Internal Auditing -The Key to Establishing, Maintaining, and Improving Quality Systems

Duration: 60 Minutes
Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization's operations. Conducting internal audits in the pharmaceutical and medical device industries is a key element of a quality management system. It is also a regulatory requirement and therefore a company must have a documented and systematic approach to conducting internal audits. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company's compliance with pharmaceutical USFDA - GMP regulations.
Proactive Internal Auditing
Instructor: Jan Warner
Product ID: 506392
Objectives of the Presentation
  • Regulatory requirements for internal auditing
  • Benefits of the Internal audit system
  • Elements of the internal audit system
  • Conducting the internal audit
  • The audit report
  • Corrective actions
Why Should you Attend
As regulatory agencies like the FDA (America), PMDA (Japan), EMA (Europe), ANVISA (Brazil), and CFDA (China) continue to increase the amount of regulation for the Life Sciences industry, companies must place an increased importance on internal audit protocols as well as on respond mechanisms. This can become exceedingly complex as companies expand commercial markets and need to comply with additional market regulators. Companies who manufacture products, such as drugs for human consumption, are heavily scrutinized by regulators; the slightest mishap can incur serious penalties.

This webinar will teach and describe the fundamentals and key elements for creating and maintaining an internal auditing system in the pharmaceutical and medical device industries.

Areas Covered
  • Training of auditors
  • Creation of documentation surrounding an internal audit
  • Conducting internal audits
  • Responding to internal audits
Who will Benefit
  • Executives and Managers of Pharma and Biotech Companies
  • Process and Manufacturing Engineers
  • Quality Assurance Personnel
  • Regulatory Affairs Professionals
  • Quality Control Lab Personnel
  • Quality Engineers
  • Research and Development Scientists
  • Biologists and Microbiologists
  • Chemists and Chemical Engineers
Topic Background
Development of Internal Auditing for a tool to monitor and measure compliance to regulatory requirements in the pharma and medical device industries
$375
Recorded Session for one participant
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  • 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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