Duration: 60 Minutes


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This webinar will explain the basic principles of SOPs and Documentation required for the successful and compliant function of a quality system in the pharma and medical device industries. Particular emphasis will be the specific requirements set out in 21 CFR Part 210/211/820 and how these requirements can be met.

You will learn the current industry standards for creating and maintaining SOPs and documentation in compliance to GMP requirements.


Areas Covered in the Session :

  • SOP and documentation requirements
  • Training requirements
  • SOP and document archiving
  • SOP creation and obsoletion traceability
  • Interactive Q&A Session

Who Should Attend:

  • Quality Control Departments
  • Quality Assurance Departments
  • Production Departments
  • Purchasing Departments
  • Operations Departments
  • HR Departments

Course Director: JAN L. WARNER

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. 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.

His expertise encompasses the following:

  • Product types: Pharmaceuticals (Rx and OTC), medical devices, IVDs, veterinary products, injectables, cosmetics, chemical ingredients and actives, and biologics
  • FDA regulated product manufacturing, packaging, Quality Assurance, Laboratory Operations and Regulatory Affairs
  • Creation, implementation and management of Quality Systems for the following standards: GXP, ISO 13485, ISO 22716, ISO 15378, ISO 9001, ICH Q7 and EFfCI
  • Manufacturing, Quality and Complaint investigations
  • Training, technical writing and SOP development
  • CAPA and change control management
  • FDA Field Alerts, 483s, recalls and consent decree remediation
  • Supplier, API, contract manufacturing and packaging, internal and third party auditing