Duration: 60 Minutes


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The webinar will discuss basic/key requirements for writing SOPs, recording data, completing forms and other basic documentation requirements for the GMP compliant company. Furthermore, the current industry requirements for recordkeeping will be discussed.

In this webinar:

  • You will be shown the benefits of good documentation practices in the GMP environment
  • You will gain a knowledge base for controlling and handling documents in a GMP compliant environment
  • You will have a better understand the basic requirements that FDA seeks for all records, documents, forms and procedures to meet GMP requirements
  • You will be guided on how to ensure the quality and consistency of processes/activities/manufacturing


Areas Covered in the Session :

  • Good Documentation Practices Do’s and Don’ts
  • cGMP requirements for changing and controlling entries into documents
  • Archiving of records
  • Current industry practices for GDP
  • Interactive Q&A Session

Who Should Attend:

  • Quality Assurance Professionals
  • Quality Control Professionals
  • Regulatory Professionals
  • Pharma/Medical Devices/OTC Cosmetic Manufacturing Teams
  • Pharma/Medical Devices/OTC Cosmetic Packaging Teams
  • Pharma/Medical Devices/OTC Cosmetic Subcontractors
  • Contract Testing Laboratories
  • Owners/Presidents of GMP regulated companies

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