3-Hour Virtual Seminar on GMP Auditing for Active Pharmaceutical Ingredients (APIs) and Excipient Suppliers

Good manufacturing practice (GMP) is an internationally recognized set of regulations to ensure the quality, safety and efficacy of medicines and healthcare products for humans and animals. Compliance is regulated by nationally assigned Competent Authorities, for example: HC (Canada), FDA (US), TGA (Australia), MHRA (UK) and EMA (Europe). Other countries where these rules have been formally adopted or supported are South Africa, Asia, and Japan.

This course is to provide GMP auditors with background knowledge and skills to effectively plan, conduct and report audits of API and excipient manufacturers. It is geared towards a focused and systematic approach to auditing as well as consistency in reporting observations.

Areas Covered in the Session :

  • Introduction and definitions
  • The Regulations
  • API route of synthesis and when to apply GMP
  • Pre-Audit – things to consider
  • Check lists
  • API Audits
  • Excipient Audits
  • Post Audit Activities
  • Audit Findings
  • Examples
  • Interactive Q&A Session
Who Should Attend:

  • Pharmaceutical Manufactures and Contract Manufacturers
  • Start-up Biotech Companies
  • Specialist API and excipient manufacturers and suppliers
  • Veterinary medicines manufacturers
  • Quality Assurance Departments
  • Quality Control Departments
  • Qualified Pharmaceutical Auditors
  • Supplier Auditors
  • Trainee Auditors

FDB3288

Dr Madeleine S. Fairweather

Dr Madeleine S. Fairweather Ph.D., MRSB, is a freelance GMP course writer and presenter. Her background experience was gained over 15 years in quality assurance of biological and botanical APIs. She has specialist knowledge of therapeutic antibodies, blood and plasma, as well as recombinant DNA vaccines, siRNAs and materials requiring special handling. She has been involved in technology transfer and ongoing auditing of API suppliers for over ten years which has taken her throughout Europe, to the USA as well as throughout Australasia.

She has successfully ensured the manufacturing quality of active substances as well as final products, and has guided sponsors and suppliers to achieving licenses for global markets. Madeleine also provides specialist advice on importation testing and conducts supplier audits.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.