Microbiology Contamination of Non-Sterile Oral Drug Products

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Jan 24, 2017
60 minutes
Product Description

The Historical Background of Microbiology Contamination Guidance for Non-Sterile Oral Drug Products

This webinar by expert speaker Dr. Dave Elder will provide insight into the historical background to the introduction of the microbiology contamination guidance for non-sterile oral drug products. You will learn about different risk assessments and the holistic nature of control strategies and the different approaches that can be taken.

Also, you will gain insight into the concerns around objectionable organisms as well as the issues associated with these organisms. Lastly, the session will explain the implications of change control on established products.

Session Highlights:

  • Why was this guidance introduced?
  • What were the issues from an historical perspective?
  • How to undertake a risk assessment to identify potential microbiological contamination issues
  • Impact of dosage form/route of delivery on risk assessment
  • How to introduce control strategies to manage likely residual microbiological contamination issues
  • What is the impact of this guidance on established drug products, i.e. change control?
  • What are the testing implications?
  • What constitutes an objectionable organism? What are the issues?
  • Industry Guidance
  • Problem Statement
  • Risk Assessment (API, Excipients, Process, Pack)
  • Control Strategies (API, Excipients, Process, Pack)
  • Regulatory Views
  • Testing Implications
  • Objectionable Organisms
  • Areas of uncertainty
  • Conclusions

Who Should Attend

The webinar will be useful to all individuals involved in developing and filing novel drug products. In particular, those involved in manufacturing, packaging and release testing of drug products. In addition it will be insightful to excipient suppliers.

  • Quality Control Personnel & Management (particularly microbiologists)
  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  • Excipient suppliers

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. David  Elder - ICH Quality Guidelines Expert

Dr. Dave Elder studied chemistry at Newcastle upon Tyne (BSc, MSc), before moving to Edinburgh to study for a PhD in Crystallography. He is a visiting professor (King’s College, London). He has 38-years of experience at a variety of different pharmaceutical companies (Sterling, Syntex and GSK). Dr. Elder was a director within the product development group in GSK R&D, but is now an independent consultant.

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