FDA's Update on Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines - Are you ready?

Duration: 90 Minutes
New, dramatically different requirements for elemental impurities will soon be introduced for most pharmaceutical products. These requirements cover more metals and require lower limits than the antiquated Heavy Metals test. Additionally, the analytical technique, ICP-MS, is much more challenging. By attending this course you will learn about the new requirements and also about using risk assessment to minimize unnecessary testing and meet FDA expectations.
Elemental Impurities
Instructor: Gregory Martin
Product ID: 501732
Objectives of the Presentation
  • How the new FDA Guidance on Elemental Impurites is related to ICH Q3D and USP Chapters 232 and 233
  • What drug products are within the scope of the guidance
  • Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
  • How risk assessment influences what testing is required
  • What documentation related to control of elemental impurities is expected by FDA
  • Which procedures can be used to demonstrate compliance
  • How methods should be validated
Why Should you Attend
FDA has issued a Draft Guidance on Elemental Impurities in Drug Products, which addresses ICH Q3D and USP General Chapters 232 and 233 on this topic. The Guidance makes recommendations on how to submit NDAs or ANDAs for non-compendial drug products, and how manufacturers of compendial drug products can comply with the new requirements. The similarities and differences between ICH Q3D and USP 232/233 are discussed, and recommendations are made for different categories of drug products, including compendial and non-compendial, and those approved under an NDA/ANDA or not approved under an NDA/ANDA. A risk-based approach to the control of elemental impurities is advocated, which informs which elements are likely to be present and what controls are appropriate. The guidance also addresses validation of analytical procedures and early adoption of the standards.

Areas Covered
  • Elemental Impurities: The case for Change
  • Overview of Guidance Documents: FDA, ICH Q3D, USP 232/233
  • Scope of the guidances
  • Risk Assessment
  • FDA Recommendations
  • Controls and Documentation
  • Analytical Procedures and Validation
  • What you should be doing now
Who will Benefit
Pharmaceutical R&D and QC chemists and their managers; Regulatory Affairs personnel, including those responsible for filing NDAs and ANDAs or other drug products and those responsible for Annual Reports and updating analytical methods and specifications. Individuals at Contract Manufacturing and Contract Laboratory facilities should also attend.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
View More