A Systematic Approach to Extractables and Leachables: A Review of Guidance from the Industry

Life Sciences, Medical Device, Medical Device Safety and Regulation, Pharma Manufacturing and Supply Chain,
  • Tuesday, April 03, 2018

Learn from extractables and leachables subject-matter expert, Aryo Nikopour, who will review best practices (including case studies) and provide a thorough systematic approach to extractables and leachables in accordance with PQRI (Product Quality Research Institute), BPOG (BioPhorum Operations Group) and/or USP General Chapters <1663> and <1664> for the various phases of extractables and leachables including:

  • Controlled extraction studies
  • Model extraction studies
  • Leachables method development and validation studies
  • Leachables studies in support of stability

This webinar is an excellent opportunity for individuals involved in analytical development, formulation development, and/or manufacturing to expand their knowledge and develop an optimal approach for extractables and leachables in support of single-use systems and containers/closures including, but not limited to:

  • Injectable products
  • IV bags
  • Medical devices
  • Ophthalmic
  • LDPE ampoules
  • PVC blister packs
  • Inhalation products
  • Nasal products

Register for this webinar today and help eliminate possible risks of introducing foreign materials to your drug development process and expedite time to market. 

Speaker

Aryo Nikopour, Senior Vice President, Scientific and Technical Services, Nitto Avecia Pharma Services

Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, has been with Nitto Avecia Pharma Services (formerly known as Irvine Pharmaceutical Services) since early 2004. Mr. Nikopour has nearly 30 years of experience in the pharmaceutical industry with expertise in the areas of chromatographic method development and validation, quality control, stability testing and associated cGMP regulatory requirements. Aryo brings significant pharmaceutical industry experience in product development of small and large molecules, including proteins, peptides and drug delivery platforms.

Prior to joining Avecia Pharma, Aryo served as the Director of Research and Development, at Pharmaceutical Product Development, LLC (PPD) where he was responsible for pharmaceutical development and stability programs that involved multiple development and manufacturing sites. Prior to PPD, Aryo worked at Solvay Pharmaceuticals and AlPharma Inc. Mr. Nikopour holds a Bachelor of Science degree in Chemistry from the University of Southern Minnesota.

Message Presenter

Who Should Attend?

Professionals from the pharmaceutical, biopharmaceutical and medical device industries involved with development, manufacturing, testing, and quality control of regulated products.

  • Pharmaceutical and Biopharmaceutical Industries
  • Decision makers for outsourcing analytical services/manufacturing
  • Small to large pharma/biopharma

Example titles include:

  • Vice President/Senior Director/Director, Manufacturing
  • Vice President/Senior Director/Director, R&D
  • Vice President/Senior Director/Director, Analytical Development
  • Vice President/Senior Director/Director, Analytical Chemistry
  • Vice President/Senior Director/Director, CMC (Chemistry Manufacturing Controls)

What You Will Learn

Get best practices, insights and sample case studies for extractables and leachables studies in accordance with industry guidelines.

Xtalks Partner

Nitto Avecia Pharma Services

Nitto Avecia Pharma Services is your single solution for premier contract development and manufacturing services. Nitto Avecia Pharma Services supports the pharmaceutical, biopharmaceutical, and medical device industries with a complete package of CGMP services (small to large molecules) including:

  • Formulation/process development
  • Parenteral manufacturing (liquid/lyo)
  • Analytical development
  • Analytical chemistry
  • Stability
  • Structural chemistry
  • Microbiology
  • drug delivery device testing

With three state-of-the-art facilities located on one campus in Irvine, California, Nitto Avecia Pharma Services’ experienced staff and robust quality infrastructure delivers client-centric solutions for early phase through post-market life cycle management. We invite you to visit us, audit our facilities, discover our insight, and learn more about our commitment to excellence. Learn more at www.aveciapharma.com or call (949) 951-4425.

Media Partner

Pharmacompass

PharmaCompass is the one-stop, pharmaceutical information platform developed for professionals to make your strategic business decisions. It’s your free-access, integrated global database with detailed regulatory information on products and companies. The PharmaCompass’ team directly connects buyers to the right contacts at the suppliers without getting involved in commercial transactions.

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