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Agenda
Agenda
Overview
• Identifying when and which packaging components require an extractables and/or leachables study
• Present current best practices for injectable and ophthalmic products
• Designing an E&L study that is appropriate for specific types of packaging materials/components and drug product types
• Understanding the time & costs for an E&L study; and how to choose a qualified laboratory and toxicologist
• Reviewing the E&L workflow of identifying, quantifying, and assessing E&L to determine if packaging is qualified for the specific drug product application.
• Reviewing the current regulations, guidance documents, and literature that impact the definition of " current best practices"
Who Should Attend
Packaging Engineers; Formulators of Drug Products; Quality Assurance & Control Professionals; Chemical Analysts; Regulatory Professionals; Scientists responsible for Stability Studies and/or Extractables & Leachables Studies; Toxicologist.
Industry: Pharmaceutical, Biotechnology, Medical Device
Learning Objective
• Understand the regulations and current regulatory expectations of a submission that includes and E&L study
• Be able to identify the packaging components and materials that require an E&L study
• Be familiar with the workflow, time, and cost of an E&L study
• Know how to choose a 3rd party laboratory to perform extractables & leachables testing
• Understand current best practices of E&L management...including new information on injectable products.
Program schedule
All courses begin at 8:00 a.m. and end at 5:00 p.m. unless otherwise noted in course information posted on the website or in the course brochures.
Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. You will not be able to attend a course without payment, or guarantee of payment.
A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:30 - 1:30 p.m. Snacks will be provided during the morning break from 10:00 - 10:30 a.m. and the afternoon break from 3:00 - 3:30 p.m.
Presenter
Edward J. Smith, Ph.D.
Packaging Science Resources
Principal
About Presenter
Ed Smith is Principal at Packaging Science Resources which provides consulting and training in packaging for the pharmaceutical, biotechnology, and medical device industries. Services include:
Development of Extractables and Leachables Management Strategies
Total Package Development for Parenteral Drug Products
Guidance on Cold Chain Transport and Storage for Vaccines and Temperature-Sensitive Pharmaceuticals
Specification and Test Protocol Development for Packaging Materials and Components
DMF Preparation and Filing
Guidance on Compliance with FDA, USP, Ph. Eur., JP, and ISO
Training on Packaging Principles, Practices, and Regulations
Ed is a member of the PDA and American Chemical Society. Within PDA, he leads the Packaging Science Interest Group, and is on the Steering Committee of the Pharmaceutical Cold Chain Interest Group (PCCIG) where he co-authored PDA Technical Report 39 on cold chain best practices. He is also a member of the PQRI Working Group on Parenteral & Ophthalmic Drug Products (Extractables/Leachables). He is a member of the faculty of the PDA Training and Research Institute. He is also a member of the ACS Consultants Network and is a Senior Advisor at Genesis Technical Advisors, a group formed to provide comprehensive packaging project management and training.
He has published many articles and chapters on pharmaceutical packaging and is a frequent speaker at industry meetings and courses related to extractables/leachables and cold chain.
Prior to forming his consulting practice, Ed was associated with Wyeth Pharmaceuticals where he headed a team responsible for the development and qualification of cold chain packaging systems for transporting temperature-sensitive drug products. He also served as a technical expert on parenteral packaging issues particularly with respect to the management of extractables and leachables. Before that, he was associated with Helvoet Pharma Inc. and West Pharmaceutical Services in various technical management positions. He holds a B.S. in Chemistry from Villanova University and received his M.S. & Ph.D. in Analytical Chemistry from Seton Hall University (So. Orange, NJ).
Registration Fee
Up to & on December 31: $695
On & After January 1: $795
Government/Academic: 20% off above pricing. Please fill out the form and email/fax with proof of employment.
Group rate: Register 4 people and the fifth is free. Please fill out the registration form and email/fax at the same time.
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