The purpose of this webinar is to provide an overview
of the best practices in the selection and qualification of
materials that will come in contact with drug products during
the manufacturing process with flexible containment. The
webinar will highlight the requirements development process, the
regulatory requirements to be addressed and the method of
meeting these needs to assure success in providing the
acceptable film for specific pharmaceutical manufacturing
processes. We will cover the needs for bulk active
pharmaceutical ingredients (APIs) as well as final processing
leading to the finished products for Oral Solid Dosage
forms. The goal of this webinar is to provide an
understanding of this key part of the flexible containment
solution, provide some insight into the tools to help with the
system selection process, and provide input to support the NDA
filing process.
In this webinar you wil
learn:• Basic plastics
101
• Processing application areas to
consider
• The regulatory organizations
of interest
• The regulatory documents
of interest
• An overview of films and
REACH (REGISTRATION, EVALUATION AND AUTHORISATION OF CHEMICALS,
REGULATION (EC) 1907/2006 OF THE EUROPEAN
PARLIAMENT)
• Definitions of key
requirement, threshold requirement and objective
requirement
• The typical
requirements:
• Regulatory,
safety
• Material
physical
• Application
physical
•
Supply
• Supplier
requirements
I
nstructor:
Alan George
