Technology Transfer for API

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Training

Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course

Description

With consolidation in the industry and the advent of multinational pharmaceutical companies, the transfer of expertise and technology for active pharmaceutical ingredients (APIs) between manufacturing sites has become a commonplace occurrence. It is important to have a standardized methodology - to accommodate an increased movement and to complete the transfers in a timely and approvable manner. The ISPE Good Practice Guide: Technology Transfer describes this type of standard methodology.

Taking principles from ISPE Good Practice Guide: Technology Transfer and using the Guide as a textbook, the course will cover technology transfer of APIs and fundamentals of analytical methodology to assist in the challenges faced during API transfer. Participants will take part in exercises to demonstrate the principles presented and have additional opportunities to discuss their specific situations.

Participants will receive a complimentary copy of the ISPE Good Practice Guide: Technology Transfer.

Course Modules

• Synthesis Route and Form
• Hovione
• BioProcess Facilities
• Analytical Methods
• Health, Safety, Environment
• Leveraging Knowledge
• Microbiological Testing
• Process Information
• Case Study cGMP Compliance
• Facility Requirements
• Commissioning and Qualification
• Aventis

Take Back Your Job

• Define key terms for the technology transfer process
• Interpret regulations that govern technology transfer
• Explain the fundamentals of analytical methodology
• Describe the information required to support a regulatory product filing and the resultant product manufacturing process
• Define key roles and responsibilities of technology transfer team members
• Identify communication channels and methods to effect information transfer

Attendance Suggested For

• Professionals with technology transfer responsibilities, including regulatory compliance associates, process development scientists, facilities engineers, validation scientists, quality assurance specialists, and manufacturing managers
• Individuals new to the industry as well as seasoned professionals who need an understanding of technology transfer and want to standardize a method for implementation
• Validation and technology consultants who work in the pharmaceutical industry

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency element Product Development: Technology Transfer. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.