Extractables & Leachables - Training / Workshop von PDA Europe gGmbH

When making Parenteral Drug Products, pharmaceutical companies are faced with the need to further investigate the materials that will be in contact with the drug product, either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, also quality issues – i.e. for biophar-maceuticals – have become an additional concern. This workshop will look at "Extractables & Leachables" from many different angles: Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, Study Design for different parenteral primary packaging systems, as well as for injection devices.

Upon completion of this workshop, you will be able to:

• Explain in detail the current regulatory requirements for container/closure qualification from an E/L perspective.

• Explain the upcoming changes in regulations, standards and recommendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.

• Understand the materials of construction – and their composition – of container closure systems, and how they could impact the safety and quality of a parenteral drug product.

• Put together an evaluation program (review of provided documentation, analytical testing) of different types of parenteral drug product container/closure systems.

• Perform a safety/risk assessment of analytical results, obtained after completion of an E/L study

• Pharmaceutical Packaging and Device Engineers
• Production Engineers, using SU systems
• Regulatory Affairs Officers
• Pharmaceutical R & D Managers
• Analytical Chemists, working on E/L
• Quality Assurance Officers