A QbD Approach to Annex 1 and Parenteral Packaging Manufacturing and Supply

Pharmaceutical regulations are evolving, and with that evolution comes a need for parental packaging manufacturers to meet increasing demands. This webinar will provide insights on the latest trends and challenges in the pharmaceutical industry, including how these challenges can be addressed by having a quality by design (QbD) approach to the manufacturing of parenteral packaging components, specifically regarding Annex 1.

Register Free: https://www.pharmtech.com/pt/qbd-approach

Event Overview:

Pharmaceutical regulations are evolving, and with that evolution comes a need for parental packaging manufacturers to meet increasing demands. This webinar will provide insights on the latest trends and challenges in the pharmaceutical industry, including how these challenges can be addressed by having a quality by design (QbD) approach for the manufacturing of parenteral packaging components. The elastomeric manufacturing process will be introduced, and the audience will gain an understanding of how packaging suppliers are using a QbD approach to meet Annex 1 expectations.

Key Learning Objectives

• Understand challenges and common concerns in the pharmaceutical industry.
• Define sources of contamination in pharmaceutical elastomer manufacturing.
• Discuss how a focus on manufacturing and a QbD approach can help to overcome these concerns.
• Describe the elastomeric manufacturing process using a QbD approach to meet Annex 1 expectations.

Who Should Attend

• Quality/regulatory personnel in parenteral drug delivery
• Formulation scientists and packaging engineers
• Device development engineers and managers
• Technical functions surrounding drug delivery systems
• Extractable and leachable experts
• Procurement professionals

Speaker

Ashwini Bhisikar
Technical Key Account Manager
Datwyler

Ashwini is a technical expert with over 11 years of experience in primary packaging components. She joined Datwyler in 2018 as a technical key account manager for South India, Southeast Asia, Japan, and Korea.

In her current role, she brings subject matter expertise for elastomeric components and provides consultation for suitable packaging components used in parenteral drugs starting from product inception to market launch and product life cycle. She delivers technical support to pharma clients, leads the in-house customer-oriented technical projects, and represents Datwyler at various conferences to deliver technical presentations.

She earned her bachelor’s degree in biotechnology, MBA in biotechnology management, and graduate diploma in packaging technology from the Indian Institute of Packaging. Ashwini is currently based in Bangalore, India with her family. She is a passionate runner and likes to explore places on foot.

Register Free: https://www.pharmtech.com/pt/qbd-approach