Best Practices for Meeting and Exceeding Regulatory Standards in Primary Packaging USP and

Register free: http://www.pharmtech.com/pt_w/design_principles

Event Overview:

In today’s regulatory environment, stricter requirements are being placed on primary packaging components for parenteral drug products. Packaging suppliers are making efforts to meet these requirements in order to ensure their products are accepted by both regulatory bodies and pharmaceutical companies. This webcast will analyze United States Pharmacopeia (USP) General Chapters <381> and <382> and discuss ways to not only meet the regulatory requirements currently in place, but to exceed them with an effort to create a future-proof regulatory pathway.

Topics will include:

• A review of USP General Chapter <381>, “Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems”

• An introduction to USP General Chapter<382>, “Elastomeric Component Functional Suitability in Parenteral Packaging/Delivery Systems”

• A discussion of the best practices for meeting current industry requirements currently for elastomeric primary packaging

• Using industry trends, a look to the future of regulatory requirements for elastomeric components, as well as the presentation of a future-proof strategy to ensure standards are met over time

Key Learning Objectives:

Understand the risks that face the pharmaceutical industry today regarding stricter and evolving regulatory requirements

Introduce the requirements and understand the implications of USP <381> and <382> for elastomeric components

Review future trends and how to prepare for regulatory changes over time

Speaker: Renaud Janssen, Vice President Technical Services, Datwyler

Time and date: Part II: Wednesday, Jul. 22, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm CEST

On demand available after airing until Jul.22, 2021

Sponsor: Datwyler

Register free: http://www.pharmtech.com/pt_w/design_principles