article thumbnail

Update on CDER, CBER, and CDRH Meetings with Industry

The FDA Law Blog

The pandemic had changed the way people live, work and communicate. It is also crucial to maintain a respectful and cooperative demeanor, document the meeting discussion and action items, and promptly address follow-up actions. Such changes are not limited to personal circumstances.

FDA 53
article thumbnail

ISPE Represented at PIC/S 50th Anniversary Event

ISPE

Some of the highlights of the presentations given during the Symposium were as follows: The PIC/S Chairperson, Paul Gustafson, Health Canada, presented on PIC/S’ new strategic plan for 2023-2027 which covered the following elements: Promote, improve and monitor inspection reliance amongst PIC/S member authorities.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Considerations for a Decentralized Manufacturing Paradigm

ISPE

Nature Communications 12, no. Fill Finish Manufacturing Market by Product (Consumables (Prefilled Syringes (Glass, Plastic), Vial (Glass), Cartridge), Instrument (System (Stand alone, Integrated), Machine Type (Automated, Manual))), End User (CMO, Biopharma) & Region - Global Forecast to 2027.” Biotechnology Progress 36, no.

article thumbnail

Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. A Strategy for the Sector 2023–2027.” You may unsubscribe from these ISPE communications at any time.