Maintaining GMPs During a Global Emergency

Industry news | 23 April, 2020 | CACLP

The novel coronavirus pandemic has presented the global pharma industry with a double challenge: to develop potential treatments and preventative vaccines, and continue to meet the existing needs of healthcare providers and patients, all at a time when travel bans are in place and work must be handled remotely or with special precautions.

In the initial weeks of the present emergency, bio/pharma companies, contract service providers, and regulatory authorities have taken measures to ensure continued operations. While addressing the challenges of today, the bio/pharma industry also needs to look ahead to what may be new operating and supply chain conditions for the coming months or years.

During a special online presentation—broadcast on April 28, 2020 at 11 am EDT—the editors of Pharmaceutical Technology and BioPharm International interview experts who will discuss approaches that are helping manufacturers surmount these challenges, while technology providers and representatives from different facets of the pharma industry—regulatory, contract testing and manufacturing, quality control, and distribution—will share best practices that are enabling them to meet the pandemic’s challenges head on.

Topics to be discussed in this Editors’ Series event, Ensuring the Continuous Supply of Quality Drug Products During Uncertain Times, include the following:

Business continuity best practices

Employee and facility safety

Regulatory compliance

Addressing deviations

Testing guidance for new and existing drugs

Supplier oversight

Supply chain challenges

Data security, data integrity, and remote data access and collaboration.

Invited speakers:

Steve Goldman, consultant, Steve Goldman Associates

David Light, CEO, Valisure

Susan Schniepp, distinguished fellow, Regulatory Compliance Associates