Maintaining GMPs During a Global Emergency
Experts to discuss strategies for ensuring supply of quality drug products during a pandemic in April 28 online event.
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
- Jaap Venema, executive vice president and chief science officer, United States Pharmacopeia
- Mary Blenn, vice-president global supply chain, Cytiva
- Angelo Stracquatanio, CEO, apprentice.io
- Lisia Marina Scholz Dias, lead application engineer, Applied Materials
The webcast is organized by Pharmaceutical Technology and BioPharm International magazines, in conjunction with the INTERPHEX trade show.
Registration for the webcast is free. Register via this link.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.