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Hear the expert panel review quality and regulatory challenges amid the pandemic, remote monitoring, risk-based quality management, Annex 1 changes, and lessons learned.
Listen to A “New Normal” for Quality Practices on demand.
Technology’s Role in QA/QC
Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.
2020 Bio/Pharma Virtual Congress
The COVID-19 pandemic has posed serious challenges in pharmaceutical supply chain management and quality assurance and control (QA/QC) at a time when budgets and staffing at many companies have been constrained. Identifying the cultural roots of quality problems challenges pharma’s quality leaders to establish a culture of quality. A growing trend is the use of technology to optimize QA/QC.
A panel discussion—A “New Normal” for Quality Practices—will review quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes in the European Union, and lessons learned going forward. The panel, part of the Bio/Pharma Industry Challenges track and organized and moderated by the editors of Pharmaceutical Technology and BioPharm International, is scheduled for Nov. 11, 2020, 1:30 pm EST during the 2020 Bio/Pharma Virtual Congress.
The online Bio/Pharma Virtual Congress features a full day of panel discussions organized and moderated by the editors of Pharmaceutical Technology and BioPharm International magazines, sponsored technical sessions, a Virtual Exhibit Hall where visitors can chat in real-time with exhibitors, technical posters, and networking opportunities. Download the agenda (PDF).
The quality practices panel discussion will feature commentary from Scott Deckebach, MBA, director of compliance, Lachman Consultant Services, Inc.; Marty Lipa, pharmaceutical regulatory science team member and doctoral student at Technological University Dublin, and executive director of knowledge management at Merck and Co., Inc.; and Siegfried Schmitt PhD, vice-president, Parexel, and Pharmaceutical Technology editorial advisor and columnist.
The panel is part of the Bio/Pharma Industry Challenges track at the Virtual Congress; other topics include cleanroom qualification according to Annex 1 and Annex 15, digital signatures in the pharmaceutical value chain, and container closure integrity testing.
Registration for the day-long event (8:30 am–4 pm EST) is free to professionals involved in the development and manufacture of bio/pharmaceuticals.
Insight on the pandemic, Bio/Pharma’s response, and more
The COVID-19 pandemic’s impact on bio/pharmaceutical development and manufacturing, availability of crucial supplies, maintaining GMP compliance, and remote monitoring of manufacturing processes are other topics that will be discussed by industry experts during the 2020 Bio/Pharma Virtual Congress.
During a keynote panel discussion on Nov 11, 2020, 9 am EST, Bio/Pharma Industry—Beyond Politics and the Pandemic, representatives from industry organizations will discuss bio/pharma’s response to the pandemic and the corresponding scrutiny and political pressure, as well as the short-, medium-, and long-term implications for bio/pharma development and manufacturing.
Dosage Form Trends
How have biopharma companies responded and adjusted to pandemic issues? What lessons learned under fire may lead to more effective and efficient bioprocessing practices going forward? Eric Langer, managing partner, BioPlan Associates, Inc, shares research and expert insight in Delivering on the Promise: Overcoming Biopharma Development and Manufacturing Challenges, Drug Dosage Form track, Nov. 11, 2020, 10 am EST.
Manufacturing Trends
New technologies, such as artificial intelligence and machine learning, are being employed by bio/pharma manufacturers to collect and analyze large amounts of process data in real-time. An expert panel will discuss how this technology can be employed to optimize bio/pharma manufacturing and predictive maintenance during the Editors’ Series session, Technology Advances in Process Operations on Nov. 11, 2020, 11:30 am EST.
Formulation Trends
An expert panel will discuss the characterization of excipient components, understanding regulatory and compendial implications of excipient composition, the global supply chain, effective quality programs and prospects for preapproval of novel excipients. The Editors’ Series session, Excipients Update: Formulation, Supply and Quality, is scheduled for Nov. 11, 2020, 1:30 pm EST.
To learn more about the 2020 Bio/Pharma Virtual Congress, download the agenda (PDF).
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