FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance. In this podcast learn what QMM is, and how far beyond GMP functions QMM will drill into, and what accountability senior management bears for sustaining a corporate quality management culture, from an interview with executives at Shabas Solutions LLC, who ran the overseas pilot program.

FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to David Tisi, technical director at Senopsys LLC, and Reenal Gandhi, global business development director for the Prescription Division of Aptar Pharma. In the first segment of the episode, David chats about some of the key challenges impacting oral dosage forms and the approaches and solutions available that are helping developers overcome these hurdles. After, Reenal details the intricacies of intranasal drug dosage forms, such as the convenience and the growth of this route of administration, challenges of development, and the possibilities of repositioning drug products. 

SPONSOR:  Lonza

Innovations and Advances in Drug Dosage Forms

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics.

mRNA Past, Present, and Future

Dr. Graziella Piras, senior director of Strategic Marketing at 908 Devices, discusses drug development, specifically about monitoring bioprocess parameters and other important technologies important to moving the process forward, with Pharmaceutical Technology editor Jill Murphy.

Breaking Through the Barriers of Drug Development

In this episode of the Drug Solutions Podcast, Shawn Liu, the president and CEO of Avirmax, relates his experience in entering the cell and gene therapy manufacturing space and how he began his own startup cell and gene therapy CDMO.

SPONSOR: Lonza

Starting Up in the CGT Manufacturing Space

The trend toward digital transformation in biopharmaceutical manufacturing continues as advanced technologies enter the scene and work their way through to manufacturing operations. With the availability of technologies to take automated biomanufacturing from preclinical to commercial-scale, the industry may start to see a wave of changeovers from manual processes to an automated, digital environment. This episode of the Drug Solutions Podcast will discuss the realities of switching over from manual to digital, and what to expect.

Digital Transformation in the Biopharma Industry

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.

Gliding Through the Ins and Outs of the Pharma Supply Chain

In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Tom Fletcher, director of Research and Development at FUJIFILM Irvine Scientific; and Bob Newman, PhD, chief scientific director at FUJIFILM Irvine Scientific, about formulation, specifically with how to prepare culture media for use, single use technologies, and automations to create closed systems in cell/gene therapies.

Staying on Track with Formulation of Cell Culture Media

In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

The Biosimilars Landscape

Applying Appropriate Analytics to Drug Development

In this episode of the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

A Closer Look at mRNA in Oncology and Vaccines

The Drug Solutions Podcast, presented by Pharmaceutical Technology, features industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join the editors as the experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.
To learn more, visit https://www.pharmtech.com

FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

Drug Solutions Podcast

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