Podcast
Queens of Quality Podcast featuring Michelleanne Bradley and Jennifer DiMarco
Tune in every 2 weeks when CEO Michelleanne Bradley and V.P. Jennifer DiMarco will be providing solutions for day-to-day issues to debunk some of the misconceptions about Quality Assurance. Subscribe to the show to stay up to date with new episodes.
Season 1
Intro. Welcome to Queens of Quality Podcast
Welcome to the Queens of Quality podcast with your hosts, Michelleanne Bradley and Jennifer DiMarco. Join us in our biweekly podcast episodes, where we will provide direction and be trust advisors for solutions for day-to-day issues. Additionally, we will add a balance of laughter and education as we discuss and debunk some of the misconceptions about quality assurance in the pharmaceutical industry.
Ep. 1 Quality and Compliance in the Pharmaceutical Industry
On our 1st episode, join us with your hosts Jennifer and Michelleanne where they share why they created the podcast, and their perspectives on the difference between compliance and quality.
Ep. 2 The Ultimate Guide to Audit and Inspection Readiness
Welcome to another amazing episode with your hosts, Jennifer and Michelleanne. In today’s episode, we talk about the importance of inspections and audits, identifying the right people to be in front of an inspector, and people’s perception of inspectors & auditors.
Ep. 3 The Regulatory
Landscape
In today’s episode, we talk about the regulatory landscape of the pharmaceutical industry. We focus on the role of regulatory organizations and the changes that have taken place in the regulatory process since the development of the polio vaccine.
Ep. 4 Adopting A Proactive Approach to Quality and Compliance
In this episode, we talk about adopting a proactive approach to quality and compliance. We talk about the most significant learnings from COVID-19, acknowledging workplace mistakes, and the importance of forgiveness in the workplace. Moreover, we share the difference between a mistake and something being wrong.
Ep. 5 Pharmacovigilance
Welcome to another incredible episode with your hosts, Jennifer and Michelleanne. In this episode, we focus on pharmacovigilance in the pharmaceutical industry. We talk about who is responsible for drug safety & pharmacovigilance, the sources of pharmacovigilance data, and pharmacovigilance in clinical trials.
Ep. 6 Risk Evaluation
and Mitigation Strategy
Join in another fantastic episode with your hosts, Jennifer and Michelleanne. In today’s episode, we talk about Risk Evaluation and Mitigation Strategy (REMS). We talk about the history of Thalidomide and why REMS closely monitors it.
Season 2
Ep. 1 Cultivating a Quality
Culture in Pharma
& Biotech
Welcome to season two of Queens of Quality. In our latest episode, we dissect this complex subject of the crucial role that culture plays in the pharmaceutical and biotech industries.
Ep. 2 A Comprehensive Guide to Audits and Compliance in Pharmaceuticals
In podcast episode #2 this season, hosted by Jen and Michelleanne, the women dive deep into the intricacies of pharmaceutical and biotech industries, focusing on audits, vendor qualifications, and quality compliance.
Ep. 3 Leadership Support
and Inspection Readiness
“Queens of Quality,” hosts Michelleanne and Jen delve into the pivotal role of leadership support in achieving operational efficiency, inspection readiness, and organizational success. They discuss the often underestimated impact of leadership in various areas, including resources, teamwork, communication, and preparedness.
Ep. 4 From Bench to Bedside:
Navigating Failures
and Triumphs
in Pharma and Biotech
Navigating Failures and TriumphsIn this episode of the Queens of Quality podcast, we explore the importance of discussing failure alongside success in the pharmaceutical and biotech industries.
Ep. 5 The Evolution of Compliance
in Biotech and Pharma
with Cheryl McCarthy
Michelleanne and Jennifer discuss the complexities of quality and compliance with Cheryl McCarthy. They discuss the new ICHU6R3 guidance and the importance of explaining the rationale behind actions.
Ep. 6 Revolutionizing the REMS Industry with Sherice Mills
Join us in this podcast episode as we decode compliance and quality assurance complexities in the pharmaceutical and biotech industries with Sherice Mills, founder of ADROIT Risk Management.
Ep. 7 A Journey through the Pharmaceutical Regulation and Quality Design
In this episode of Queens of Quality, Michelleanne and Jennifer explore the key concepts of ICH (International Council on Harmonization), with a focus on the recent revisions to ICH E6R3 and ICH E8R1.