PDA Southeast Webinar: The Reality of Virtual Drug Development, Virtual FATs, and The Modern Microbiologist’s No-Nonsense Guide to Quality Control

Let’s face it, CMC is always on critical path and while outsourcing is dynamic and fun, the reality is outsourcing can also be frustrating, especially when you discover your vendor isn’t quite what you expected or the project manager they assigned is inadequate. Virtual drug development is different from in-house development and requires a different skill set. This talk will focus from the Sponsor point of view on CMC and Quality outsourcing, with personal stories about what worked and what didn’t. Drug development is the perseverance of problem solving and even more so in an outsourced business model. Sponsor plans need to be streamlined with flexibility, coordinating multiple vendors/CDMOs into an integrated timeline with many items outside the Sponsor’s control. You have to operate not only inside the Sponsor Quality Management System (QMS), yet also according to the vendor’s QMS. Questions can include - what are the core Sponsor source documents and what is needed to guide the vendors activities appropriately? We will review some Sponsor best practices to ensure a project’s success while operating in a virtual environment: Topics include:

• Vendor Selection – How not to fall for the CDMO bait and switch
• Audits – Do’s and Don’ts of Virtual/Hybrid Audits
• QMS – What type of QMS is needed for a 100% Virtual Company
• What does phase appropriate really mean to the Sponsor – what assays are the toughest
• Quality Agreements - Language Sponsor Needs
• Defining Core Sponsor Source Documents
• How, what, and when to communicate with a CDMO
• Tips on successful Project Kick-Offs and Routine Meetings
• How to Course Correct a Virtual project

Jessica Blomberg, Ph.D. owns Quality CMC Consulting (QCC), an award-winning pharmaceutical development consulting company, providing laser analytical focus in a compliant manner. She has worked with countless vendors globally for the past 18 years across all stages of development in various product types: oral, parenteral, topical, inhalation. In addition, she has established QMS for virtual Sponsors and improved vendor/CMOs QMS to be phase appropriate, flexible, and customer focused.

This topic came to fruition out of the necessity to address the risks that the Covid-19 pandemic posed to air travel and industry professionals working closely with their vendor partners so that vitally important Factory Acceptance Tests could continue to add value and reduce the time to market for life-saving therapies including parenteral vaccines.

We will explore the technology used with a presentation that includes photos, videos, and an analysis of the risks, benefits, and challenges of performing virtual FATs.

David A Yaffe, CPIP, PMP, is a Project Manager at Commissioning Agents, Inc. with over 41 years of professional experience. His responsibilities include staff training and development, marketing/sales support, and serves as a mentor for the company. He executes many projects in a range of areas including change control development and execution, maintenance and reliability engineering, quality risk management, C&Q program implementation, and risk-based validation programs. Mr. Yaffe is currently serving as an at-large member of the PDA SE Board of Directors and has attended many local PDA events over the years. He served on the Carolina South Atlantic Chapter of the ISPE as the Programs Committee Chair and on the Board of Directors for two years. Mr. Yaffe is a retired naval nuclear submarine Chief Petty Officer who served for 20 years. Mr. Yaffe earned a B.S. degree in Human Resources Management from the New School for Social Research, NY, NY, is a Certified Pharmaceutical Industry Professional, and a Project Management Professional.

Better, faster, cheaper. That’s what today’s laboratories are being tasked with. Yet resources are shrinking while regulatory demands are mounting. You run a tight ship, but still find it challenging to keep up. If this sounds at all like what you’re facing, you won’t want to miss this webinar. We’ll discuss the essentials of Growth Promotion Testing, Environmental Monitoring, Burkholderia cepacia complex (BCC) and USP <60> and we’ll explore ways you can optimize your microbiological quality control program for ultimate efficiency.

Kali Sorum, RM has been a part of the Technical Support Team at Microbiologics since 2012. During her time in the role, she has provided technical support to Microbiologics’ customers internationally and domestically for our products used as Quality Control reference materials in various industries such as the Pharmaceutical, Food, Cosmetic and Clinical. She addresses how they are used and implemented in Quality Control testing for multiple regulations including but not limited to the USP, BAM, CLSI, FDA, and others. Other duties include investigation of product complaints, planning and executing laboratory investigations, assisting and developing training programs on the use of our products and specific test methods, as well as supervision of the Technical Support Team. Kali has also been a part of the Internal Audit Team since 2014. Auditing yearly to FDA Part 820, ISO 17025, ISO 13485 and ISO Guide 34 standards. She has a Bachelor of Science degree from Nebraska Wesleyan University in Biology and Pre-Pharmacy as well as a minor in Chemistry. She has been certified as a Registered Microbiologist in Pharmaceutical and Medical Device Microbiology (RM) through the National Registry of Certified Microbiologists (NCRCM) since June of 2016.