FDA

February 11, 2021
Year of the Ox

Will the Year of the Ox Bring You Luck?

What daring goals did you set in 2020?  Did you reach them? 2021 is a New Year. Your year to get clear on where you're going and how to get there.
February 12, 2021

Regulatory Odd Couple with Ed Narke & Meranda Parascandola

Edward Narke is a Principal and Regulatory Managing Director and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed and Meranda discuss topics they’ve covered on DSI’s ongoing blog series, The Regulatory Odd Couple. They dive deep into the process of regulatory drug development, including the importance of having regulatory starting materials, building the quality overall summary and the role that excipients play in that process. Ed and Meranda share their thoughts on the analytical framework of API and other stages of pharmaceutical development.
February 19, 2021

Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly

Shelli Connelly is a Senior Drug Product Consultant at Design Space InPharmatics. With over 20 years of long- term success in the pharmaceutical manufacturing industry, Shelli has expertise in pharmaceutical process validation, business development activities, strategic planning, and more. In this episode, Shelli shares her thoughts on filter validation, including what to do if you pick the wrong filter, how filter vendors represent the best resources and the importance of having a partner with experience in filter validation.
February 26, 2021

A Broadway Performance Analogy for API Process Validations with Jim Mencel

Jim Mencel is Senior Drug Substance Consultant at Design Space InPharmatics. With an extensive background in CMC management, Jim has a wealth of knowledge on the topic of process validation. Process validation is an integrated and mandatory process in the pharmaceutical industry to ensure all processes are in compliance with regulatory standards. In this episode, Jim provides his thoughts on the significance and science of process validation in the pharmaceutical industry as it pertains to drug substances. He discusses the evolution of batch documentation, expounds on PAR and CPP and stresses the importance of communication.
March 4, 2021
Introduction to Chemistry, Manufacturing, and Controls (CMC) Regulatory Strategy

Introduction to Chemistry, Manufacturing, and Controls (CMC) Regulatory Strategy

With comprehensive, integrated CMC Regulatory Strategy, emerging sponsors gain greater insight into their Drug Development programs, avoiding bottlenecks and mitigating risks before they lead to mistakes and costly delays. Boost your compliance performance across the complete lifecycle. Ensure consistency and quality in every transaction.
March 5, 2021

Quality Management Systems Explained!

Bettina Kaplan is the Head of Quality Assurance Services, Robbi Freisem and Susan Fasso are Senior Quality Assurance Consultants and Maria Arakil is a Quality Assurance at Design Space InPharmatics. Together, this talented panel of subject matter experts join Ed, Meranda and Brian to discuss all things Quality Management Systems. QMS are highly complex and many organizations struggle to implement them. They discuss a brief history of QMS, the timing required and guiding documents, such as the Code of Federal Regulations. They talk about reasons why quality agreements are necessary and the value in hiring an experience quality professional.