Meranda Parascandola

March 12, 2021

The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll

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.
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.
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.
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 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.
January 29, 2021

Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

Ed Narke is the co-founder, Principal and Managing Regulatory Director at Design Space InPharmatics. In this episode, Meranda and Brian are turning the tables on Ed and turning him from interviewer to interviewee. Ed touches on his hometown roots, his extensive background in CMC and drug development and lessons learned throughout his career. He expounds on his current role at DSI and the impact his team has had on the industry. Ed lists some of the many mentors-turned-friends he’s had the pleasure of meeting throughout this journey and thanks them for the life lessons they taught him. Finally, Ed talks about the importance of developing powerful, positive routines in order to navigate this virtual new normal in the remote world. Those who embrace change are more likely to experience accelerated growth and wind up ahead of the pack.