Meranda Parascandola

April 28, 2021

DSI Announces Its Acquisition by ProductLife Group

(Harleysville, PA; April. 28, 2021) – We could not be more pleased to become part of a global leader in the life sciences regulatory and compliance industry. Joining PLG is exciting both for DSI as a business and for our clients, who will now have access to additional specialist expertise […]
March 12, 2021

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

Michael Carroll is Senior Consultant of Microbiology and Aseptic Manufacturing at Design Space InPharmatics. He is an accredited Microbiologist with over 35 years of product development, quality control, and GMP manufacturing experience in the pharmaceutical, biotechnology, and medical device industries. In this episode, Ed, Meranda, Brian, and Mike discuss the Parenteral Drug Association, the role of regulatory approvals, and other stories from Mike’s illustrious career. They talk about the ever-evolving nature of CMC and the pressures of working in drug development and manufacturing.
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.