Drug Solutions Podcast: Drug Manufacturing Technology

Jennifer Markarian,

In this episode of the Drug Solutions Podcast, Jennifer Markarian, manufacturing reporter, talks about the continuous manufacturing of oral solid-dosage drugs with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company.

Tips For Successful Remote FAT

Moria Feighery-Ross, CQA, CMQ/OE Sr. Validation Engineer

Strong Leadership

Coordinates between key stakeholders
Drives on-time schedule completion
Expects the unexpected

Coordinate Communications

Ensure platforms are compatible
Strategize formal and informal communication during the process

Technology

Choose an intuitive video conferencing platform w

What is the difference between approval, authorization, and clearance?

Michael Cooper, RAC, Clinical and Regulatory Affairs Program Manager

These common terms are often used incorrectly.

SARS-CoV-2 Variants

Bikash Chatterjee, CHIEF EXECUTIVE OFFICER

What is the impact of the Delta Variant?

Key Considerations for Scale Up Cell & Gene Therapy

Barrett Fallentine, Director, Product & Process Development

A comparison of two types of cell sources. Key considerations for scale up for cell and gene therapy.

Forced Degradation

Brian Glass, Senior Analytical Consultant

Regulations mandate that methods for analysis of drug substance and drug product are stability indicators.

Considerations for CDMO Selection

Barrett Fallentine, Director, Product & Process Development

When considering a CDMO partner keep in mind your future needs.

Navigating the FDA’s Emergency Use Authorization Process

Bikash Chatterjee, Chief Executive Officer

A graphic representation of the FDA’s Emergency Use Authorization Process.

Best Practices for Creating Submission Ready Documents

Barrett Fallentine, Director, Product and Process Development

Instituting good documentation policies early on when developing your biologic drug product can save time and distress when putting together your regulatory submissions.