This webinar provides a high-level introduction to Primary Packaging Qualification in the pharmaceutical industry. We'll take a systematic approach to qualifying packaging systems by examining four key factors: Compatibility, Safety, Protection, and Quality Control.

The session will also highlight relevant industry standards, including USP <381>, <382>, <661.1>, and <661.2>, and address common challenges encountered during the qualification process.

Whether you're new to the topic or seeking a refresher, this webinar offers valuable guidance and practical insights.

What you’ll learn by attending:

• • Different requirements of Primary Packaging Qualification
• • Available standards and regulations
• • Compatibility and control testing 

As drug developers seek out novel solutions for geriatric and pediatric populations and patients with difficulty swallowing (dysphagia), liquid suspensions have become increasingly popular. However, while liquid suspensions have distinct advantages to pills, tablets, and traditional liquid solutions for specific patient populations, their unique formulation requirements make them highly challenging to develop and manufacture.

In order to meet rising demand, CDMO partners must have the necessary expertise to accelerate liquid suspension formulation development. In this exclusive thought leadership piece, Mikart’s very own Gus LaBella, Director of Formulation Development, shares the keys to liquid suspension formulation, including:

• • Understanding the unique characteristics of liquid suspensions 
• • Leveraging novel ion exchange technology 
• • Having experience with difficult-to-formulate liquid solutions 
• • Maintaining dedicated development, manufacturing, and production facilities

The global pharmaceutical supply chain is a complex network vital for patient health, and its components are undergoing a period of significant transformation. In this webinar, Marken’s regulatory experts will share a comprehensive overview of the current state of these intricate systems, examining the confluence of evolving regulatory landscapes and the disruptive impact of recent US policy shifts. Speakers will delve into the intricacies of international sourcing, manufacturing, and distribution, highlighting the vulnerabilities and emerging opportunities that define today’s supply chain environment. 

A key focus will be on the profound influence on recent changes in U.S. policy, particularly the implementation of tariffs and their effects, such as the push for onshoring or nearshoring of pharmaceutical production. We will analyze how these measures are reshaping global trade flows, impacting drug costs, and potentially altering the structure of international logistics networks. The discussion will also address the ongoing challenges of maintaining stringent regulatory compliance across diverse jurisdictions - examining the implications of these policy changes for Good Manufacturing Practices, quality control, and the overall integrity of the pharmaceutical supply chain in a dynamic global environment.