Technology Forum: The Next Steps for Pharma Manufacturing Efficiency and Effectiveness

Register Free: https://www.pharmtech.com/pt_w/steps

Event Overview:

Quality and efficiency are long-running—and sometimes conflicting—themes for the manufacture of aseptically processed pharmaceuticals and oral solid dose drugs. The global COVID-19 pandemic brought many existing pharmaceutical manufacturing shortcomings to the forefront. Shortages in materials, capacity, drugs, and limited regulatory oversight highlighted the need for better technologies, processes, and procedures. In this Technology Forum, experts from different segments of the industry assess current challenges and propose solutions to recurring and emerging challenges in aseptic and oral solid-dose drug production.

Who Should Attend:

• Process development staff
• Manufacturing and operations experts
• Process engineers
• Facility managers
• Quality control team members
• Pharmaceutical professionals developing drugs for multiple regions
• Pharmaceutical professionals developing oral solid dose drugs
• Bio/pharmaceutical professionals developing aseptically processed drugs

Technology Forum Schedule:

10am EDT

Regulatory Expectations, Guideline Revisions, and Best Practices in Aseptic Processing

Moderator: Felicity Thomas, European Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International

Despite advancements, aseptic processing remains a challenge for the bio/pharma industry. Regulatory scrutiny of aseptic processes is intense, and associated guidance documents demand strategies that are driven by a quality risk management approach. Both regulatory expectations and recent regulatory revisions are impacting manufacturing operations. Technological advancements designed to improve processes and emerging best practices can help facilities worldwide overcome the pitfalls that plague aseptic processing operations and ensure the cost-effective manufacturing of quality drug products.

Consultants, academic experts, and representatives from industry associations will share recent developments in the following key areas:

• Global regulatory expectations
• Annex 1 revisions
• Pre-use post sterilization integrity testing (PUPSIT)
• Automation and minimizing human interaction with sterile drug products
• Evaluating validation practices for advanced manufacturing operations

11:15am EDT

Industry Demos and Presentations

1pm EDT

Advanced Solid-Dosage Drug Manufacturing with Continuous Processing Approaches

Moderator: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International

Advanced manufacturing strategies, such as continuous manufacturing, have the potential to reduce operating cost and improve quality for oral solid-dosage drugs. Approaches range from individual unit operations running continuously to end-to-end processes. Early adopters have addressed some challenges, and strategies are being adopted for generic drug manufacturing and for reshoring of domestic drug production. Further technology advances, as well as workforce development and consideration of standards and regulatory issues, are underway.

Consultants, academic experts, and representatives from industry associations will share insights on the following topics:

• Industry use and development of continuous OSD manufacturing processes
• Modeling and process control strategies
• Standards and regulations
• Workforce development and training
• Near- and long-term outlook for continuous manufacturing

Register Free: https://www.pharmtech.com/pt_w/steps