Course Description:
Beyond the Hype: What Continuous Manufacturing Really Is and Isn’t. Continuous Manufacturing (CM) has been discussed in pharmaceutical manufacturing for more than three (3) decades. Regulatory frameworks exist, technology platforms have matured, and multiple products are approved and on the market. Yet adoption remains selective, fragmented, and often misunderstood.
This webinar cuts through misconceptions and marketing narratives to present a fact-based, experience-driven view of where Continuous Manufacturing truly stands today technically, operationally, and regulatorily.
Why This Webinar & Why Now?
- ICH Q13 is published — CM is no longer a regulatory experiment
- Hybrid and orchestrated manufacturing models dominate reality, not “pure flow”
- Business cases are often misrepresented, leading to stalled or failed programs
- CM is increasingly evaluated as a portfolio and lifecycle strategy, not a technology bet
This session focuses on truth over terminology and practical decision-making over vision statements.
Key Facts About Continuous Manufacturing
Continuous Manufacturing is NOT:
- A requirement for 24/7 uninterrupted flow regime
- A one-size-fits-all solution
- A replacement for batch paradigms overnight
Continuous Manufacturing IS:
- A lean manufacturing tool
- A control-centric manufacturing philosophy
- Often hybrid by design (continuous + discrete unit operations)
Common Misconceptions - Corrected:Myth: Continuous Manufacturing means everything must run continuously
Fact: Most approved systems are hybrid or semi-continuous
Myth: CM only makes sense at blockbuster scale
Fact: CM can enable small volumes, orphan drugs, and rapid scale-out
Myth: Regulators are not ready
Fact: FDA, EMA, and PMDA have clear expectations and precedents
Myth: CM is mainly about equipment
Fact: Control strategy and system integration define success
About the ApproachThis webinar is not a vendor pitch and not a technology showcase.
It is a neutral, experience-based assessment grounded in:
- Regulatory reality
- Industrial execution
- Lifecycle economics
- Lessons learned from real CM programs
Who should participate:
- Executive leadership and decision makers
- Manufacturing, process engineering, and MSAT leaders
- Quality, CMC, and regulatory professionals
- Technical o