COURSE DESCRIPTION

OVERVIEW

The pharmaceutical business has a global shortage of aseptic fill sites and flexible biological manufacturing plants. This is primarily due to the decade-long mergers/acquisitions and consolidations in industry, driven by the financial pressures. This has forced facilities to produce and perform well beyond their anticipated useful lifespan.  Existing facilities have been forced to expand production, change product portfolios, and – more than likely – undergo a change of ownership. The change of ownership has often not allowed the infusion of capital upgrades that are needed for technological advancement. Most of these facilities have remained in their basic state, and have a weak infrastructure, even as regulations, GEPs, design philosophies, and construction techniques have advanced. This situation has positioned these facilities below the standards of what the “c” in “cGMP” always intended.

This type of dilemma ultimately manifests itself in massive compliance risks, lost profits, and loss of market share.  However, there are simple steps that can help you “stay ahead of the curve.”

This 90-minute interactive seminar will discuss the issues, design, and implementation of the following:

• Unidirectional flows and architectural layout
• HVAC upgrades, AHU modernization, segregation, isolation, and distribution
• Architectural finishes and upgrades
• Use of single use / disposables process systems
• Automation of portable systems
• Operational upgrades in the area of material handling

This course looks at key design features and philosophies that will drive compliance to a successful conclusion.  Additionally, this session will explore modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years, enhance compliance to current standards, reduce the operating risks, and provide more robust plant performance.

Finally, this seminar will explore the design concepts that are driving compliance and the operability of businesses globally. This course will explore these critical aspects from a design and compliance perspective, plus provide you with specific guidelines and direction.

LEARNING OBJECTIVES

At the conclusion of this 90-minute session, participants will be able to:

1. The “ABCs” of facilities enhancement – compliance-driven actions that get results
2. Focus on the removal of the sources of contamination and particulate generation
3. Design, engineering and construction “must do” items
4. Devising and implementing a bullet-proof plan: reach goals, set expectations, and lower costs
5. Develop flexible facilities that will allow your operations to scale without pain