Education Sessions
E-GU5
ISPE Baseline® Guide – Volume 2, Oral
Solid Dosage Form
| 7 November 13.00-16.00 | Track: Guides & Guidance Documents |
ISPE CEUs: 0.2
Learn how this Baseline Guide has been rewritten extensively to cover advances in equipment and process technology, as well as the latest regulatory expectations to help you deliver today as you plan for tomorrow.
Many oral solid dosage (OSD) facilities run multiple products in processing areas designed for quick turnaround without unacceptable risk of product exposure or cross-contamination. Additionally, potent or toxic active ingredients are becoming increasingly common and present their own design challenges.
The Oral Solid Dosage Baseline Guide assists professionals by establishing consistent and minimum parameters for facility design. These key concepts are a basis for this Guide and its revision:
- Proper application of facility design and procedures to provide GMP compliance
- Risk-based approach
- Non-GMP technology and its impact upon facility design and costs
- Design conditions versus operating range
- Good engineering practice
- Enhanced documentation
This session presents the new key features and provides appropriate case studies to highlight their applications.
Take Back to Your Job
- Understand the use of risk management and risk assessment approaches within the lifecycle of the facility design and construction project
- Know how the proper balance of facility design and procedure allow the flexibility to design for appropriate levels of protection
- Know new technologies such as PAT and global regulatory perspective on the Guide
Who Should Attend
Pharmaceutical professionals engaged in planning, design, construction, and qualification of new oral solid dosage (OSD) facilities, or major renovations of existing facilities.
Session Leaders
- Werner Seiferlein, Director, Project & Technology, Sanofi Aventis Deutschland GmbH
- Stephen Yu, Principle Process Engineer, BE&K - Delaware
Session Speakers
- Michael DeBellis, Lead Process Mech Engineer, Jacobs Engineering Group Inc
- Richard Denk, Director, Pharma Dept, Hecht Technologie GmbH/KmpT AG
- Paul Gerard, Sr Mechanical Engineer, Delaware Eng'g & Design Co
- Gary Johnson, Consultant, Workplace Exposure Solutions LLC