• Complying with Regulations and Current Guidance (ISO, FDA, GMP, ASTM, ISPE)
• Facility design concepts related to current Good Manufacturing Practices (cGMPs)
• Design and Construction of Critical Utilities-Water, Gas, HVAC
• Integration of Commissioning, Qualification and Validation
• Installation, Operational and Performance Qualification of Equipment
• Managing Facility Change Control
• Facility Design Considerations for Oral Solid Dosage Facilities
• HVAC: Design, Control & Validation
• Current industry standards for utilities such as water, pharmaceutical gases & Cleanroom HVAC
• Considerations for Upgrading/Modifying Existing Biotech Facilities
• The Design Review Process for HVAC systems
• Pharmaceutical Water Systems: Design, Control & Validation
• Complying with USP, EP, FDA Requirements for Pharmaceutical Water Systems
• Regulatory Considerations Related to an Expansion Strategy
• Performance Qualification and Ongoing Monitoring of Water systems
• Validation of High Purity Water Systems
• Streamlining the Commissioning and Qualification Process for Water and Steam Systems
• GMPs for Critical Equipment – IQ, OQ, PQ
• Project Management strategies - Identifying total project deliverables
• Manufacturing Facility Design: Flexibility for Multiple Product

Interactive Case Study and Workshop Sessions:

• Performing a System & Component Level Impact Assessment
• Designing an OSD Facility
• Existing Facilities - Strategic Total Rebuild of a Biopharmaceutical Plant
• Modular Construction of a Pharmaceutical Facility

This two-day seminar and workshop series is dedicated toward Directors, Managers, Supervisors, Analysts and Associates in the Pharmaceutical, Biopharmaceuticals, Medical Device and allied industries with daily responsibilities in the following areas:

• Facilities Management
• Facility Monitoring
• Validation
• Engineering
• Technical Operations
• Change Control
• Production
• Construction
• Manufacturing
• Quality Assurance
• GMP/GLP Compliance
• Project Management
• CAPA Coordination
• Regulatory Affairs
• Training
• Documentation and Technical Writing
• Contract Laboratories
• Contract manufacturing