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Date	Session Details	Add to Planner
Tue. May. 1	9:15 am - 10:15 am What the New Bio/Pharma Business Model Means for CMOs and CROs
Tue. May. 1	10:30 am - 11:30 am So You Need a Small Clean Room For….. So Where Do I Start?
Tue. May. 1	10:30 am - 11:30 am Case Study: Implementing Single-Use Technologies in a GMP Facility
Tue. May. 1	10:30 am - 11:30 am Panel Discussion: Best Practices and Regulatory Expectations in Continuous Processing
Tue. May. 1	10:30 am - 11:30 am Case Study: Regulatory Consequences from Poor Microbiological Manufacturing and Laboratory GMPs
Tue. May. 1	10:30 am - 11:30 am Guidance for Industry Process Validation: General Principles and Practices - A CMO’s Approach
Tue. May. 1	11:45 am - 12:30 pm Complex Single-Use Unit Operations: The Process and Economic Benefits
Tue. May. 1	11:45 am - 12:30 pm Innovative Technique for the Production of Drug Loaded Pellets
Tue. May. 1	11:45 am - 12:30 pm New Technology in Tablet Compacting
Tue. May. 1	11:45 am - 12:30 pm Flexible Aseptic Syringe and Vial Filling for CMO applications
Tue. May. 1	1:30 pm - 2:30 pm Control, Capability, and Capacity: Elements Assuring a Reliable Drug Supply
Tue. May. 1	2:45 pm - 3:45 pm Case Study: Optimizing Execution with Modular Construction
Tue. May. 1	2:45 pm - 3:45 pm Single Use Technology Enabling Biosimilar Manufacturing
Tue. May. 1	2:45 pm - 3:45 pm Learn theTechnical Challenges in the Development of Biosimilars
Tue. May. 1	2:45 pm - 3:45 pm Seven Things You Should Do Before Facing an Inspection
Tue. May. 1	2:45 pm - 3:45 pm Is Your CMO Committed to Your Success?
Tue. May. 1	4:00 pm - 5:00 pm Case Study: Greener Manufacturing with Reduce, Reuse, Recycle & Reclaim of Water
Tue. May. 1	4:00 pm - 5:00 pm Case Study: Use of Pre-Sterilized Single-Use Disposable Fluid Paths in Sterile Manufacturing
Tue. May. 1	4:00 pm - 5:00 pm Making Risk Assessment Part of Technology Transfer
Tue. May. 1	4:00 pm - 5:00 pm Case Study: An Enterprise-Wide Approach to Global Change Management
Tue. May. 1	4:00 pm - 5:00 pm Case Study: How to Benefit from Pharmaceutical Distribution Outsourcing
Wed. May. 2	9:00 am - 10:00 am Case Study: Meeting Sustainability Challenges with the Revamping of Your Wastewater Plant
Wed. May. 2	9:00 am - 10:00 am Case Study: Aspects of a Sustainable Maintenance for a Lifecycle Cleaning Validation Program
Wed. May. 2	9:00 am - 10:00 am Case Study: Designing Critical Cleaning Processes to Mitigate Microbial Risk in Multiproduct Facilities
Wed. May. 2	9:00 am - 10:00 am Learn Why Export Control on Processing Equipment is Important
Wed. May. 2	9:00 am - 10:00 am Why Deploying Lean Six Sigma is Important for Global Manufacturing Networks
Wed. May. 2	10:15 am - 11:15 am Creating Innovative Cold Chain Solutions for your Pharmaceutical and Biopharmaceutical Products
Wed. May. 2	11:30 am - 12:15 pm Facility Operation Intensification: In-Line Conditioning Buffer Preparation versus In-Line Dilution
Wed. May. 2	11:30 am - 12:15 pm On-line TOC Monitoring in GMP Parts Washers
Wed. May. 2	11:30 am - 12:15 pm Single-Use Coming of Age - Next Generation Systems and Advantages
Wed. May. 2	11:30 am - 12:15 pm Pragmatic Implementation of Single-use Technologies
Wed. May. 2	1:30 pm - 2:30 pm Case Study: Asset Optimization & Flexible Multi-Product Facility Concepts
Wed. May. 2	1:30 pm - 2:30 pm Case Study: Translating the New Process Validation Paradigm to Cleaning Processes
Wed. May. 2	1:30 pm - 2:30 pm Case Study: Why is Product and Process Understanding in Supporting Post-approval Change Important?
Wed. May. 2	1:30 pm - 2:30 pm Streamlining Risk Management Evaluations for New Manufacturing Processes
Wed. May. 2	1:30 pm - 2:30 pm Why Supply Chain Security is so Important in Today’s Marketplace
Wed. May. 2	2:45 pm - 3:45 pm Case Study: Why Logistics Modeling and Architectural Layouts is Important
Wed. May. 2	2:45 pm - 3:45 pm ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
Wed. May. 2	2:45 pm - 3:45 pm How to Use Online Analytics as a PAT Tool to Enable QbD in Upstream Cell Culture
Wed. May. 2	2:45 pm - 3:45 pm Proven Cost-Savings Using Manufacturing Execution Systems (MES) for BioPharm Manufacturers
Wed. May. 2	2:45 pm - 3:45 pm Appling a Knowledge-Based Approach to Supply Chain Pharmaceutical Temperature Control Management
Wed. May. 2	4:00 pm - 5:00 pm Implementing Commissioning and Qualification In Line with the FDA's Recent Process Validation Guidance
Wed. May. 2	4:00 pm - 5:00 pm Case Study: Path to Reduce Operational Expenses and Improve Operational Efficiency
Wed. May. 2	4:00 pm - 5:00 pm Bioburden Control for Sterile Filtration for Injectable Biotechnological and Pharmaceutical Drug Product Manufacturing
Wed. May. 2	4:00 pm - 5:00 pm Proven Processes and Metrics to Optimize Operational Excellence
Wed. May. 2	4:00 pm - 5:00 pm Regulatory Strategies and Considerations for Successful Site Transfers
Thu. May. 3	9:30 am - 10:30 am Practical Applications of Statistical Methods Under 2011 FDA Process Validation Guidance
Thu. May. 3	10:45 am - 11:45 am Making It in Massachusetts: A Small Company’s Road to the CMO Market
Thu. May. 3	12:00 pm - 1:00 pm Development of Novel CR Formulation Mitigating Dose Dumping & Misuse

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My Show Planner

Session Search

Conference sessions are all paid and require registration. Please sign up through INTERPHEX registration.Search for Sessions

Quick Lists

Badge Category

Track

Speaker

Follow @INTERPHEX

Latest Press Releases

Conference sessions are all paid and require registration. Please sign up through INTERPHEX registration.
Search for Sessions