Annual Meeting Program

Sunday, 6 November
13.00 – 17.00	101: Advanced Aseptic Processing Utilizing RABS and Isolators
	102: How to Succeed with Facility Capital Investments in China
	104: The New Workplace: New Trends in the Design of the Office and Laboratory Workspace for the Pharmaceutical and Biotechnology Industry
	105: Critical Utilities
	108: Project Management: Planning for Expansion
17.00 – 19.00	Welcome Reception in the Exhibit Hall

Monday, 7 November
06.00	Charity 5K Run/Walk
07.00 – 08.15	New Member/First Time Attendee Orientation Breakfast
07.00 – 17.00	Exhibit Hall Open
08.30 – 12.00	Keynote Session
13.30 – 14.30	CPIP™ Introduction Workshop
13.30 – 17.00	201: Aseptic Processing: The Future of Technology, Regulations, and Manufacturing Operations
	202: Secrets to Successful Manufacturing Facility Projects in BRIC Countries
	203: Introduction and Overview of the New ISPE Quality Risk Management Guidance Documents for C&Q
	204: Making Sustainability Pay: Lessons Learned and Best Practices
	205: Regulatory Affairs Forum
	206: Supply Chain Integrity and Brand Protection for Healthcare Products
	207: Operational Excellence - A Foundation for Quality
	208: Project Management: Identifying the Best Resources to Fit Your Projects’ Needs
	700: Mission Critical: Supply Chain Optimization in a Regulated Environment (Part 1 of 4)
17.30 – 19.00	COP Night Pre-Game Party
19.30 – 21.30	COP Night Dinners
19.30 – 22.00	Young Professionals Networking Dinner (off-site at Austin Ranch)

Tuesday, 8 November
07.00 – 11.00	Exhibit Hall Open
08.15 - 11.30	301: Current Trends in Disposable Applications
	302: Delivering Manufacturing Facilities in Asia: Market Understanding and Risk Management
	303: Pharma Manufacturer’s C&Q Risk Approach Task Team Forum III - Process and Practices
	304: 2011 Facility of the Year Awards Category Winners Presentation
	305: Launching the QbD Series and Implementing ICH Q10: Moving Pharma Quality Systems Program Forward
	306: Pharmaceuticals in the Environment: A Regulatory Perspective
	307: Automated System Testing: Driving Process Performance and Data Integrity Part 1
	308: Project Management: Establishing Best Methods of Communication for Your Projects
	700: Mission Critical: Supply Chain Optimization in a Regulated Environment (Part 2 of 4)
08.30 – 09.30	CPIP™ How-To Workshop
11.45 – 13.45	Membership Luncheon and Awards Ceremony
14.15 – 17.15	401: Advancements in API Process Technology
	402: GMP and CMC Regulations in Asia: Modernizing Initiatives and Current Regulatory Environment in China, India and ASEAN Markets
	403: Beyond ICQ: An ASTM E2500, Verification Leveraging, Project Profile
	404: 2011 Facility of the Year Awards Category Winners Presentation (continuation from Monday session)
	405: PQLI^®/PAT - Moving Beyond ICH Q8, 9, and 10 Concepts: Biotech QbD Realization Case Studies Leveraging PAT
	406: Supply Chain Integration to Maximize Profits and Compliance
	407: Automated System Testing: Driving Process Performance and Data Integrity Part 2
	408: Project Management: Keeping Your Project Team Going in the Right Direction
	700: Mission Critical: Supply Chain Optimization in a Regulated Environment (Part 3 of 4)
15.30 – 16.00	Poster Presentations
19.00 – 22.00	Tuesday Night Party at the Glass Cactus

Wednesday, 9 November
08.00 – 12.00	501: Disposables - Early Phase / Clinical Manufacturing Approach Utilization Disposable Applications
	502: Pharmaceutical Manufacturing in Central and Eastern Europe
	503: Early Stage Planning and Overall Project Controls for Large C&Q Projects
	504: Combining Commissioning and Qualification: A Non-Conventional Streamlined Validation Approach
	505: OSD - Don’t Let the Process Control You!
	506: Green OSD Pharmaceutical Production
	507: Product Supply and Network Challenges in Latin America
	508: Project Management: Keeping the Peace—the Project Manager’s Role in Dispute Resolution
	700: Mission Critical: Supply Chain Optimization in a Regulated Environment (Part 4 of 4)
10.00 – 10.30	Poster Presentations

Training Courses
Wednesday, 9 November and Thursday, 10 November
08.30 – 17.00	Risk-Based Approach to GxP Process Control Systems (T21)
	Modern Approaches to Risk-Based Commissioning and Qualification (T40)
	Managing the Risk of Cross Contamination (T41)