2009 Annual Event Schedule

Committee Members: Committee Meeting Schedule

Sunday, 8 November
07.00 – 08.00	Charity Event - 5K Run/Walk*
12.30 – 15.00	Student Lunch/Orientation with Industry Speakers Developing Job Interviewing Skills
13.00 – 17.00	101 - Facility of the Year Category Award Winner Presentations
	102 - New Technologies in OSD
	103 - Combination Products: Considerations for Entering a New Market
	104 - Risk Assessment and Risk Management
	105 - Building Yourself an Ark: Tools for Controlling Stress to Help Workers Thrive and Survive in the Workplace
	106 - Logistics: Follow the Money/Material and the Impact on Unit Pricing
	107 - Implementing Quality Risk Management: Using Risk Assessment to Speed Your Way to Drug Approvals
	108 - The Real World of Project Management (Part 1 of 6): The Project Manager’s Playbook – Case Studies
15.00 – 16.00	Student Poster Set Up
17.00 – 18.30	Welcome Reception in Exhibit Hall – Open to all registered attendees

Monday, 9 November
07.00 – 08.30	New Member/First Time Attendee Orientation Breakfast
08.30 – 12.00	E01 - Keynote Session
10.15 – 13.15	Guest Package: Cruise and Brunch on the San Diego Harbor*
13.30 – 14.30	CPIP™ Introduction Workshop
13.30 – 17.00	Student Poster Competition
	201 - LEAN Quality: Applying Lean Thinking to Quality Systems & a Case Study: LEAN within Quality Assurance/ Quality Control at H. Lundbeck A/S
	202 - Case Study: Cephalon Master Plan and Renovation of Corporate R&D Headquarters, Westchester, PA
	203 - Survival - From A Manufacturer’s Perspective
	204 - Good Engineering Practice
	205 - Regulatory Hot Topics - Town Hall Forum
	206 - Process Analytical Technology (PAT) Used for PQLI^® and QbD: Implementation Update, Examples, and Discussion
	207 - Profitability through Sustainable Design [Green = Profit]
	208 - The Real World of Project Management (Part 2 of 6): The Project Manager’s Playbook – Project Conceptualization
	700 - Investigational Products (IP): Innovation in a Regulated Environment
15.00 – 16.00	CPIP How-to Workshop
17.30 – 21.30	Communities of Practice General Reception and Dinners*

Tuesday, 10 November
08.15 – 11.30	301 - Quality and Regulatory Challenges Relating to Development, Use, and Approval of Drugs for Medical Countermeasures
	302 - C&Q COP Pharma Manufacturers Risk Approach Task Team Forum
	303 - Ensuring the Integrity of the Global Supply Chain
	304 - Case Studies in Contained Active Pharmaceutical Ingredients (API) Pilot and Manufacturing Facilities
	305 - Product Quality Lifecycle Implementation (PQLI^®): Regional Regulatory Experiences Implementing the ICH Quality Vision
	306 - Validation Master Plan (VMP): Preparation, Applications, and Case Studies
	307 - Better Project Results Through Innovative Collaboration and Outsourcing
	308 - The Real World of Project Management (Part 3 of 6): The Project Manager’s Playbook – Project Design
	700 - IP: Innovation in a Regulated Environment (Cont.)
08.30 – 09.30	CPIP Introduction Workshop
10.00 – 14.00	Guest Package: Shopping in La Jolla or Strolling in Coronado*
10.30 – 11.30	CPIP How-to Workshop
11.45 – 13.45	Membership Luncheon and Awards Ceremony Student Poster Competition Winners Announced Student Chapter of the Year Announced
14.00 – 15.00	CPIP How-to Workshop
14.00 – 17.00	Affiliate/Chapter/Student Chapter Workshops for North and South America/Europe/Asia Pacific
14.15 – 17.15	401 - A Seamless Approach for Technology Transfer
	402 - Disposable Manufacturing Strategies, Impact on Design, Operations, and the Environment
	403 - Infrastructure Compliance Lifecycle
	404 - Anticounterfeiting – Can Chemistry Trump Bureaucracy?
	405 - Driving Improvement for Bioprocessing Operations
	406 - Product Quality Lifecycle Implementation (PQLI^®): Focusing on Q10
	407 - Current Outsourcing Trends in Bio-contract Manufacturing: The Impact on Pharmaceutical Engineers’ Productivity and Job Security
	408 - The Real World of Project Management (Part 4 of 6): The Project Manager’s Playbook – Project Construction
	700 - IP: Innovation in a Regulated Environment (Cont.)
19.00 – 22.00	Tuesday Night Party

Wednesday, 11 November
08.15 – 11.15	502 - Sustainability for Biotech Process
	503 - Dispelling the Part 11 Myths
	504 - The New NIH Design Requirements Manual for State-of-the-Art Biomedical Research Facilities
	505 - Continuous Pharmaceutical Manufacturing – Opportunities Now and in the Future
	506 - Sustainable Projects for Existing Facilities [Green = Profit]
	507 - Advanced Aseptic Processing
	508 - The Real World of Project Management (Part 5 of 6): The Project Manager’s Playbook – Project Commissioning and Qualification
	700 - IP: Innovation in a Regulated Environment (Cont.)
09.00 – 10.00	CPIP How-to Workshop
11.00 – 17.30	Optional Event #1: ISPE Golf Tournament
12.30 – 16.30	Optional Event #2: San Diego Zoo Tour*
12.45 – 15.45	602 - Critical Utilities – Guides, Hot Topics, and Sustainable Design
	603 - Life After GAMP^®5: What Comes Next?
	604 - Meeting Regulatory Need: The Challenge for Generics and CMOs and the Risk of Ignoring Warning Letters - Cancelled
	605 - Validating Per Annex 1
	606 - 21st Century Approaches for Reducing Manufacturing Costs During a Global Economic Crisis
	607 - The New Maintenance Good Practice Guide
	608 - The Real World of Project Management (Part 6 of 6): The Project Manager’s Playbook – Project Operations
	609 - Why the New OSD Guide is Vital
13.00 – 17.00	Optional Event #3: USS Midway and Aircraft Museum and City Tour*

*Minimum number of guests required or event may be cancelled