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Schedule-at-a-Glance

Manufacturing Technology Young Professionals
Manufacturing Facilities & Design Super Sessions or Executive Series
Investigational Products Technical Showcase
Information Systems Project Management
Global Regulatory and Compliance Quality Systems

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Saturday, 11 October [ Back to Top ]
17:30 - 19:00 Leadership Reception (by invitation only)
Sunday, 12 October [ Back to Top ]
13:00 - 15:00 Closure Processing: Container Integrity, Blow/Fill/Seal
13:00 - 15:00 Operations-Focused Quality System Optimization
13:00 - 15:00 Developments in Global Harmonization
13:00 - 15:00 Risk - Part I
13:00 - 15:00 Operational Excellence: Facility Master Planning, Manufacturing Capacity and Cost Modeling
13:00 - 15:00 Case Study - New High Purity Water System Technologies Deliver Reliability & Sustainability for GSK
15:30 - 17:00 Opening Keynote
17:00 - 19:00 Welcome Reception in Exhibit Hall
Monday, 13 October [ Back to Top ]
07:00 - 08:00 6th Annual ISPE Charity 5K Run/Walk
08:00 - 09:30 Keynote Session
09:30 - 10:15 ADM Concepts as a Model for Next Generation Biomanufacturing
09:30 - 11:00 Demand Flow - A Unique, Proven & Holistic Energy & Operational Cost Savings Application for Water-Cooled, Central Chilled Water Systems
09:30 - 11:00 Risk - Part II
09:30 - 11:00 Models for IT Infrastructures and Agile Development
09:30 - 11:00 Oral Solid Dosage Manufacturing Facilities
09:30 - 11:00 How Good is Your Auditing System?
09:30 - 11:00 Voltage Optimization: Energy Management & Sustainable Solutions
09:30 - 11:00 Quality Management Systems: A Guide to Monitoring End-to-End Product Health
09:30 - 11:00 C&Q: Fulfilling Stage 2A of the FDA Process Validation Guideline - Part I
09:30 - 11:00 Manufacturing Reliability and Integrated Manufacturing Control Strategy
09:30 - 11:00 Managing Assets and Equipment for Reliable Drug Supply
10:15 - 11:00 Design Assessment Model for Pharmaceutical Drug Manufacturing Facilities
10:30 - 12:30 Exhibit Hall & Lunch
12:30 - 14:30 Advanced Aseptic Processing - Part I
12:30 - 14:30 Solutions for QbD and ASTM E2500 Implementation
12:30 - 14:30 Data Integrity - Part I
12:30 - 14:30 EXECUTIVE SERIES: FOYA CATEGORY WINNERS - PART I
12:30 - 14:30 C&Q: Fulfilling Stage 2A of the FDA Process Validation Guideline - Part II
12:30 - 14:30 Modeling within the QbD Framework & Lifecycle Considerations - Part I
12:30 - 14:30 Reliability Centered Design Principles Reduce the Life-Cycle Cost of Assets and Improve Speed to Market - Part I
12:30 - 14:30 Environmental Control & Sustainability - Part I
12:30 - 14:30 Disposables 101
12:30 - 14:30 Don't Gamble Your Project Away:
Real World Lessons of Project Management Top Ten Lessons Learned: A Study in Project Management
12:30 - 14:30 Betting on the Future: The Next Generation of Investigational Products - Part I
ACPE UAN: 0012-9999-14-242-L04-P
14:30 - 15:30 Networking Break in Exhibit Hall
15:30 - 17:30 Operational Excellence: Strategies for Readiness
15:30 - 17:30 Advanced Aseptic Processing - Part II
15:30 - 17:30 Symposium on Process Capability: A Leading Quality Metric?
15:30 - 17:30 EXECUTIVE SERIES: FOYA CATEGORY WINNERS - PART II
15:30 - 17:30 Data Integrity - Part II
15:30 - 17:30 Betting on the Future: The Next Generation of Investigational Products - Part II
ACPE UAN: 0012-9999-14-242-L04-P
15:30 - 17:30 Calculating Odds of Success: A Workshop on Project Management
15:30 - 17:30 Reliability Centered Design Principles Reduce the Life-Cycle Cost of Assets and Improve Speed to Market Education - Part II
15:30 - 17:30 Environmental Control & Sustainability - Part II
15:30 - 17:30 Modeling within the QbD Framework & Lifecycle Considerations - Part II
19:30 - 22:00 Young Professionals Networking Event at Margaritaville
Tuesday, 14 October [ Back to Top ]
08:15 - 09:30 Investigational ProductsTechnology and Innovation - Part I
ACPE UAN: 0012-9999-14-243-L04-P
08:15 - 09:30 Sustainability: Facility Engineering and the True Cost of Water
08:15 - 09:30 Starting Your Project with a Plan:
08:15 - 09:30 Project and Operating Challenge: Why are GCP Systems different (or not?)
08:15 - 09:30 Current Status and Trends on Serialization and Track&Trace Part I
08:15 - 09:30 Data Integrity - Part III
08:15 - 09:30 EXECUTIVE SERIES: Solutions for Manufacturing of the Future - Part I
08:15 - 09:30 BIO-QbD - Part I
08:15 - 09:30 Blow-Fill Seal Technology - Part I
08:15 - 09:30 Addressing Challenges in Implementation of the Lifecycle Approach to PV - Part I
08:15 - 09:30 Key elements of a Quality System
09:30 - 10:15 Networking Break in Exhibit Hall
10:15 - 11:30 Should All Quality Processes Move to the Cloud?
10:15 - 11:30 Blow-Fill Seal Technology - Part II
10:15 - 11:30 Addressing Challenges in Implementation of the Lifecycle Approach to PV - Part II
10:15 - 11:30 BIO-QbD - Part II
10:15 - 11:30 EXECUTIVE SERIES: Solutions for Manufacturing of the Future - Part II
10:15 - 11:30 Current Status and Trends on Serialization and Track&Trace - Part II
10:15 - 11:30 Data Integrity - Part IV
10:15 - 11:30 Designing for Operational Excellence
10:15 - 11:30 Procurement on Trial: A Workshop on Project Management
10:15 - 11:30 Steam System Optimization & Efficiency
10:15 - 11:30 Investigational ProductsTechnology and Innovation - Part II
ACPE UAN: 0012-9999-14-243-L04-P
11:30 - 13:00 Exhibitor Lunch and Featured Speaker
11:30 - 13:00 Membership Luncheon
13:00 - 14:30 Quality Culture & Continuous Improvement - Part I
13:00 - 14:30 Single-Use Technology can give you a fast moving scale-up of your process - but did you miss anything in the frenzy? - Part I
13:00 - 14:30 Blow-Fill Seal Technology - Part III
13:00 - 14:30 Current Status and Trends on Serialization and Track&Trace Part III
13:00 - 14:30 EXECUTIVE SERIES:
Baxter Healthcare Corporation- Integrated Plasma Protein Manufacturing Facility: Mid-Term Report
13:00 - 14:30 Drug Shortages
13:00 - 14:30 Application of the Lifecycle Approach to PV to Continuous Manufacturing and FDA Perspective of Lifecycle Approach to PV Implementation Progress
13:00 - 14:30 Investigational ProductsTechnology and Innovation - Part III
ACPE UAN: 0012-9999-14-243-L04-P
13:00 - 14:30 Process/CIP/SIP Integration for Operational Sustainability
13:00 - 14:30 Developing a Risk Assessment Based Culture to Streamline the Project Lifecycle: A Study in Project Management
13:00 - 14:30 Competencies: A Strategy to Eliminate 483/Regulatory Observations
14:30 - 15:30 Networking Break in Exhibit Hall
15:30 - 17:00 Quality Culture and Process Improvement - Part II
15:30 - 17:00 Single-Use Technology can give you a fast moving scale-up of your process - but did you miss anything in the frenzy? - Part II
15:30 - 17:00 Lifecycle Approach to PV Stage 3a and 3b - Case Studies
15:30 - 17:00 EXECUTIVE SERIES:
FIT Talk Series: Lessons Learned from 4 Decades of Biomanufacturing
15:30 - 17:00 How well do you Maintain Control of your Computer Systems?
15:30 - 17:00 Critical Utilities 101
15:30 - 17:00 Risk Assessment Tools and their Application: A Workshop on Project Management
15:30 - 17:00 Innovative Facility Delivery Methods - Gain Acute Understanding of Op Excellence & Best Practices Leveraged from Related Manufacturing Industries
15:30 - 17:00 Investigational ProductsTechnology and Innovation - Part IV
ACPE UAN: 0012-9999-14-243-L04-P
15:30 - 18:00 Metrics
15:30 - 18:00 Containment of Potent Compounds - Technology & Design Best Practices & Lessons Learned
19:00 - 22:00 Tuesday Night Party at Hakkasan Nightclub
Wednesday, 15 October [ Back to Top ]
08:00 - 09:15 Investigational Products: Hot Topics and Industry Updates - Part I
08:00 - 09:15 Hot Technologies: Mobile Applications and Strategies for Managing Software Risks in the Cloud
08:00 - 09:15 Global Expectations for Process Validation
08:00 - 09:15 Project Capital Efficiency: A Workshop in Project Management
08:00 - 09:15 Critical Utilities 102
08:00 - 09:15 Biopharmaceutical Process Carbon Modeling & Optimization
08:00 - 09:15 Critical Utilities COP Overview - Part I
08:00 - 09:15 Continuous Manufacturing - Part I
08:00 - 09:15 Translating Laboratory Developed Visible Residue Limits (VRL) to the Manufacturing Floor
08:00 - 09:15 Latin American Regulatory Compliance - Part I
08:00 - 09:15 EXECUTIVE SERIES: Operational Excellence - Part I
09:15 - 10:30 Brunch in Exhibit Hall
11:00 - 13:00 Critical Utilities COP Overview - Part II
11:00 - 13:00 Cleaning Validation: IMP Products, Bio Facility, Quantitative Image Processing
11:00 - 13:00 EXECUTIVE SERIES: Operational Excellence - Part II
11:00 - 13:00 Latin American Regulatory Compliance - Part II
11:00 - 13:00 Continuous Manufacturing - Part II
11:00 - 13:00 Tools for Achieving and Mantaining Operational Excellence
11:00 - 13:00 The T.R.U.E. Cost of Project Safety
11:00 - 13:00 Strategies for Enhanced Quality and Security
11:00 - 13:00 Investigational Products: Hot Topics and Industry Updates - Part II
11:00 - 18:00 Golf Tournament at Angel Park
13:00 - 18:00 Hoover Dam Tour

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