February 27-29, 2012 - Washington, DC

March 7-8, 2012, March 27-29, 2012 - Toronto, Canada

Day 1 - Wednesday March 7, 2012 
Finance for the Non-Financial Executive

Day 2 - Thursday March 8, 2012 
Foundations of Project Management

Day 3 - Tuesday March 27, 2012 
Strategic Planning

Day 4 - Wednesday March 28, 2012 
Balanced Scorecard and Presentation Skills for Leaders

Day 5 - Thursday March 29, 2012 
Marketing Management for Leaders

February 15, 2012 - Ottawa, Canada

The new FDA Guidance defines process validation as the “collection and evaluation of data, from the process design stage through commercial production”.  The Guidance has raised expectations for both planning and scientific study. As the FDA now states that process validation “involves a series of activities taking place over the lifecycle of the product”, we will determine which activities must necessarily occur during Phase 1, 2 and 3 clinical trials. Elements of the revamped 3-stage lifecycle approach include process design studies, proof of principle manufacturing and ongoing statistical analysis. This workshop will review the guidance and identify activities during clinical trials which are necessary to build the process validation package. We will address concepts such as:

• Critical Process Parameter Selection
• Process Modeling Activities
• Multivariate Analysis

• Analytical Methods
• Development of Acceptance Criteria
• Process Risk Analysis
• Process Monitoring

The workshop will review how to employ tools such as PDA Technical Report 42, ICH Q8/Q9 QbD, Risk Management, Quality by Design, Process Analytical Technologies and Statistical Process Control for all 3 stages of process validation. Firms invest deeply in process validation, we will review how to stage activities in order to realize the cost benefits and value from process validation activities. Implementing stage-appropriate best practices, will result in an optimized and fine tuned manufacturing process with data and results that speed the path to product licensure.

February 16, 2012 - Montréal, Canada

• Highlights of the ISO 14971 Risk Management Process
• Integrating 14971 into ERM
• Proper use of RPN
• ALARP, ALARA, Precautionary Principle
• Roundtable on RM in 60601 3rd edition
• Setting Risk Acceptability Criteria
• Use of Safety Cases to document Risk Management
• Common problems in the Risk Analysis step of Risk Management
• Issues in performing Overall Residual Risk Evaluation
• Connecting with other Quality System Processes
• Interfacing with Change Processes
• How Complaint processes should interface with Risk Management
• CAPA, Recalls, and Risk Management

April 24-26, 2012 - Orlando, Florida

• What are Health Canadian, US, and European guidelines for temperature control of drug products during storage and transportation?
• Cold Chain Transportation & Storage of Vaccines
• The Last Mile:
• Ensuring Cold Chain Integrity all the Way through to the Consumer or Health Care Provider
• Difference between "Monitoring" and "Controlling" Temperature:
• How Do You Control the Temperature of your Cool Chain Shipments in an Airfreight Transport Environment?
• Process Analytical Technology in Cold Chain
• Complyingand Applying USP <1079> "Good Storage and Shipping Practices"
• Methods and Solutions that Companies can use to Reduce their Costs in Cold Chain
• Using Risk Management Tools to Manage the Integrity of the Cold Chain
• Implementing Cold Chain Controls from Manufacturing to Distribution for Cold Chain Pharmaceutical Products
• Temperature Monitoring During Warehousing and Transportation
• International Focus: Import/Export Shipping Challenges and Best Practices
• Regulatory Update: Developments in Good Distribution Practice Regulations and the Impact on Clinical Supplies
• Cargo and Asset Management along the Cold Chain
• Advances in Container Refrigeration Technology
• Improving the Performance of Transport Assets & Cold Chain Infrastructure
• Best Practices in Pharmaceutical Cold Chain Management
• Cold Chain Challenges in a Continental-Sized Country: How to Face an Increased Demand Scenario
• Cold-Chain Logistics in Healthcare: A Modern Alternative Environment and Application Problem
• Evaluating an Inspector’s Perspective on Common Mistakes in Cold Chain Handling
• Definition of a Quality System for Temperature Controlled Pharmaceutical Distribution
• Air Cargo Transportation in the Temperature-Sensitive Healthcare Sector
• Minimizing Vaccine Damage During Distribution: A WHO Guideline
• Overcoming the Latest Pharmaceutical Cold Chain Management Challenges
• Evaluating Specific Challenges and Solutions in the Biopharma Cold Chain
• Identifying Innovative Solution for Airfreight Transportation in the Cool Chain
• Addressing Risks in Global Frozen Shipments of Biologics and Pharmaceutical Products
• Future Challenges of the Biopharma Cold Chain
• Ensuring Integrity of Products through Transportation
• Materials Used in your Sterile Barrier System for Shelf-Life Products
• Carbon Footprint: Methods and Solutions

WORKSHOPS:

• Developing a Compliant and Reliable End-To-End (E2E) Temperature Monitor Management Program (Mr. Jeffrey James, Merck)
• Air Cargo Transportation in the Temperature-Sensitive Healthcare Sector (Dr. Christelle Laot, FedEx)