Knowledge Summit 2011 - MAY 11th-13th - Alexandria, VA

BREAKOUTS DAY 1

Day 1 - Breakout Sessions (Concurrent)

Thursday, May 12 – 1:15 - 2:45

Session 1: Managing Training to External Communities... Latest Best Practices

During this interactive workshop, we will share the latest developments related to managing learning programs directed to external communities.  Specifically, we will look at knowledge flow to the following communities across both Life Science and General industries:

1. •Contract Sales/Brokers
   

2. •Suppliers
   

3. •Clients / Product Users
   

4. •Clinical Research
   

This workshop will focus on these areas:

Defining the Scope: Who Needs to Be Tracked?

1. •What external communities should you be reaching out to and why
   

2. •Mapping content needs to your audience and business/regulatory requirements
   

3. •Defining ownership of the training program (system, content, user data)
   

4. •Meeting both business goals and regulatory obligations
   

Mapping Your Technology Requirements

1. •Best practices for user maintenance procedures
   

2. •Integration with supplier systems, contact management systems, etc
   

3. •Defining reporting needs, audit needs, etc.
   

Demonstrating a Potential Solution

1. 1. •Administrative options for managing content and user/external partner data
      

   2. •Ensuring consistent user experience
      

   3. •Addressing security and personnel issues
      

   4. 
      

   Who Should Attend?
   

   This workshop is designed for any Quality, Training or Compliance executive who is overseeing the training related to non-employees, especially in the areas of outside sales and suppliers.
   

   
   

   
   

   Session 2: Risk Assessment Workshop
   

   Regulatory compliance is defined as continuously meeting the requirements (regulations) as they pertain to the product or services which your company provides. This involves identifying and managing risks which might result in failure to comply with a particular regulation. Standard Operating Procedures are a key tool used in ensuring standardization of activities and behaviors within an organization. This breakout session will be facilitated by Karen Ginsbury and focus on risk management and commonly used risk assessment methods and tools.
   

   Ms. Ginsbury will use practical, interactive exercises to show how to apply risk management tools that apply to both pharmaceutical/medical device manufacturing and environmental risks. For those who want to prepare for this workshop – George Orwell wrote an essay entitled “A nice cup of tea.” To illustrate the process of risk assessment, we are going to rank the risks associated with making a cup of tea and at the same time think about writing a Standard Operating Procedure that always works. To be discussed:
   

   1. •Risk inducing factors
      

   2. •Risk Ranking
      

   3. •Critical Control Points
      

   4. •Using Risk Communication to ensure procedures are followed
      

   5. •Risk Monitoring and Review
      

   Who Should Attend?
   

   This session is designed for professionals focused on assessing and managing risk issues within their organizations. Anyone involved with evaluating Quality, Training or Compliance would benefit from attendance.