Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.
Why Should You Attend:
This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. This often results in a savings of two-thirds the cost. Additionally, this course will help companies increase compliance and demonstrate how to use risk management to improve system performance and promote process improvement.
Areas Covered in the Seminar :

• Learn which documents the FDA expects to audit.
• Proven techniques that reduce software costs and implementation times.
• Increase corporate productivity and individual workforce member productivity.
• Efficiently create validation documentation.
• Decrease resource requirements.
• Make documentation more manageable and understandable.
• Avoid 483s and Warning Letters.
• How to implement a computer system to gain maximum productivity.
• Use resources effectively to perform effective validation while avoiding doing too much.
• How to link requirements, specifications, risk management, and testing.
• Document a computer system validation project using easy to understand fill-in-the-blank templates.
• Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).

In this Food Recall training learn how to create a crisis response plan, data gathering, investigation phase specifics and how to communicate under different scenarios.
Why Should You Attend :
Reacting is the norm but anticipating and preparing are what's needed. Creating a robust process that will protect both the consumer and the company's reputation requires careful planning and the active involvement of each department. Another crucial element is communication, with the public as well as customers and shareholders. The risk posed by the product is one important element but anticipating the consumer's reaction is key. Whether they respond with disinterest to a serious hazard versus outrage requires a different communication strategy. As well, the messages sent at the outset of the recall will be different than when the regulator gets involved and different again as the recall reaches a conclusion.
The course will describe how to create the most comprehensive Recall Plan (or Crisis Response Plan).Once the process has been documented we will review the Data Gathering / Investigation phase specifically and give examples of microbiological studies (e.g. Listeria monocytogenes) important issues to be remembered. We will discuss what are the best practices of an effective crisis communication. We will discuss the roles and approaches under different crisis scenarios.
Areas Covered in the Seminar :

• Why should we have a Crisis Response Plan.
• How to create a flow diagram of the steps in a product recall.
• Develop list of team members' roles and responsibilities at each step.
• Understand product recovery vs product recall and its classification.
• Example of the recent product recall and its trickledown effect.
• Example of investigation process of a Listeria outbreak.
• Review the best practice for effective Crisis Communication.
• Outline the responses / approaches based on a variety of crisis scenarios.
• Questions and discussion: What do you see your role to be and the others in your company and add suggestions.

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