This validation training will discuss FDA impacts and approaches for compliance for use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing.
Areas Covered in the Seminar:

• Tougher FDA and EU MDD Software V&V Expectations.
• Key COTS Software Apps V&V Requirements .
• Problem Areas.
• Product, Equipment/Process, QMS and Apps Software and Part 11 Requirements .
• Realistic Limits of Apps Software V&V .
• Suggested Approaches.
• How to Implement, Execute and Document.
• Proper Risk Allocation of Scarce Resources.

Who Will Benefit:
This webinar will provide valuable assistance to personnel in all regulated companies responsible for software validation under the cGMPs and EU MDD/CE-marking. This information applies to personnel / companies in the FDA-regulated industries, e.g., Devices, Pharmaceutical, Diagnostic, Biologics and Dietary Supplements. The employees who will benefit include:

• Senior management
• Regulatory affairs
• Quality Assurance / QAE
• Production
• Software Implementers
• Engineering
• Sales and Marketing
• All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD -regulated environment

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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).

This FDA cGMP training webinar will discuss US FDA's approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate.
Why Should You Attend :
Recent audits indicate the past ways of doing things will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. Recent headlines indicate a public's growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA. How this is affecting the Agency's approach to audits and their expectations for companies. Pressure on the 510(k) process is only one example. How they drive companies to do much of their work for them. We will evaluate the chief areas of an FDA CGMP compliance audit to see actual and anticipated changes in emphasis based on this new regulatory climate.
Areas Covered in the Seminar :

• The "target".
• Avoid complacency from past "good" FDA audits.
• Avoid complacency from just completed "good" ISO audits.
• The desired response.
• How to respond now -- where to shift focus first.
• Where to direct scarce resources.
• A risk-based phased approach.
• Maintain 'the edge'.

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