In this Medical device recall training learn how to interface with FDA in regards to anticipated recalls, the communication, the response, how to prepare the public information.
Areas Covered in the Seminar :

• Recent product recall failures.
• Analyzing product risks.
• CAPA prioritization.
• Communicating with FDA.
• Deciding on the response.
• Preparing the public information.
• Notifying the customers.

Who Will Benefit :

• Medical Device managers
• CAPA Managers
• Quality Managers
• Regulatory Compliance Managers
• Product Management
• Public Relations personnel
• Marketing Management

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This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten the time for implementing pre and post approval changes.
Areas Covered in the Seminar:

• Important factors to know in order to use Comparability Protocols:
  • What are Comparability Protocols?
  • What are the benefits of using Comparability Protocols?
  • When might a Comparability Protocol be useful for a CMC Change?
  • What about pre-approval changes?
  • When might a Comparability Protocol be inappropriate to use?
  • How should a Comparability Protocol be submitted?
  • What happens after submission?
  • What are the basic elements of a Comparability Protocol?
  • How much Risk Potential can be reduced by using a Comparability Protocol?
  • New and expanded uses for Comparability Protocols.

For More Details :

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701315?channel=webcentral
Contact Number: 650-620-3915
Email: admin@complianceonline.com

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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