Utilization of a Lifecycle Validation Approach via a Quality System to Reduce Costs and Increase Compliance

Instructor: James Carron
Product ID: 703412
  • Duration: 90 Min

recorded version

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This webinar will explain how to incorporate a quality system into the validation process to reduce cost and ensure compliance. It will cover the analysis, design and initiation phases, including full implementation of the incorporation.

Why Should You Attend:

The growth of the pharmaceutical, biotechnology and medical device industries is addressing not only the aging population but an ever changing landscape of what technology can do to lessen the suffering of mankind from disease, injuries and aging. The international regulatory landscape is becoming more complex and is struggling to keep up with changing technological advances. As a result, companies must have a cost-effective approach to validating their business processes, facilities, automation (IT) as well as distribution channels.

This webinar will detail how to implement tools that will result in a more responsive cost-efficient approach to validation activities. This approach will allow for better senior management accountability and corporate governance as well as the identification of responsible (accountable stakeholders) individuals for these validated processes.

Areas Covered in the Webinar:

  • Assessment of current departmental structures and company efficiencies, as well as compliance deficiencies
  • Analysis phase where are the business silos and a chance to create synergies
  • Design phase of the incorporation of the quality system into the validated systems
  • Initiation phase of the incorporation
    • Pilot phase
    • Scale-up phase
    • Full implementation
  • Governance oversight( Executive Accountability)
    • Company Communication
    • Rewards and Recognition
    • Business Expansions
  • Case Studies

Who Will Benefit:

  • Senior Management Executives
  • Operations Executives
  • Supply Chain Executives
  • Quality Assurance Executives
  • Regulatory Compliance Associates and Managers

Instructor Profile:

James Carron, has a BS in Chemistry/ Mathematics from Missouri State University who has over 26 years of industry management experience including Validation, Quality Control, Quality Assurance, and Research and Development, and Supply Chain. His experience includes pharmaceuticals (aseptic and solid dose), medical devices, and biotech products. He served as remediation project manager for Consent decrees and Warning Letters as well as creating operational efficiencies.

He has spent last six years doing the quality oversight for Amgen SAP implementation. Currently he is an independent consultant in the areas of compliance, validation, quality assurance and quality control as well as cost containment.

Topic Background:

The pharmaceutical industry and many other industries recognize that employees must follow a distinct code of conduct. A company must have a policy and or procedure(s) that define a code of conduct. The Quality Systems Regulation 21 CFR part 820, which was originally a regulatory requirement for the medical device industry, was instituted across all of FDA regulated industries.

Many companies fail to engage the quality system in day to day business practices. As a result, the validation of non-related business processes may result in regulatory liabilities. In addition, by not engaging the quality system, the validated system may not be governed by adequate change control.

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