ComplianceOnline

Building and institutionalizing risk management into the pharmaceutical supply chain

Instructor: Hedley Rees
Product ID: 702015
  • Duration: 60 Min

recorded version

$299.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

The webinar will explain how the pharmaceutical industry stakeholders can build and institutionalize risk management processes across the end-to-end supply chain, to secure compliant, risk mitigated supply chains able to compete on a world stage in terms of quality, cost and delivery performance.

Why Should You Attend:

Never has the pharmaceutical supply chain been subject to such challenge – issues of product adulteration, counterfeiting, poor compliance records and multiple opportunities for error have become endemic in the industry. Even US congress is deeply concerned following the Consent Decree raised against J&J/McNeil.

This webinar aims to get at the heart of why we are experiencing increasingly dysfunctional outcomes within the supply chains for pharmaceutical and biopharmaceutical products. The seeds of these issues are sown early on, in drug discovery and development, and carry-on forward into today's complex commercial supply chains. To counter this concerning trend, the webinar discusses how scientific, technical and managerial staff can build and institutionalize risk management approaches (as advocated in ICH Q9) into the drug development and commercialization process.

The webinar will show how you can institutionalize risk management as early as possible in the development process, ideally in pre-clinical project teams, and then building risk management activities into the routine of drug development project plans and company objectives.

Learning Objectives:

  • Develop a ‘root cause' view of the reasons for supply chain risk in the industry and the specific corrective and preventative actions (CAPA) required to put things right.
  • Identify how critical activities, undertaken in early stage drug discovery and development, can play a pivot role in reducing risk. This includes exploring how QbD/PAT can be an important enabler.
  • Discover effective strategies whereby industry practitioners can personally influence superior supply chain outcomes through the support and application of professional supply chain management (SCM) competencies.
  • Learn how to harness powerful models in Strategic Procurement, to build strong suppler relationships and cross-business alliances, delivering greater end-to-end supply chain visibility/traceability, more effective change control and improved resource productivity.

Areas Covered in the Webinar:

  • Understand the process of risk management as recommended by the International Conference on Harmonisation (ICH) guidance on Risk Management, ICH Q9, and the associated benefits of using such an approach.
  • Be able to link their own particular circumstances to the wider product development and business environment risks, so as to maximise their own personal contribution to the organisation and also the contributions of colleagues.
  • Have a clear understanding of the Regulatory expectations for risk management in the pharmaceutical industry of the 21st century.
  • Develop an integrated view of risk through the application of powerful tools and processes that result in full ‘buy-in' to mitigation plans from key stakeholders.
  • Take back to their work setting new approaches towards risk and ways of operating in project team and wider organizational issues.
  • Learn how the application of supply chain management (SCM) competencies can dramatically reduce risk of failure in the supply chain.
  • Feel far more confident that they understand risk management as an integral part of their regular operations, rather than an ad hoc event.

Who Will Benefit:

Management & professionals in the following disciplines:

  • Research chemistry and biochemistry
  • Chemical and biochemical engineering
  • Manufacturing, and controls
  • Preclinical & Clinical development
  • Regulatory affairs
  • Quality assurance
  • Finance
  • Marketing, Business development
  • Informatics and information systems
  • Licensing
  • Pharmacovigilance
  • Purchasing, Procurement, Supply management and Logistics
  • Operations, Production management
  • Inventory management and control
  • Warehouse management
  • Import/export
  • General management
  • Investors – VCs & private equity
  • Lawyers

Instructor Profile:

Hedley Rees, is author of “Supply Chain management in the Drug Industry” and is a practicing consultant, coach and trainer, operating through his company Biotech PharmaFlow. He helps companies build, manage and improve their clinical trial and commercial supply chains.

Prior to his time at Biotech Pharmaflow, Hedley held senior supply chain management positions at Bayer, British Biotech, Vernalis, Johnson & Johnson and OSI Pharmaceuticals. He holds an Executive MBA from Cranfield University School of Management and is a corporate member of the UK's Chartered Institute of Purchasing and Supply (MCIPS). He is also a member of the UK BioIndustry Association's Manufacturing Advisory Committee, regularly speaks at international conferences and is co-chair of this year's FDA/Xavier University sponsored Global Outsourcing Conference in Cincinnati. His specific interest is in helping drive industry improvements through the regulatory modernization frameworks of FDA and ICH Q8 - Q10. He believes that along with the regulatory guidelines, it is imperative that companies developing and selling drugs make a massive cultural and mindset shift to enable improvements to stick.

She shares unique insights gained from fifteen years experience in clinical trial conduct, validation, quality control, data management systems, post approval market surveillance, supplier management and regulatory compliance in the areas of biopharmaceuticals, medical devices and public utility/power generation industries.

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