Education Sessions

Supporting Strategic Initiatives with Operational Excellence (301)

26 October 13.00-17.00 Track: Manufacturing Operations

ISPE CEUs: 0.4

agenda(PDF Current as of 22 September 2008)

The pharmaceutical industry is currently undergoing a major business transformation driven by a combination of global regulatory requirements, operational constraints, and growing pressure to reduce the cost of pharmaceuticals to the public. Industry’s transformation is affecting operations across the board.

Listen to case history presentations from your peers. These include enterprise knowledge management and a detailed case study of an ongoing operational excellence program. In this presentation, the journey to Class A includes the rollout of business process management, ownership of global processes, and process improvement of issues, which are identified through quarterly assessments using a variety of tools and methodologies. Additionally, review the implementation and deployment of a risk management and six sigma program with actual industry examples. Join in the panel’s discussion on global market and business trends and how they impact development and manufacturing operations and performance. Challenges such as industry advancements in technology, the importance of such tools as Six Sigma and other strategic tools, as well as the significance of optimizing operations and business performance improvements in real time are also addressed.

How You Will Benefit

At the end of this session, participants will be able to:

  • Understand how operational and business excellence leads to strategic improvements
  • Establish a real connection from the business to the plant while enabling process improvements
  • Apply what professionals in the pharmaceutical, biotechnology, and other industries are doing
  • Explain why knowledge management is important to Operational Excellence
  • Understand how others are using tools and methodologies for implementation and deployment
  • Describe examples of how others are creating value and strategically improving throughput, yields and quality while reducing costs and mitigating risks
  • Understand how strategic initiatives support your business and lead to operational excellence

Who Should Attend

Pharmaceutical, biotechnology, contract and generic manufacturers, and anyone from the engineer to the vice president of quality or operations and supply chain should attend to learn how industry advances impact business, and how they can implement and sustain programs that support strategic initiatives and develop operational excellence

ISPE Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API) and Biotechnology (Biotech)

Proposed Agenda

  • Pharmaceutical Industry Strategy: Enabling Business Strategies (Case Study)
  • More Than a Program for Integrating Control and MES (Case Study)
  • Six Sigma: Friend or Foe (Case Study)
  • Operational Excellence Strategic Initiatives (Case Study)

Note:

Session 301 speaker Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, and Sirine A. Saleem recently authored the July/August 2008 Pharmaceutical Engineering article, Integrating Industrial Engineering and Lean Techniques at a Contract Pharmaceutical Manufacturer.

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