On May 8th, 2014, the ISPE Los Angeles Chapter’s 21st annual vendor night exhibit show with complimentary technical seminars was held, and this year’s theme was Cinco de Mayo!
The first session, lead by speaker Larry Doris, Director, Operational Excellence/ Global Lean & Six Sigma Deployment, Lean Master Black Belt at Baxter Healthcare, was called “Leading Daily Improvement”.
He addressed building a visually assertive system unafraid of accountability, to drive compliance and continuous improvement. He covered understanding the implementation of leader standard work, visual controls, and accountability process to improve safety, quality, and productivity performance. He also spoke about leveraging layered standardized gemba walks to drive compliance and continuous improvement, and he illustrated the importance of engaging employees at all levels to identify and close gaps.
The second session, lead by speaker Bikash Chatterjee, President and Chief Technology Officer at Pharmatech Associates, Inc., was titled “A Comparison of Sterile Drug Product Submissions to the US, Europe and China”.
In his presentation, he compared and contrasted the differences in terms of requirements between sterile drug submission in the US, European and Chinese marketplaces. His presentation touched upon practical path, the baseline requirements, the US FDA sterile drug guidance, the EU Annexes 1-3 and discussed the current expectations in China based upon their updated guidances issued in 2010 and 2011.
The third session, lead by Miguel Cerezo, Director, Engineering at Amgen Inc., was called “Calibration Process Management: A Strategic Approach”.
His presentation provided an overview of industry best practice calibration process management solutions that are tailored towards optimizing compliance while reducing costs and providing a competitive advantage. Several examples of innovative calibration process improvements were described.
Thank you to our exhibitors for sponsoring the three complimentary technical sessions.
The exhibitors at the event included:
– Hamo USA
– ISA LA