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Lean Six Sigma for Robust Process Development

Presenter: Barry Gujral, Director, Patheon, Inc., Durham, NC, USA

Co-Presenter: Jonathan Paul Goerk, Real Time Release Process Engineer, Patheon, Durham, NC, USA

Keywords: QbD, Process, Pharmaceutical

Industry: Food/Drug/Cosmetics, Healthcare, Manufacturing

Level: Intermediate


ABSTRACT

Traditionally Lean Six Sigma is used as a structured problem-solving methodology which leads teams through a logical problem-solving approach. With six sigma, a problem with an unknown solution is analyzed though the DMAIC process to achieve higher levels of process understanding, ultimately allowing the implementation of longstanding corrective actions which improve the process control and end product quality. In addition to serving as a reactive problem-solving approach, the tools of Lean Six Sigma can be used proactively to develop robust pharmaceutical processes. The process is robust as it will be capable of consistently producing final product within specifications, by maintaining inputs within the known control limits of the critical input factors. The tools used for developing robust processes with six sigma include Design for Six Sigma, process understanding, statistical control, and design of experiments. Through the use of six sigma tools, it is possible to ultimately reach the same goals as those achieved through the use of the Quality by Design methodology.


Call for Proposals

Proposal Submission Deadline:
October 11, 2019

Acceptance notification date:
November 11, 2019

Early Registration Deadline:
February 11, 2020

Please make sure to review and prepare the material needed before you start the on-line Proposal Submission Form. Click here to see Proposal Submission Guidelines.

Who May Submit: This online form may be used by a principal speaker, co-speaker, contact person, or a committee member submitting on behalf of a speaker.

Multiple Proposals: You may submit multiple proposals.

Conference Registration Fee:
The conference registration fee is waived for the principal speaker of accepted proposals. Speakers are responsible for their travel expenses and arrangements. Co-speakers will receive a 30% discount for the conference that they are presenting at.

Length of Presentations: Technical sessions are typically 35 minutes. There will be a limited number of "double" sessions, 70 minutes, at the end of each day.

You will need the following to submit a proposal

Proposal Title: Maximum 80 characters including spaces. 

Keywords:Please include three keywords with a maximum of 100 characters, including spaces. 

Industry Sector: Please select the most relevant Industry sector for the proposal from a list.

Abstract: The Abstract should be 1,500 to 5,000 characters (note that it is Characters, NOT words), including spaces.

Biography: The Biography must be 1,500 to 5,000 characters, including spaces.

Public Profile: LinkedIn or Public Profile for link for the Principal Speaker: 

Speaker's Photo (optional)

Sample Video (optional)

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