Library / Resources

Three Must See Life Sciences Industry Events at Emerson Exchange 2012!

Chris Amstutz — Wed, 12 Sep 2012 13:02:57 GMT

Monday, October 8, 1:00-2:30 pm Industry Forum

Industry experts from R&D, Manufacturing, Quality, and Information Technology will participate in a roundtable discussion on “Process Robustness—from Molecules to Medicine.” The group will focus on technology transfer and continual process verification challenges, as well as how new technology will revolutionize the industry and help manufacturers achieve significant cost savings. Bring questions for the panel and join the discussion.

Panelists:
Ian Allan, Global Head of Automation and MES, Novartis Vaccines and Diagnostics
Lars Petersen, Director, Genentech/Roche
Francis Sidnam, IT Director – Biologics Manufacturing & Process Development, Bristol -Meyers Squibb
Scott Broadley, President, Broadley-James

IF User Chairman:	Lucinda Weaver
IF Emerson Chairman:	Saroj Patnaik

Monday-Wednesday, 4:00-8:00p.m. Technoloigy Exhibits

The technology exhibits are a great opportunity to get a first-hand look at some of the industry’s most innovative automation technologies, products, and services and learn more about what they can do for you. Come by the Life Sciences “Real-Time Release” booth to see the Process Analytical Technology (PAT) run-time application demonstrated on a formulation tank. By using synTQ integrated into a Syncade workflow, you can gain real-time determination of critical quality attributes and process control. Experts will be on hand to answer any questions you might have.

Tuesday, 8:00p.m. California A - Bristol-Myers Squibb Manufacturing for the 21st Century

The Emerson Life Sciences team will host a special presentation, Bristol-Myers Squibb Manufacturing for the 21st Century, for all Life Sciences attendees on Tuesday evening after the Technology Exhibit closes. Cocktails and a light dinner will be served. Bristol-Myers Squibb (BMS) will share details on their successful start-up at their green field biologics plant in Devens, MA—from their original vision for the project to receiving FDA preapproval to manufacture. The BMS plant is using Syncade to go totally paperless and DeltaV digital automation system to automate all manufacturing processes. Their automation system is also heavily integrated with enterprise and plant-level systems including SAP, LIMS, Scheduling, CMMS, OSI PI, and off-line instruments. Please contact your local Emerson representative to attend.

DCA Coverpage Creation

Gary Macri — Mon, 27 Aug 2012 11:42:55 GMT

When deciding what to put on your documents cover pages it's always important to first identify the dynamic data that can be added to the coverpage. Like any project the best work comes when you do a lot of upfront work. I have attached a tool/doc to help you identify which fields are dynamic and can be included on the cover page.

I generally always use the following fields:

VERSIONNUMBER
STATUS
NAME
DESCRIPTION
EFFECTIVEDATEIN
DocType
RoleCRApprover

Like always have fun..

I LOVE THIS STUFF,

~Gary Macri

Emerson Exchange 2012 _ Life Sciences Technical Presentations

Chris Amstutz — Tue, 07 Aug 2012 13:46:25 GMT

FDA - Q8, Q9, & Q10 Questions and Answers

Chris Amstutz — Fri, 03 Aug 2012 12:20:46 GMT

FDA Industry Working Group document that provides clarifiication on the ICH guidelines as it relates to cGMP regulations. Also avaiable on the FDA.gov website.

Pharmaceutical Manufacturing in China - CMO Market Outlook

Chris Amstutz — Wed, 01 Aug 2012 10:53:42 GMT

Infographic for the chinese CMO market compiled by www.pharmamanufacturingchina.com.

Life Science Industry Panel

Chris Amstutz — Wed, 30 May 2012 13:44:20 GMT

Very good Life Science industry panel on industry challenges. From left to right, Peter Zornio - Emerson, Peter Iles-Smith - GSK, Leif Poulsen - NNE, and Ian M. Allen - Novartis. Thanks for the contribution and insights and the the audience participation.

White Paper - Making Technology Transfer Painless

Chris Amstutz — Thu, 02 Feb 2012 12:46:58 GMT

Solutions booth headed to Exchange Europe

Chris Amstutz — Mon, 09 Jan 2012 14:23:36 GMT

The real time solutions booth that demos Syncade recipes with embedded PAT methods is headed to Exchange Europe!