|
|
|
Downloads, Webinars
SAP-Based MES in Regulatory Industries: Purdue Pharma Case Study
presented by Chuck Nardi (Purdue Pharma) and Mike DePriest (EnteGreat) on Wednesday, April 21, 2004 at 11AM EST.
Request a CD copy of this Webinar - please click here.
Presentation Overview:
More and more industries are finding themselves subject to regulatory oversight. Projects that were once justified on ROI alone must now also demonstrate how they support compliance in all aspects of operations, including manufacturing. As a result, manufacturers are looking to limit their validation exposure and taking another look at SAP's ability to support compliant manufacturing.
Chuck Nardi and Mike DePriest describe Purdue Pharma's recent project, which drives SAP to the shop-floor, to enable a production flow that's accurate, responsive, and compliant.
| Presentation Outline: |
| Project Background |
- Situation Overview
- Purdue’s key compliance requirements
- Organizing requirements into a compliant manufacturing model
|
Purdue Compliant Manufacturing Program Strategy |
- Purdue’s Compliant Manufacturing Program Strategy
- Using S88 for manufacturing modeling
- Defining the overall manufacturing systems architecture
- Shop floor connectivity using OPC
- Manufacturing integration best practices
|
Enforced Compliance Using SAP Manufacturing |
- Process Management, PI Sheets and EBRs
- Compliant manufacturing functions in a nutshell
- Purdue compliance steps (1-8)
- Qualifications Management
- Qualifications management process pre-implementation
- Qualifications management handling post-implementation
- Qualification compliance reporting
- Electronic Cleaning, Maintenance, and Use Logbooks
- Automatic setting of equipment status
- Interlock with process and maintenance workflow
- Quality Events Management & CAPA
- Implementation scope
- Enforced compliance when manufacturing event occurs
- GNOE examples
|
| Question and Answer Session |
About the Presenters
Chuck Nardi, Executive Director of Corporate and Supply Chain Systems for Purdue Pharma, is responsible for all of SAP, Manufacturing, and Finance Systems, as well as IT applications support for all Corporate Systems. Chuck joined Purdue in 2000 as their SAP Program Director and was charged with directing and leading the successful implementation of SAP ERP across Purdue. Since the initial go-live, Chuck has led successful projects at Purdue in the areas of: Strategic Enterprise Management and Business Warehouse, Supplier Relationship Management, Manufacturing Execution Systems, and RFID.
Mike DePriest worked with Purdue Pharma on their recent project to drive SAP to the shop-floor, thus enabling a production flow that's accurate, responsive, and compliant. Mike's responsibilities on this project included directing EnteGreat's overall project execution methodology as well as defining the manufacturing process and equipment models (using S.88), data requirements analysis, review of standard operating procedures and batch record information, manufacturing process best practices and synchronization, quality assurance during blueprinting/design and implementation, change management for deployment of the manufacturing solution, and definition of prototypes for end-user adoption of the solution. Mike is a principle consultant with EnteGreat and has more than 15 years of experience working with the entire range of systems technologies and methodologies employed in manufacturing, from control systems to ERP, including MES, LIMS, Maintenance Management and Quality Management.
Request a CD copy of this Webinar - please click here.
|
