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Agenda

Beyond Theory — Drive the Facility of the Future Utilizing MES and Continuous Manufacturing

August 15-16, 2017
  • Orlando, FL

Agenda

Want more agenda details? Download the brochure.

DAY ONE Tuesday, August 15, 2017

7:45

Conference Registration and Continental Breakfast

8:45

Chairperson’s Welcome and Opening Remarks

Earlene Gibbons, PMP
Senior Director, Operational Technology
United Therapeutics

9:00

EYE-OPENING KEYNOTE Life Sciences Manufacturing Vision of the Future —
Personalized Medicine, Smart Manufacturing and IoT

Daniel Matlis
President
Axendia

10:00

A PIONEER’S PERSPECTIVE Leverage Continuous Manufacturing for High Quality and Streamlined Production

Todd Lybrook, PMP
MES Portfolio Director US
Siemens Industry Inc.

Pam Docherty
Life Sciences Industry Manager
Siemens Industry Inc.

10:45

NETWORKING AND REFRESHMENT BREAK SYSTEM-SOLUTION EXCHANGE

11:15

EXTENDED REGULATORY SPOTLIGHT Data Integrity Deep-Dive —
Uncover Hidden Compliance Risks within New Technologies and Software Systems

I. What Is data integrity?

II. What Is the AAA model for information security?

III. How do we ensure the integrity of our electronic data in validated computerized systems?

Raul Soto
Principal Engineer
Johnson & Johnson Vision

12:15

Networking Luncheon

Track and Trek — Efficiency and ROI Every Step of the Way During these tailored breakouts, move between sessions based on where you are within the lifecycle of your MES journey. This content is designed to accelerate MES adoption and advance the application of software and integration capabilities.

EARLY STAGES OF MES

1:30

Cost/ROI Strategies —
Illustrate the Concrete Value of MES and Calculate Costs Saved Due to Deployment

I. Approaches to Fully Recognize the ROI of MES

II. Cost Management and Effectiveness Analysis

III. Select the Right Vendor for your Operations

Denny Catacora
Senior Engineer, Manufacturing Execution Sysstems
CSL Behring

3:00

Networking and Refreshment Break

3:30

MES Roadmap for Successful Implementation and Roll-Out

Earlene Gibbons, PMP
Senior Director, Operational Technology
United Therapeutics

 
ADVANCED APPLICATION OF MES

1:30

Validation of Manufacturing Execution Systems (MES)

MES are key systems in modern manufacturing. They permit the integration of automation control elements (PLCs, HMI / SCADA systems) with systems such as ERP, LIMS and distribution control systems, among others. This workshop examines an advanced SDLC approach to validating MES systems based on practical, real-life experience.

I. A Systems Development Lifecycle Approach to MES Validation

II. Validation and Project Deliverables

III. Going Live

Raul Soto
Principal Engineer
Johnson & Johnson Vision

3:00

Networking and Refreshment Break

3:30

ELITE EXCHANGE Trailblazer Talk —
The Journey to the Facility of the Future

FACILITATOR:

Mehron Mirian
Senior Manager, QA Validation
Avid Bioservices, Inc.

5:00

MES MARKETPLACE AND INNOVATIONS LAB During this portion of the meeting, enjoy wine and cheese while networking with industry colleagues and leading business partners. Continue the conversation after a content-rich day and benefit from one-on-one discussions and live demos with your peers who are driving the MES system of the future.

DAY TWO Wednesday, August 16, 2017

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Earlene Gibbons, PMP
Senior Director, Operational Technology
United Therapeutics

8:45

MES AUDIT DEEP DIVE Computerized System Audit — What Are the Considerations for MES?

It is expected that life science industry’s reliance on computerized systems will continue to grow, rather than diminish. In recent years there has been an increasing trend to integrate electronic record and business management systems across all operational areas. In lieu of that, the use of validated and effective GxP controlled computerized systems should provide enhancements in the quality assurance management of regulated materials/ products and associated data/information management. To achieve a successful quality assurance management and to determine the level of compliance, audit is a key system tool. Specific to computerized systems, audit ensures that these systems comply with applicable regulatory standards.

I. What does an Audit mean to Life Science Industries?

II. What Are references for Computerized Systems Audit?

III. What Are the Agency Audit Considerations for a Computerized System? MES?

IV. What Does the “Survey” Say?

Mehron Mirian
Senior Manager, QA Validation
Avid Bioservices, Inc.

9:45

Established A Models for Deploying in a Global Environment

Casey Fox
Software Engineer, Operations Applications
Amway

10:45

NETWORKING AND REFRESHMENT BREAK SYSTEM-SOLUTION EXCHANGE

11:15

External Parameters from ERP and How They Enrich the Business Value of Integration between ERP and MES

Rachit Jain
Manager, Consulting
Werum IT Solutions America, Inc.

12:15

Networking Luncheon

1:15

Integrating with Other Enterprise Systems, Equipment and Controllers to Produce a Flexible and Agile MES System

Daniel Trivino
Senior MES Engineer
CSL Behring

2:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE Tuesday, August 15, 2017

7:45

Conference Registration and Continental Breakfast

8:45

Chairperson’s Welcome and Opening Remarks

Earlene Gibbons, PMP
Senior Director, Operational Technology
United Therapeutics

9:00

EYE-OPENING KEYNOTE Life Sciences Manufacturing Vision of the Future —
Personalized Medicine, Smart Manufacturing and IoT

Daniel Matlis
President
Axendia

10:00

A PIONEER’S PERSPECTIVE Leverage Continuous Manufacturing for High Quality and Streamlined Production

Todd Lybrook, PMP
MES Portfolio Director US
Siemens Industry Inc.

Pam Docherty
Life Sciences Industry Manager
Siemens Industry Inc.

10:45

NETWORKING AND REFRESHMENT BREAK SYSTEM-SOLUTION EXCHANGE

11:15

EXTENDED REGULATORY SPOTLIGHT Data Integrity Deep-Dive —
Uncover Hidden Compliance Risks within New Technologies and Software Systems

I. What Is data integrity?

II. What Is the AAA model for information security?

III. How do we ensure the integrity of our electronic data in validated computerized systems?

Raul Soto
Principal Engineer
Johnson & Johnson Vision

12:15

Networking Luncheon

Track and Trek — Efficiency and ROI Every Step of the Way During these tailored breakouts, move between sessions based on where you are within the lifecycle of your MES journey. This content is designed to accelerate MES adoption and advance the application of software and integration capabilities.

EARLY STAGES OF MES

1:30

Cost/ROI Strategies —
Illustrate the Concrete Value of MES and Calculate Costs Saved Due to Deployment

I. Approaches to Fully Recognize the ROI of MES

II. Cost Management and Effectiveness Analysis

III. Select the Right Vendor for your Operations

Denny Catacora
Senior Engineer, Manufacturing Execution Sysstems
CSL Behring

3:00

Networking and Refreshment Break

3:30

MES Roadmap for Successful Implementation and Roll-Out

Earlene Gibbons, PMP
Senior Director, Operational Technology
United Therapeutics

 
ADVANCED APPLICATION OF MES

1:30

Validation of Manufacturing Execution Systems (MES)

MES are key systems in modern manufacturing. They permit the integration of automation control elements (PLCs, HMI / SCADA systems) with systems such as ERP, LIMS and distribution control systems, among others. This workshop examines an advanced SDLC approach to validating MES systems based on practical, real-life experience.

I. A Systems Development Lifecycle Approach to MES Validation

II. Validation and Project Deliverables

III. Going Live

Raul Soto
Principal Engineer
Johnson & Johnson Vision

3:00

Networking and Refreshment Break

3:30

ELITE EXCHANGE Trailblazer Talk —
The Journey to the Facility of the Future

FACILITATOR:

Mehron Mirian
Senior Manager, QA Validation
Avid Bioservices, Inc.

5:00

MES MARKETPLACE AND INNOVATIONS LAB During this portion of the meeting, enjoy wine and cheese while networking with industry colleagues and leading business partners. Continue the conversation after a content-rich day and benefit from one-on-one discussions and live demos with your peers who are driving the MES system of the future.

DAY TWO Wednesday, August 16, 2017

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Earlene Gibbons, PMP
Senior Director, Operational Technology
United Therapeutics

8:45

MES AUDIT DEEP DIVE Computerized System Audit — What Are the Considerations for MES?

It is expected that life science industry’s reliance on computerized systems will continue to grow, rather than diminish. In recent years there has been an increasing trend to integrate electronic record and business management systems across all operational areas. In lieu of that, the use of validated and effective GxP controlled computerized systems should provide enhancements in the quality assurance management of regulated materials/ products and associated data/information management. To achieve a successful quality assurance management and to determine the level of compliance, audit is a key system tool. Specific to computerized systems, audit ensures that these systems comply with applicable regulatory standards.

I. What does an Audit mean to Life Science Industries?

II. What Are references for Computerized Systems Audit?

III. What Are the Agency Audit Considerations for a Computerized System? MES?

IV. What Does the “Survey” Say?

Mehron Mirian
Senior Manager, QA Validation
Avid Bioservices, Inc.

9:45

Established A Models for Deploying in a Global Environment

Casey Fox
Software Engineer, Operations Applications
Amway

10:45

NETWORKING AND REFRESHMENT BREAK SYSTEM-SOLUTION EXCHANGE

11:15

External Parameters from ERP and How They Enrich the Business Value of Integration between ERP and MES

Rachit Jain
Manager, Consulting
Werum IT Solutions America, Inc.

12:15

Networking Luncheon

1:15

Integrating with Other Enterprise Systems, Equipment and Controllers to Produce a Flexible and Agile MES System

Daniel Trivino
Senior MES Engineer
CSL Behring

2:15

Close of Conference