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Agenda

Adopt and Implement Emerging Technologies to Stay Ahead of Changing Regulations, Promote Efficiency and Reduce Costs

March 28-29, 2019
  • Chicago, IL

Agenda

Want more agenda details? Download the brochure.

DAY ONE | Thursday, March 28, 2019

7:30

Registration and Continental Breakfast

8:30

Chairman’s Opening Remarks

Mark Leuenberger
President / Principal Consultant
Profound Development Group

Master Emerging Regulations to Ensure Compliance

8:45

DEA Overview — Manufacturing and Labeling Audits and Enforcement

Stephen Buzzeo
Division Program Manager
Drug Enforcement Agency

Dan Gillen
Deputy Commander, Import Export Unit
Drug Enforcement Agency

9:30

Master Global Clinical Labeling Challenges and Requirements

Andrew Blaisdell
Senior Specialist, Drug Supply Label Development
Biogen

10:15

Networking and Refreshment Break

10:45

Serialization — Implementation and Integration on a Global Scale

Hernan Gonzalez
Manager, External Supply
Pfizer Inc

11:30

Master the Size and Space Challenges Caused by Increased Content and Requirements

Gail Tennyson Hicks
Associate Program Director
Genentech

12:15

Networking Luncheon

Develop Best Practices and Align Internal Teams

1:30

Ensure Error Proof Labels with Emerging Technology and Strong SOPs

William Topaczewski
Account Executive
GlobalVision

2:15

Behind the Scenes of End-to-End (E2E) Labeling

Jackie Leslie
Business Development
Esko Brand Solutions

3:00

Networking and Refreshment Break

3:30

ROUNDTABLE
Master Error Discovery and Correction in Label Development

Keith Schlotthauer
R&D Sustaining Engineer – Label and Packaging Specialist
Stryker

4:30

Implement Global Harmonization of Artwork Processes

Arun Banerjee
Labeling Process Excellence Lead
J&J Regulatory Operations

5:15

Close of Day One

Networking, Wine and Cheese Receptionfollowing the final session, hosted by:

DAY TWO | Friday, March 29, 2019

7:30

Continental Breakfast

8:30

Chairman’s Review of Day One

Mark Leuenberger
President / Principal Consultant
Profound Development Group

Develop Reliable and Secure Tamper Evidence Measures

8:45

Reduce Costs, Timelines and Inefficiencies in Packaging Remediation

Mark Leuenberger
President / Principal Consultant
Profound Development Group

9:30

Packaging Design, Qualification and Test for Autologous Cell Therapy

Pauline Yang
Senior Packaging Engineer I
Kite Pharma

10:15

Networking and Refreshment Break

10:45

Streamline Tamper Evident Packaging Development for
Operational Efficiencies

Swanand Kullarwar
Senior Packaging Engineer
Zimmer Biomet

Streamline Development to Find Efficiencies & Consistency

11:30

ROUNDTABLE
Durable and Tamper Evident Labels — Evaluate Technologies and Strategies to Improve Product Security and Brand Protection

Mark Leuenberger
President / Principal Consultant
Profound Development Group

12:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE | Thursday, March 28, 2019

7:30

Registration and Continental Breakfast

8:30

Chairman’s Opening Remarks

Mark Leuenberger
President / Principal Consultant
Profound Development Group

Master Emerging Regulations to Ensure Compliance

8:45

DEA Overview — Manufacturing and Labeling Audits and Enforcement

Stephen Buzzeo
Division Program Manager
Drug Enforcement Agency

Dan Gillen
Deputy Commander, Import Export Unit
Drug Enforcement Agency

9:30

Master Global Clinical Labeling Challenges and Requirements

Andrew Blaisdell
Senior Specialist, Drug Supply Label Development
Biogen

10:15

Networking and Refreshment Break

10:45

Serialization — Implementation and Integration on a Global Scale

Hernan Gonzalez
Manager, External Supply
Pfizer Inc

11:30

Master the Size and Space Challenges Caused by Increased Content and Requirements

Gail Tennyson Hicks
Associate Program Director
Genentech

12:15

Networking Luncheon

Develop Best Practices and Align Internal Teams

1:30

Ensure Error Proof Labels with Emerging Technology and Strong SOPs

William Topaczewski
Account Executive
GlobalVision

2:15

Behind the Scenes of End-to-End (E2E) Labeling

Jackie Leslie
Business Development
Esko Brand Solutions

3:00

Networking and Refreshment Break

3:30

ROUNDTABLE
Master Error Discovery and Correction in Label Development

Keith Schlotthauer
R&D Sustaining Engineer – Label and Packaging Specialist
Stryker

4:30

Implement Global Harmonization of Artwork Processes

Arun Banerjee
Labeling Process Excellence Lead
J&J Regulatory Operations

5:15

Close of Day One

Networking, Wine and Cheese Receptionfollowing the final session, hosted by:

DAY TWO | Friday, March 29, 2019

7:30

Continental Breakfast

8:30

Chairman’s Review of Day One

Mark Leuenberger
President / Principal Consultant
Profound Development Group

Develop Reliable and Secure Tamper Evidence Measures

8:45

Reduce Costs, Timelines and Inefficiencies in Packaging Remediation

Mark Leuenberger
President / Principal Consultant
Profound Development Group

9:30

Packaging Design, Qualification and Test for Autologous Cell Therapy

Pauline Yang
Senior Packaging Engineer I
Kite Pharma

10:15

Networking and Refreshment Break

10:45

Streamline Tamper Evident Packaging Development for
Operational Efficiencies

Swanand Kullarwar
Senior Packaging Engineer
Zimmer Biomet

Streamline Development to Find Efficiencies & Consistency

11:30

ROUNDTABLE
Durable and Tamper Evident Labels — Evaluate Technologies and Strategies to Improve Product Security and Brand Protection

Mark Leuenberger
President / Principal Consultant
Profound Development Group

12:30

Close of Conference