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Agenda

Hands-on Training for Sterile and Non-Sterile Manufacturing Excellence

June 11-13, 2019
  • Baltimore, MD

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, JUNE 11, 2019

7:30

Pre-Conference Workshop Registration and Welcome Refreshments

8:00

Pre-Conference Workshop Commences

PRE-CONFERENCE WORKSHOP Annex 1 Readiness:
Developing a Lifecycle Model for a Contamination Control Strategy Using the P-D-C-A Approach

The Annex 1 “Manufacture of Sterile Medicinal Products” has been continually updated since its release in 1971. Since then, amendments and updates have struggled to keep pace with industry best practices, as a result a complete revision has been issued. This revised guidance incorporates current principles such as Quality Risk Management, Aseptic Process Stimulation, new technologies and standardized innovative processes. Join your peers, colleagues and industry experts to discuss how the revision of Annex 1 will affect your manufacturing operations.

I. Strengths of Annex 1

II. Weaknesses of Annex 1

III. Contamination Control Strategy

Workshop Leader:

Karen Ginsbury, BPharm, MSc, MRPharmS
President and CE
PCI Pharmaceutical Consulting Israel Ltd.

There will be a 30-minute networking and refreshment break at 10:30

12:30

Main Conference Registration

1:45

Chairman’s Welcome and Opening Remarks

Zuowu Yao, PhD
Director of Quality, Head of Contamination Control
Sanofi US

2:00

Gain Insight on 2019 Trends — What is New in Microbiology?

Jeanne Moldenhauer
Vice President
Excellent Pharma Consulting

3:00

Networking and Refreshment Break

3:30

Assess the Trending of Environmental Monitoring Data Based on FDA’s Data Integrity and Compliance with cGMP Draft Guidance

Cheryl Zaman-Zadeh/Famili
Director
Novatek

Paula Peacos, MS
Senior Consultant
ValSource, Inc.

4:30

Use of Air Flow Visualization Studies to Set Up Risk Based Monitoring Sites —
Per Annex-1 Revision

Morgan Polen
Cleanroom and Contamination Control Expert
Microrite, Inc.

5:30

Close of Day One

Join Us for a
Networking Wine & Cheese Reception
at the Close of Day One

DAY TWO WEDNESDAY, JUNE 12, 2019

8:30

Continental Breakfast

8:45

Chairman’s Review of Day One

Zuowu Yao, PhD
Director of Quality, Head of Contamination Control
Sanofi US

9:00

Rapid and Alternative Testing Methods —
When and Why to Implement in the Modern Lab

Erin Patton, MS
Senior Product Specialist
Charles River Laboratories

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN TWO EDUCATIONAL TRACKS (A-B)

A. STERILE Environmental Action Committee (EAC) as a Model to Adopt for Contamination Control in Sterile Biopharmaceutical Manufacturing

I. Introduction of Environmental Action Committee

II. What EAC Does?

III. Interactive Exercise

Zuowu Yao, PhD
Director of Quality,
Head of Contamination Control
Sanofi US

 
B. NON-STERILE Burkholderia Cepacia Complex (BCC) Testing for Non-Sterile Water Based Drug Products is Coming — Get Ahead of the Game

I. Overview of Burkholderia cepacia complex (BCC) testing

II. Testing for Absence of B. Cepacia Complex (BCC)

III. FDA Guidance — What You Need to Know Regarding Prevention and Detection of BCC Microorganisms

IV. Interactive Case Study

Holly Deitrick
Senior Microbiologist/Group Leader II
Eurofins Lancaster Laboratories Inc.

12:30

Networking Luncheon

1:30

Bring Your Own Challenge

During this unique session, attendees share their greatest pain points and collaborate with counterparts to develop strategies for managing their most pressing challenges. The content for the session is driven by participants who are surveyed ahead of time about topics they wish to discuss.

2:15

Streamline Microbial Method Validations through Dynamic Templated Workflows

Kim Bowers
Global Microbiology Lead
Takeda Pharmaceutical Company Limited

3:00

Networking and Refreshment Break

3:30

Extended Session on FDA Compliance FDA Inspection Readiness —
Understand 483s Related to Pharmaceutical Microbiology

Ziva Abraham
CEO and Principal Microbiology Consultant
Microrite, Inc.

5:00

Close of Day Two

DAY THREE THURSDAY, JUNE 13, 2019

8:00

Continental Breakfast

8:30

CHOOSE BETWEEN TWO EDUCATIONAL TRACKS (C-D)

C. STERILE Contaminations– Innovative Contamination Elimination and Prevention Technologies for Sterile Manufacturing

I. Bacteria, Mold, Virus and Endotoxin Issues

II. Ozonated Water Explained

III. Chemical Warfare — Complicated, Caustic and Temporary

Brian Hubka
CEO
Contamination Prevention Technologies, Inc.

 
D. NON-STERILE The Harmonized
Microbial Limits Tested

I. Understand the History of the Harmonized Microbial Limits Test

II. Explore the Capabilities of the Harmonized Microbial Limit Test

III. Learn How the Harmonized Microbial Limit Test Is Performed

Clyde Schultz, PhD
Department of Biology
University of Calgary

10:00

Networking and Refreshment Break

10:30

Automation of Microbiological Operations — A Big Data Approach to Integration of Rapid Methods, Automated Data Collection and Analysis to the Micro Laboratory

Karen Ginsbury, BPharm, MSc, MRPharmS
President and CE
PCI Pharmaceutical Consulting Israel Ltd.

12:00

Networking Luncheon

1:00

Analytical Method Validation for the Microbiology Lab

Laurie Boyd, MBA, AT
Senior Microbiologist IV
Alkermes, Inc.

2:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, JUNE 11, 2019

7:30

Pre-Conference Workshop Registration and Welcome Refreshments

8:00

Pre-Conference Workshop Commences

PRE-CONFERENCE WORKSHOP Annex 1 Readiness:
Developing a Lifecycle Model for a Contamination Control Strategy Using the P-D-C-A Approach

The Annex 1 “Manufacture of Sterile Medicinal Products” has been continually updated since its release in 1971. Since then, amendments and updates have struggled to keep pace with industry best practices, as a result a complete revision has been issued. This revised guidance incorporates current principles such as Quality Risk Management, Aseptic Process Stimulation, new technologies and standardized innovative processes. Join your peers, colleagues and industry experts to discuss how the revision of Annex 1 will affect your manufacturing operations.

I. Strengths of Annex 1

II. Weaknesses of Annex 1

III. Contamination Control Strategy

Workshop Leader:

Karen Ginsbury, BPharm, MSc, MRPharmS
President and CE
PCI Pharmaceutical Consulting Israel Ltd.

There will be a 30-minute networking and refreshment break at 10:30

12:30

Main Conference Registration

1:45

Chairman’s Welcome and Opening Remarks

Zuowu Yao, PhD
Director of Quality, Head of Contamination Control
Sanofi US

2:00

Gain Insight on 2019 Trends — What is New in Microbiology?

Jeanne Moldenhauer
Vice President
Excellent Pharma Consulting

3:00

Networking and Refreshment Break

3:30

Assess the Trending of Environmental Monitoring Data Based on FDA’s Data Integrity and Compliance with cGMP Draft Guidance

Cheryl Zaman-Zadeh/Famili
Director
Novatek

Paula Peacos, MS
Senior Consultant
ValSource, Inc.

4:30

Use of Air Flow Visualization Studies to Set Up Risk Based Monitoring Sites —
Per Annex-1 Revision

Morgan Polen
Cleanroom and Contamination Control Expert
Microrite, Inc.

5:30

Close of Day One

Join Us for a
Networking Wine & Cheese Reception
at the Close of Day One

DAY TWO WEDNESDAY, JUNE 12, 2019

8:30

Continental Breakfast

8:45

Chairman’s Review of Day One

Zuowu Yao, PhD
Director of Quality, Head of Contamination Control
Sanofi US

9:00

Rapid and Alternative Testing Methods —
When and Why to Implement in the Modern Lab

Erin Patton, MS
Senior Product Specialist
Charles River Laboratories

10:30

Networking and Refreshment Break

11:00

CHOOSE BETWEEN TWO EDUCATIONAL TRACKS (A-B)

A. STERILE Environmental Action Committee (EAC) as a Model to Adopt for Contamination Control in Sterile Biopharmaceutical Manufacturing

I. Introduction of Environmental Action Committee

II. What EAC Does?

III. Interactive Exercise

Zuowu Yao, PhD
Director of Quality,
Head of Contamination Control
Sanofi US

 
B. NON-STERILE Burkholderia Cepacia Complex (BCC) Testing for Non-Sterile Water Based Drug Products is Coming — Get Ahead of the Game

I. Overview of Burkholderia cepacia complex (BCC) testing

II. Testing for Absence of B. Cepacia Complex (BCC)

III. FDA Guidance — What You Need to Know Regarding Prevention and Detection of BCC Microorganisms

IV. Interactive Case Study

Holly Deitrick
Senior Microbiologist/Group Leader II
Eurofins Lancaster Laboratories Inc.

12:30

Networking Luncheon

1:30

Bring Your Own Challenge

During this unique session, attendees share their greatest pain points and collaborate with counterparts to develop strategies for managing their most pressing challenges. The content for the session is driven by participants who are surveyed ahead of time about topics they wish to discuss.

2:15

Streamline Microbial Method Validations through Dynamic Templated Workflows

Kim Bowers
Global Microbiology Lead
Takeda Pharmaceutical Company Limited

3:00

Networking and Refreshment Break

3:30

Extended Session on FDA Compliance FDA Inspection Readiness —
Understand 483s Related to Pharmaceutical Microbiology

Ziva Abraham
CEO and Principal Microbiology Consultant
Microrite, Inc.

5:00

Close of Day Two

DAY THREE THURSDAY, JUNE 13, 2019

8:00

Continental Breakfast

8:30

CHOOSE BETWEEN TWO EDUCATIONAL TRACKS (C-D)

C. STERILE Contaminations– Innovative Contamination Elimination and Prevention Technologies for Sterile Manufacturing

I. Bacteria, Mold, Virus and Endotoxin Issues

II. Ozonated Water Explained

III. Chemical Warfare — Complicated, Caustic and Temporary

Brian Hubka
CEO
Contamination Prevention Technologies, Inc.

 
D. NON-STERILE The Harmonized
Microbial Limits Tested

I. Understand the History of the Harmonized Microbial Limits Test

II. Explore the Capabilities of the Harmonized Microbial Limit Test

III. Learn How the Harmonized Microbial Limit Test Is Performed

Clyde Schultz, PhD
Department of Biology
University of Calgary

10:00

Networking and Refreshment Break

10:30

Automation of Microbiological Operations — A Big Data Approach to Integration of Rapid Methods, Automated Data Collection and Analysis to the Micro Laboratory

Karen Ginsbury, BPharm, MSc, MRPharmS
President and CE
PCI Pharmaceutical Consulting Israel Ltd.

12:00

Networking Luncheon

1:00

Analytical Method Validation for the Microbiology Lab

Laurie Boyd, MBA, AT
Senior Microbiologist IV
Alkermes, Inc.

2:30

Close of Conference