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Agenda

Establish, Manage and Maintain Cleaning Validation Processes in Compliance with cGMPs

August 21-23, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, AUGUST 21, 2018

7:30

Workshop Registration and Continental Breakfast

8:30

Workshop Leader’s Opening Remarks

PRE-CONFERENCE WORKSHOP Develop a Risk Mitigation Strategy for Lifecycle Management of a Shared Facility Come away with an inspection package on cleaning management

I. Regulations, Requirements, Guidelines and Standards

II. Risk Mitigation Strategy

III. FMEA

IV. Interactive Exercise

Workshop Leader:

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

There will be a 30-minute networking and refreshment break at 10:00am

12:00

Main Conference Registration and Networking Luncheon

1:00

Chairperson’s Welcome and Opening Remarks

Jenna Carlson
Director, Quality Assurance
Coherus Biosciences

1:15

Lifecycle Approach to Cleaning Validation

I. Outline, Definitions and Objectives

II. Lifecycle Approach to Process Validation

III. Lifecycle Approach to Cleaning Validation

IV. Cleaning Validation Stage 1 — Process Development

V. Cleaning Validation Stage 2 — Process Demonstration

VI. Cleaning Validation Stage 3 — Monitoring and Maintenance

VII. Supportive Topics — Equipment and Analytical

VIII. Interactive Discussion

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and
Journal of GXP Compliance, IVT/CBI/UBM;
Associate Professor, Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

2:45

Networking and Refreshment Break

3:15

Regulatory Pulse — Emerging Regulations and Enforcement Trends in Cleaning and Mitigation of Cross Contamination

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

4:00

Cleaning Inspection Readiness — Are You Prepared?

Jenna Carlson
Director, Quality Assurance
Coherus Biosciences

4:45

Design an Effective Cleaning Process

Beth Kroeger
Technical Services Manager
STERIS Life Sciences

5:30

Close of Day One

Networking, Wine and Cheese Reception Office Hours — Meet one-on-one with speakers to
solve your individual cleaning validation challenges
Hosted by:

DAY TWO WEDNESDAY, AUGUST 22, 2018

7:30

Continental Breakfast

7:45

Cleaning Demonstrations

Attendees have the opportunity to participate in cleaning validation and critical cleaning processes. A variety of cleaning demonstrations occur during breakfast.

8:30

Chairperson’s Review of Day One

Jenna Carlson
Director, Quality Assurance
Coherus Biosciences

8:45

Targeted Cleaning for the Pharma Industry

Chad Rhodes
Business Development Manager
Dober

9:30

Cleaning Validation Documents Overview and Applications

I. Stage 1 Cleaning Validation Documents

II. Stage 2 and Stage 3 Cleaning Validation Documents

III. Interactive Knowledge Exchange

IV. Tools

Fred Ohsiek
Senior Manager, Cleaning Validation
Bayer Berkeley

11:00

Networking and Refreshment Break; Office Hours
Meet one-on-one with speakers to solve your individual cleaning validation challenges

11:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

Session 1 Introduction to Validation Statistics for
Non-Statisticians

I. Introduction

II. The Concept of Variance and Why It Is Important

III. Expressing Variance

IV. Process Capability

V. Acceptance Sampling for Validation

VI. Conclusion and Discussion

Alan Golden
Principal, Design Quality Consultants, LLC;
Retired, Abbott Molecular

Session 2 Senior-Level Think Tank —
Can Cross-Contamination be Prevented?

In this session, the participants determine the topics and the direction.

The think tank has become a much-loved feature of IVT’s conferences. Intended for professionals with a minimum of 10 years hands-on experience in the pharmaceutical/biopharma industry, it frequently attracts experts who have been working in the field for 30+ years! It is the ultimate interactive, fun, therapy and benchmarking opportunity. Mark your conference schedule and be sure to let us know so that we send you the pre-session survey to fill out.

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

1:00

Networking Luncheon

2:00

Global Problems in Cleaning and Cleaning Validation

I. Outline, Definitions and Objectives

II. Product Problems

III. Equipment-Related Problems

IV. Cleaning Process Problems

V. Laboratory Problems

VI. Management and Staff

VII. Self-Audit Questions

VIII. Interactive Discussion

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and
Journal of GXP Compliance, IVT/CBI/UBM;
Associate Professor, Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

3:00

Networking and Refreshment Break

3:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (3-4)

Session 3 Cleaning Validation Considerations for
Multi-Product Transfer to Consolidated Manufacturing Facility

I. Design of a Cleaning Validation Relocation Plan for a Multi-Product Facility

II. How to Create a Routine Monitoring Program

III. Manual Cleaning Validation Approach

IV. Interactive Activity

Alejandro Miranda, MS
Senior Validation Engineer
Grifols Diagnostics Solutions

Session 4 User Requirements and Implementation of a Risk Based, Compliant Cleaning Validation Management System Based on the Draft Guidance on Data Integrity

In pharmaceutical manufacturing, risk of contamination is caused from a broad range of factors such as cross contamination (other pharmaceutical active ingredients), cleaning agents and micro-organisms.

Additionally, the risk of contamination may in some cases be from a calculation error which results in choosing the wrong Maximum Carry-Over Limit (MAC). For example, can you consider the number of calculations required for an equipment train, with twenty (20) sample points, having different surface areas (swab sample area), different sampling types (swab/rinse), five (5) products manufactured on the equipment train, and each product has ten (10) production stages, and two (2) different cleaning agents are used. There is a huge risk associate with calculating the Maximum Carry-Over Limit (MAC) manually.

Automation has played a key role in decreasing risks associated with various processes. Data integrity is an important component of the industry’s responsibility to ensure the safety, efficacy and quality of pharmaceutical products.

Susan Cleary
Director, Product Development
Novatek International

5:00

Close of Day Two

DAY THREE THURSDAY, AUGUST 23, 2018

8:00

Continental Breakfast

8:30

INTERACTIVE SESSION Mock Cleaning Validation Inspection

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

10:00

Networking and Refreshment Break; Office Hours
Meet one-on-one with speakers to solve your individual cleaning validation challenges

10:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (5-6)

Session 5 Statistical Process Control —
Control Chart Creation and Interpretation

I. Statistical Process Control (SPC)

II. Control Charting Basics Using Microsoft Excel

Douglas Brown, PhD
Research Scientist, Methods Development and Validation, Biologics Testing Solutions
Charles River Laboratories, Inc.

Session 6 Methodology for Evaluating Protein Inactivation During Cleaning and Sterilization — Applications to Changeovers and Setting Acceptance Limits in Multi-Product Facilities

As pharmaceuticals have become more potent over the years, cleaning validation acceptance limits for APIs have declined steadily. The lower acceptance limits have led to several issues such as longer cleaning and equipment turnaround times, and lower success rates for cleaning operations. These issues have substantially increased the cost and duration of validation campaigns, and the risk of delays to new product launches. Additionally, the advent of high potency products with extended half-lives has heightened regulatory scrutiny of potential cross-contamination in multi-product facilities. Strategies for addressing these issues are presented with recent case studies.

Rizwan Sharnez, PhD
Founder and Owner, Cleaning Validation Solutions;
Former Scientific Director, Amgen

12:00

Networking Luncheon

1:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (7-8)

Session 7 Establish a Compliant
Disinfectant Efficacy Program

I. Application of the Assay

II. Develop and Perform the Method

III. Interactive Exercise

Crystal Booth, MM
Senior Director, Corporate Quality
Avista Pharma Solutions

Session 8 The Next Step in the CV Lifecycle —
Creating and Maintaining a Monitoring Program for Validated Cleaning Processes

I. Why Have a Cleaning Monitoring Program?

II. Where to Start

III. Creating Your Monitoring Program

IV. Implementation

V. Maintaining the Monitoring Program

VI. Maturing the Monitoring Program

VII. Interactive Discussion — Watch Outs and Pitfalls

Ed Rose
Staff Validation Engineer
Johnson & Johnson Consumer Inc. (Invited)

2:30

Networking and Refreshment Break

3:00

Long-Term Storage and Return to Service of Equipment

I. Understand the Difference between Normal Production and Long-Term Storage

II. Factors Affecting Long-Term Storage

III. Return to Service

IV. Interactive Discussion

Jenna Carlson
Director, Quality Assurance
Coherus Biosciences

4:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, AUGUST 21, 2018

7:30

Workshop Registration and Continental Breakfast

8:30

Workshop Leader’s Opening Remarks

PRE-CONFERENCE WORKSHOP Develop a Risk Mitigation Strategy for Lifecycle Management of a Shared Facility Come away with an inspection package on cleaning management

I. Regulations, Requirements, Guidelines and Standards

II. Risk Mitigation Strategy

III. FMEA

IV. Interactive Exercise

Workshop Leader:

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd.

There will be a 30-minute networking and refreshment break at 10:00am

12:00

Main Conference Registration and Networking Luncheon

1:00

Chairperson’s Welcome and Opening Remarks

Jenna Carlson
Director, Quality Assurance
Coherus Biosciences

1:15

Lifecycle Approach to Cleaning Validation

I. Outline, Definitions and Objectives

II. Lifecycle Approach to Process Validation

III. Lifecycle Approach to Cleaning Validation

IV. Cleaning Validation Stage 1 — Process Development

V. Cleaning Validation Stage 2 — Process Demonstration

VI. Cleaning Validation Stage 3 — Monitoring and Maintenance

VII. Supportive Topics — Equipment and Analytical

VIII. Interactive Discussion

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and
Journal of GXP Compliance, IVT/CBI/UBM;
Associate Professor, Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

2:45

Networking and Refreshment Break

3:15

Regulatory Pulse — Emerging Regulations and Enforcement Trends in Cleaning and Mitigation of Cross Contamination

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

4:00

Cleaning Inspection Readiness — Are You Prepared?

Jenna Carlson
Director, Quality Assurance
Coherus Biosciences

4:45

Design an Effective Cleaning Process

Beth Kroeger
Technical Services Manager
STERIS Life Sciences

5:30

Close of Day One

Networking, Wine and Cheese Reception Office Hours — Meet one-on-one with speakers to
solve your individual cleaning validation challenges
Hosted by:

DAY TWO WEDNESDAY, AUGUST 22, 2018

7:30

Continental Breakfast

7:45

Cleaning Demonstrations

Attendees have the opportunity to participate in cleaning validation and critical cleaning processes. A variety of cleaning demonstrations occur during breakfast.

8:30

Chairperson’s Review of Day One

Jenna Carlson
Director, Quality Assurance
Coherus Biosciences

8:45

Targeted Cleaning for the Pharma Industry

Chad Rhodes
Business Development Manager
Dober

9:30

Cleaning Validation Documents Overview and Applications

I. Stage 1 Cleaning Validation Documents

II. Stage 2 and Stage 3 Cleaning Validation Documents

III. Interactive Knowledge Exchange

IV. Tools

Fred Ohsiek
Senior Manager, Cleaning Validation
Bayer Berkeley

11:00

Networking and Refreshment Break; Office Hours
Meet one-on-one with speakers to solve your individual cleaning validation challenges

11:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (1-2)

Session 1 Introduction to Validation Statistics for
Non-Statisticians

I. Introduction

II. The Concept of Variance and Why It Is Important

III. Expressing Variance

IV. Process Capability

V. Acceptance Sampling for Validation

VI. Conclusion and Discussion

Alan Golden
Principal, Design Quality Consultants, LLC;
Retired, Abbott Molecular

Session 2 Senior-Level Think Tank —
Can Cross-Contamination be Prevented?

In this session, the participants determine the topics and the direction.

The think tank has become a much-loved feature of IVT’s conferences. Intended for professionals with a minimum of 10 years hands-on experience in the pharmaceutical/biopharma industry, it frequently attracts experts who have been working in the field for 30+ years! It is the ultimate interactive, fun, therapy and benchmarking opportunity. Mark your conference schedule and be sure to let us know so that we send you the pre-session survey to fill out.

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

1:00

Networking Luncheon

2:00

Global Problems in Cleaning and Cleaning Validation

I. Outline, Definitions and Objectives

II. Product Problems

III. Equipment-Related Problems

IV. Cleaning Process Problems

V. Laboratory Problems

VI. Management and Staff

VII. Self-Audit Questions

VIII. Interactive Discussion

Paul L. Pluta, PhD
Editor-in-Chief, Journal of Validation Technology and
Journal of GXP Compliance, IVT/CBI/UBM;
Associate Professor, Biopharmaceutics
University of Illinois at Chicago (UIC) College of Pharmacy

3:00

Networking and Refreshment Break

3:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (3-4)

Session 3 Cleaning Validation Considerations for
Multi-Product Transfer to Consolidated Manufacturing Facility

I. Design of a Cleaning Validation Relocation Plan for a Multi-Product Facility

II. How to Create a Routine Monitoring Program

III. Manual Cleaning Validation Approach

IV. Interactive Activity

Alejandro Miranda, MS
Senior Validation Engineer
Grifols Diagnostics Solutions

Session 4 User Requirements and Implementation of a Risk Based, Compliant Cleaning Validation Management System Based on the Draft Guidance on Data Integrity

In pharmaceutical manufacturing, risk of contamination is caused from a broad range of factors such as cross contamination (other pharmaceutical active ingredients), cleaning agents and micro-organisms.

Additionally, the risk of contamination may in some cases be from a calculation error which results in choosing the wrong Maximum Carry-Over Limit (MAC). For example, can you consider the number of calculations required for an equipment train, with twenty (20) sample points, having different surface areas (swab sample area), different sampling types (swab/rinse), five (5) products manufactured on the equipment train, and each product has ten (10) production stages, and two (2) different cleaning agents are used. There is a huge risk associate with calculating the Maximum Carry-Over Limit (MAC) manually.

Automation has played a key role in decreasing risks associated with various processes. Data integrity is an important component of the industry’s responsibility to ensure the safety, efficacy and quality of pharmaceutical products.

Susan Cleary
Director, Product Development
Novatek International

5:00

Close of Day Two

DAY THREE THURSDAY, AUGUST 23, 2018

8:00

Continental Breakfast

8:30

INTERACTIVE SESSION Mock Cleaning Validation Inspection

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

10:00

Networking and Refreshment Break; Office Hours
Meet one-on-one with speakers to solve your individual cleaning validation challenges

10:30

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (5-6)

Session 5 Statistical Process Control —
Control Chart Creation and Interpretation

I. Statistical Process Control (SPC)

II. Control Charting Basics Using Microsoft Excel

Douglas Brown, PhD
Research Scientist, Methods Development and Validation, Biologics Testing Solutions
Charles River Laboratories, Inc.

Session 6 Methodology for Evaluating Protein Inactivation During Cleaning and Sterilization — Applications to Changeovers and Setting Acceptance Limits in Multi-Product Facilities

As pharmaceuticals have become more potent over the years, cleaning validation acceptance limits for APIs have declined steadily. The lower acceptance limits have led to several issues such as longer cleaning and equipment turnaround times, and lower success rates for cleaning operations. These issues have substantially increased the cost and duration of validation campaigns, and the risk of delays to new product launches. Additionally, the advent of high potency products with extended half-lives has heightened regulatory scrutiny of potential cross-contamination in multi-product facilities. Strategies for addressing these issues are presented with recent case studies.

Rizwan Sharnez, PhD
Founder and Owner, Cleaning Validation Solutions;
Former Scientific Director, Amgen

12:00

Networking Luncheon

1:00

CHOOSE BETWEEN TWO 90-MINUTE SESSIONS (7-8)

Session 7 Establish a Compliant
Disinfectant Efficacy Program

I. Application of the Assay

II. Develop and Perform the Method

III. Interactive Exercise

Crystal Booth, MM
Senior Director, Corporate Quality
Avista Pharma Solutions

Session 8 The Next Step in the CV Lifecycle —
Creating and Maintaining a Monitoring Program for Validated Cleaning Processes

I. Why Have a Cleaning Monitoring Program?

II. Where to Start

III. Creating Your Monitoring Program

IV. Implementation

V. Maintaining the Monitoring Program

VI. Maturing the Monitoring Program

VII. Interactive Discussion — Watch Outs and Pitfalls

Ed Rose
Staff Validation Engineer
Johnson & Johnson Consumer Inc. (Invited)

2:30

Networking and Refreshment Break

3:00

Long-Term Storage and Return to Service of Equipment

I. Understand the Difference between Normal Production and Long-Term Storage

II. Factors Affecting Long-Term Storage

III. Return to Service

IV. Interactive Discussion

Jenna Carlson
Director, Quality Assurance
Coherus Biosciences

4:30

Close of Conference