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Agenda

Establish a Lifecycle Approach to Cleaning and Process Validation

August 20-22, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, AUGUST 20, 2019

7:30

Workshop Registration and Continental Breakfast

8:30

Workshop Leader’s Opening Remarks

PRE-CONFERENCE WORKSHOP Lifecycle Risk-Based Design of
Cleaning Processes and Cleaning Validation

I. Regulations, Requirements, Guidelines and Standards

II. Risk-Based Management

III. 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
Founder
Mindful Quality

1:15

A Lifecycle Approach to Cleaning Validation

Harshal Patel
Lead Validation Engineer II
Alkermes

2:00

Creating a Robust Cleaning Protocol and Report

Joe Cagnassola
Principal Validation Engineer
Alcon

3:00

Networking and Refreshment Break

3:30

Hear How to Implement a Successful Product Changeover Strategy

Jenna Carlson
Founder
Mindful Quality

4:15

CASE STUDY Integrate Cleaning Validation into Cross-Contamination Programs

Jordan Tholstrup
Program Manager, Remediation
Pfizer Inc

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, AUGUST 21, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Jenna Carlson
Founder
Mindful Quality

8:45

How Do I Clean That?
Critical Cleaning in the Pharmaceutical and Cosmetic Industries

Jeff Philips
Senior Director, Science and Marketing
Alconox, Inc.

9:30

Networking and Refreshment Break

10:00

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

Beth Kroeger
Technical Services Manager
STERIS Life Sciences

10:45

Recovery Studies on Different Substrates for Cleaning Validation

Sumeer Bhargava, M. Pharm
Director, Validation and QA Operations
Nesher Pharmaceuticals USA LLC

11:30

Lifecycle Approach to Product Qualification in the Rare Disease Space Using CMO Model

Alberto Gonzalez
Founder and President
Beacon Life Sciences

12:15

Networking Luncheon

1:30

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

Session 1 Bring Your Own Challenge

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

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

Session 2 Disruptive Approaches to Cleaning Validation Using Pharma 4.0 — A Digitization Think-Tank

Building on current trends for machine learning, artificial intelligence (AI) and the internet of things (IoT), this session examines how to digitize cleaning processes. Understand the in-built capabilities and learn to remove the need for people in harnessing the data analytics capability of existing manufacturing and testing equipment and instrumentation. New approaches to integrated and holistic design need to allow data collection and analysis for automated feedback to the process through machine learning — Without the need for human involvement. Continuous manufacturing with automated cleaning cycles built in are not a futuristic vision — They will be essential to the success of processes moving from 2020 to 2030. Chances are your company is not ready or is just moving into this vision. Come and learn how to disrupt out of date / tired approaches to cleaning and cleaning validation and move into the digital age.

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

3:00

Networking and Refreshment Break

3:30

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

Susan B. Cleary, BCS, MBA
Director, Product Development
NOVATEK

4:15

Interactive Session — Mock Cleaning Validation Inspection

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

Jenna Carlson
Founder
Mindful Quality

5:45

Close of Day Two

DAY THREE THURSDAY, AUGUST 22, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day Two

Jenna Carlson
Founder
Mindful Quality

8:45

Protein Inactivation and Degradation and Setting Cleaning Limits

Neti Hansen
Senior Technical Manager
Genentech, a member of Roche Group

9:30

Cleaning Limit Calculation

Mary Sexton
Production Validation Engineer
Servier Ireland Industries Ltd

10:30

Networking and Refreshment Break

11:00

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

Session 3 Current and Revised Approaches to
Cleaning of Primary Packaging Material

This session delves into concerns which should be addressed when primary packaging material is cleaned. Understand what is expected from the authorities, how it can be done and what you should be concerned about.

Mette Bøjer Jensen
Master of Science (Biotechnology), Wash & Sterilization Specialist
Novo Nordisk A/S

Session 4 Cleaning and Removing Biofilms

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN TWO 45-MINUTE SESSIONS (5-6)

Session 5 Risk Management Program Implementation
at a CMO

Alberto Gonzalez, CMC
QA Special Projects Lead
Ultragenyx Pharmaceutical

Session 6 Choosing Cleaning Validation Parameters and Worst-Case Products

Mary Sexton
Production Validation Engineer
Servier Ireland Industries Ltd

2:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, AUGUST 20, 2019

7:30

Workshop Registration and Continental Breakfast

8:30

Workshop Leader’s Opening Remarks

PRE-CONFERENCE WORKSHOP Lifecycle Risk-Based Design of
Cleaning Processes and Cleaning Validation

I. Regulations, Requirements, Guidelines and Standards

II. Risk-Based Management

III. 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
Founder
Mindful Quality

1:15

A Lifecycle Approach to Cleaning Validation

Harshal Patel
Lead Validation Engineer II
Alkermes

2:00

Creating a Robust Cleaning Protocol and Report

Joe Cagnassola
Principal Validation Engineer
Alcon

3:00

Networking and Refreshment Break

3:30

Hear How to Implement a Successful Product Changeover Strategy

Jenna Carlson
Founder
Mindful Quality

4:15

CASE STUDY Integrate Cleaning Validation into Cross-Contamination Programs

Jordan Tholstrup
Program Manager, Remediation
Pfizer Inc

5:00

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, AUGUST 21, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Jenna Carlson
Founder
Mindful Quality

8:45

How Do I Clean That?
Critical Cleaning in the Pharmaceutical and Cosmetic Industries

Jeff Philips
Senior Director, Science and Marketing
Alconox, Inc.

9:30

Networking and Refreshment Break

10:00

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

Beth Kroeger
Technical Services Manager
STERIS Life Sciences

10:45

Recovery Studies on Different Substrates for Cleaning Validation

Sumeer Bhargava, M. Pharm
Director, Validation and QA Operations
Nesher Pharmaceuticals USA LLC

11:30

Lifecycle Approach to Product Qualification in the Rare Disease Space Using CMO Model

Alberto Gonzalez
Founder and President
Beacon Life Sciences

12:15

Networking Luncheon

1:30

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

Session 1 Bring Your Own Challenge

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

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

Session 2 Disruptive Approaches to Cleaning Validation Using Pharma 4.0 — A Digitization Think-Tank

Building on current trends for machine learning, artificial intelligence (AI) and the internet of things (IoT), this session examines how to digitize cleaning processes. Understand the in-built capabilities and learn to remove the need for people in harnessing the data analytics capability of existing manufacturing and testing equipment and instrumentation. New approaches to integrated and holistic design need to allow data collection and analysis for automated feedback to the process through machine learning — Without the need for human involvement. Continuous manufacturing with automated cleaning cycles built in are not a futuristic vision — They will be essential to the success of processes moving from 2020 to 2030. Chances are your company is not ready or is just moving into this vision. Come and learn how to disrupt out of date / tired approaches to cleaning and cleaning validation and move into the digital age.

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

3:00

Networking and Refreshment Break

3:30

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

Susan B. Cleary, BCS, MBA
Director, Product Development
NOVATEK

4:15

Interactive Session — Mock Cleaning Validation Inspection

Karen Ginsbury
Founder and CEO
PCI Pharmaceutical Consulting Israel Ltd

Jenna Carlson
Founder
Mindful Quality

5:45

Close of Day Two

DAY THREE THURSDAY, AUGUST 22, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day Two

Jenna Carlson
Founder
Mindful Quality

8:45

Protein Inactivation and Degradation and Setting Cleaning Limits

Neti Hansen
Senior Technical Manager
Genentech, a member of Roche Group

9:30

Cleaning Limit Calculation

Mary Sexton
Production Validation Engineer
Servier Ireland Industries Ltd

10:30

Networking and Refreshment Break

11:00

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

Session 3 Current and Revised Approaches to
Cleaning of Primary Packaging Material

This session delves into concerns which should be addressed when primary packaging material is cleaned. Understand what is expected from the authorities, how it can be done and what you should be concerned about.

Mette Bøjer Jensen
Master of Science (Biotechnology), Wash & Sterilization Specialist
Novo Nordisk A/S

Session 4 Cleaning and Removing Biofilms

Dawn Tavalsky
Senior Director, Global Quality
Sanofi

12:30

Networking Luncheon

1:30

CHOOSE BETWEEN TWO 45-MINUTE SESSIONS (5-6)

Session 5 Risk Management Program Implementation
at a CMO

Alberto Gonzalez, CMC
QA Special Projects Lead
Ultragenyx Pharmaceutical

Session 6 Choosing Cleaning Validation Parameters and Worst-Case Products

Mary Sexton
Production Validation Engineer
Servier Ireland Industries Ltd

2:15

Close of Conference