Technical Program

7:30 AM - 12:00 PM

Registration

8:00 AM - 8:30 AM

Morning Coffee

8:30 AM - 9:00 AM

Welcoming Remarks and Introduction

9:00 AM - 11:30 AM

Session I: Keynote Talks

1. Sau “Larry” Lee, FDA, The Role of APC in Journey to Modernize Pharmaceutical Manufacturing  

2. Venkat Venkatasubramanian, Columbia University, Frontiers of Advanced Process Control

3. Olav Lyngberg, J&J, The Journey of Implementing Advanced Process Control in the Pharmaceutical Industry

4. Marty Martin, Air Liquide, Lessons Learned from the Implementation of Advanced Process Control in Other Industries

11:30 AM - 12:00 PM

Panel Discussion with Keynote Speakers

12:00 PM - 1:00 PM

Lunch

1:00 PM - 2:00 PM

Session 2: Panel Discussion to Introduce and Discuss Following Topics:                                                                                                                

• Key terminology

• Role and relationship of APC with regards to QbD, PAT, continuous manufacturing and digital manufacturing

• Organization and governance for APC implementation/ maintenance

• Workforce force for APC: relevant competencies for integration of different disciplines (engineering, measurement, control)

2:00 PM - 2:15 PM

Coffee Break

2:15 PM - 4:15 PM

Session 3: Breakouts sessions:                                                                             

• Terminology alignments 

• APC Business case/challenges / development/ Implementation in Pharma/Biopharma

• APC opportunity in modular manufacturing, process intensification, integrated continuous manufacturing 

4:15 PM - 5:15 PM

Break Out Reports

5:15 PM - 5:30 PM

Day 1 Recap

7:30 AM - 12:00 PM

Registration

8:00 AM - 8:30 AM

Morning Coffee

8:30 AM - 8:45 AM

Summary Day 1

8:45 AM - 10:15 AM

Session 4: APC Case Studies I (Pharma, Automation vendors)

#1 Eion McManus, APC Ltd. Learning from development of APC applications for small molecules

#2 Ahmed Kashiff, Biogen Technical complexity of modeling to support APC implementation

#3 John Mack Perceptive Implementation of model based control

10:15 AM - 10:30 AM

Coffee Break

10:30 AM - 12:00 PM

Session 5: APC Case Studies II

#4 David Lauri Pia, Pfizer Manufacturing APC Implementation

#5 Tony Wang, Amgen Applying Advanced Control Strategies in Biologics Manufacturing to Improve Product Quality

#6 FDA/Christina Capacci-Daniel Facility Implementation of automation and APC

12:00 PM - 1:00 PM

Lunch

1:00 PM - 2:15 PM

Session 6: Breakout Discussions

• Regulatory impact, filing, opportunities, perceived hurdles, and solutions to address hurdles, regulatory and non-regulatory guidance - Tom

• Role of Quality and Lifecycle Management (Invite Quality Roles to provide their perspective. FDA can provide a speaker that discuss from GMP perspective), validation of APC, where to engage?

2:15 PM - 3:00 PM

Break Out Reports

3:00 PM - 3:20 PM

Coffee Break

3:20 PM - 4:45 PM

Session 7: Collaboration and Next Steps (a couple of short talks)  plus Panel Discussion

Talks that highlight opportunities to collaborate as an industry to drive the field forward and can highlight ongoing efforts (BPOG, NIIMBL, ASTM, RAPID etc.)

1. Martin Warman, ASTM Role of standards in supporting APC implementation
2. Malcolm Jeffers, IAAE Strengthening the capabilities of the workforce in APC

4:45 PM - 5:00 PM

Workshop Recap