3-Day Livestream Salon
Compounding Pharmacies:
Achieving Quality through Processes and Procedures
DATE: August 18, 19, 20 2020
Agenda-at-a-Glance
503A Track
August 18
| 12:30 | Role of Compounding Pharmacies Post Covid-19: Capabilities, Liabilities and Emergency Response to Pandemics and Epidemics | Gail Bormel, Associate Director for Compounding, FDA (Acting) |
| 1:30 | 503 A & B: Inspection Preparation and Response | Rachael G. Ponitkes, Partner, Reed Smith LLP |
| 2:30 | Stability Testing; Science and Compliance | Thomas C. Kupiec, Ph.D, President, CEO, ARL Bio Pharma, DNA Solutions, Inc., The Kupiec Group LLC |
| 3:30 | Round Table Discussions | |
| Process Validation Design and Execution | Kristopher Le, CEO and Principal Consultant, AMICUS cGMP Consulting | |
| How to Survive a DEA Inspection Series: Neglected Processes That Will Trip You Up with DEA | Carlos M. Aquino, Compliance Consultant & Founder, PharmaDiversion LLC | |
| Attendee Suggested Session | Submit a topic |
August 19
Ian
| 12:30 | Establishing Process that Ensure Quality through Training Programs | Seth DePasquale, Founder, BET Pharm |
| 1:30 | Fireside Chat: Industry Response to Covid-19 |
Lee H. Rosebush, Partner, Baker Hostetler LLC, Ian Deveau, Division Director (Acting) FDA/CDER, Gabrielle Coselle,Policy Analyst, FDA. Thomas C. Kupiec, Ph.D., President/CEO, ARL Bio Pharma, DNA Solutions, Inc., The Kupiec Group LLC
|
| 2:30 | Managing Information for Compliance, Surveys and Inspections | Jonathan Ogurchak, Founder, CEO, Stack LLC |
| 3:30 | Round Table Discussions | |
| Managing a Post Covid-19 Workforce | Alexander Pytlarz, Pharmacist, President of Operations, Infuserve America | |
| Environmental Monitoring Performance Qualification and Risk Based Sampling | Kristopher Le, CEO and Principal Consultant, AMICUS cGMP Consulting | |
| Review Best Practices for Stability Testing and Beyond Use Dating | Helen McKnight, PharmD,MBA,BCSCP, Director of Pharmacy, Princeton Baptist Medical Center, Department of Pharmacy | |
| Best Practices for Standardizing Compliance Processes for 503A’s | Gina Gilsoul, Quality Control Officer, Union Avenue Compounding Pharmacy | |
| Attendee Suggested Session | Submit a topic | |
| 4:30 | Networking Cocktail |
August 20
| 12:30 | PANEL: How to Integrate Compliance Procedures into Business Activities | Karla Palmer, Director, Hyman, Phelps and McNamara PC |
| 1:30 | 503A: Facility Design and Engineering for USP Compliance | Bryan Prince, Compounding Workflow & Lab Design Specialist, Lab: Red Pharmacy Consultants |
| 3:30 | Round Table Discussions | |
| How to Carry-Out FDA Recommended Automation on A Budget | Jill Hunter, RPh, MBA, Founder, UpLevel To Lead | |
| How to Survive a DEA Inspection Series: Compounding a Controlled Substanc | Carlos M. Aquino, Compliance Consultant & Founder, PharmaDiversion LLC | |
| Managing Reclassification of Drugs to Biologics | Karla Palmer, Director, Hyman, Phelps and McNamara PC | |
| New Draft Guidance About Veterinary Compounds | Rachael G. Ponitkes, Partner, Reed Smith LLP | |
| California Board of Pharmacy Regulations (503a and 503b) | Melissa Stefko, Vice President of Quality Assurance, Wells Pharmacy Network, LLC | |
| Discussion on Transitioning from A 503A to 503B Pharmacy | Kim Kieffer, Director of Regulatory Affairs, Empower Pharmacy | |
| Attendee Suggested Session | Submit a topic |
503B Track
August 18
| 12:30 | Role of Compounding Pharmacies Post Covid-19: Capabilities, Liabilities and Emergency Response to Pandemics and Epidemics | Gail Bormel, Associate Director for Compounding, FDA (Acting) |
| 1:30 | 503 A & B: Inspection Preparation and Response | Rachael G. Ponitkes, Partner, Reed Smith LLP |
| 2:30 | Stability Testing; Science and Compliance | Thomas C. Kupiec, Ph.D, President, CEO, ARL Bio Pharma, DNA Solutions, Inc., The Kupiec Group LLC |
| 3:30 | Round Table Discussions | |
| Process Validation Design and Execution | Kristopher Le, CEO and Principal Consultant, AMICUS cGMP Consulting | |
| How to Address Concerns Raised by FDA With A Limited Budget | Lee H. Rosebush,, Partner, Baker Hostetler LLC | |
| How to Survive a DEA Inspection Series: Neglected Processes That Will Trip You Up with DEA | Carlos M. Aquino, Compliance Consultant & Founder, PharmaDiversion LLC | |
| Moving from a 503B to a Generic Drug Manufacturer | Syed Saleem DPh, MBA, Director, Pharmacist in Charge, Right Value Drug | |
| Design and Workflow for Compounding Safety | Alexander Pytlarz, Pharmacist, President of Operations, Infuserve America | |
| Attendee Suggested Session | Submit a topic |
August 19
| 12:30 | Establishing Process that Ensure Quality through Training Programs | Seth DePasquale, Founder, BET Pharm |
| 1:30 | Fireside Chat: Industry Response to Covid-19 | Lee H. Rosebush, Partner, Baker Hostetler LLC, Ian Deveau, Division Director (Acting) FDA/CDER, Gabrielle Coselle,Policy Analyst, FDA. Thomas C. Kupiec, Ph.D., President/CEO, ARL Bio Pharma, DNA Solutions, Inc., The Kupiec Group LLC |
| 2:30 | TBA (GMP) | Ian Deveau, Division Director (Acting) FDA/CDER |
| 3:30 | Round Table Discussions | |
| Managing a Post Covid-19 Workforce | Alexander Pytlarz, Pharmacist, President of Operations, Infuserve America | |
| Environmental Monitoring Performance Qualification and Risk Based Sampling | Kristopher Le, CEO and Principal Consultant, AMICUS cGMP Consulting | |
| Review Best Practices for Stability Testing and Beyond Use Dating | Helen McKnight, PharmD,MBA,BCSCP, Director of Pharmacy, Princeton Baptist Medical Center, Department of Pharmacy | |
| How to Move from a USP to a GMP Mentality | Kim Kieffer, Director of Regulatory Affairs, Empower Pharmacy | |
| Attendee Suggested Session | Submit a topic | |
| 4:30 | Networking Cocktail |
August 20
| 12:30 | PANEL: How to Integrate Compliance Procedures into Business Activities | Karla Palmer, Director, Hyman, Phelps and McNamara PC |
| 1:30 | 503B: Optimal Facility Design: Buy or Build | Rick Meyer, President, Superior Laboratory Services, Inc. |
| 2:30 | Panel: Successfully Negotiating State and Federal Regulatory Agencies | Travis A. Leeah, VP Clinical Services and Pharmacist in Charge, QuVA Pharma Inc |
| 3:30 | Round Table Discussions | |
| How to Carry-Out FDA Recommended Automation on A Budget | Jill Hunter, RPh, MBA, Founder, UpLevel To Lead | |
| How to Survive a DEA Inspection Series: Compounding a Controlled Substanc | Carlos M. Aquino, Compliance Consultant & Founder, PharmaDiversion LLC | |
| Managing Reclassification of Drugs to Biologics | Karla Palmer, Director, Hyman, Phelps and McNamara PC | |
| Discussion on Transitioning from A 503A to 503B Pharmacy | Kim Kieffer, Director of Regulatory Affairs, Empower Pharmacy | |
| New Draft Guidance About Veterinary Compounds | Rachael G. Ponitkes, Partner, Reed Smith LLP | |
| California Board of Pharmacy Regulations (503A and 503B) | Melissa Stefko, Vice President of Quality Assurance, Wells Pharmacy Network, LLC |
Hospital Pharmacies Track
August 18
| 12:30 | Role of Compounding Pharmacies Post Covid-19: Capabilities, Liabilities and Emergency Response to Pandemics and Epidemics | Gail Bormel, Associate Director for Compounding, FDA (Acting) |
| 1:30 | Hospital Pharmacies: Inspection Preparation and Response | Helen McKnight, PharmD,MBA,BCSCP, Director of Pharmacy, Princeton Baptist Medical Center |
| 2:30 | Stability Testing; Science and Compliance | Thomas C. Kupiec, Ph.D, President, CEO, ARL Bio Pharma, DNA Solutions, Inc., The Kupiec Group LLC |
| 3:30 | Round Table Discussions | |
| Process Validation Design and Execution | Kristopher Le, CEO and Principal Consultant, AMICUS cGMP Consulting | |
| Continually Improve Sterile Compounding Practice using In-House data and QBD Methods | Robert B. MacArthur, PharmD, MS, BCSCP, Director of Pharmacy, The Rockefeller University Hospital | |
| Attendee Suggested Session | Submit a topic |
August 19
| 12:30 | Establishing Process that Ensure Quality through Training Programs | Seth DePasquale, Founder, BET Pharm |
| 1:30 | Fireside Chat: Industry Response to Covid-19 | Lee H. Rosebush, Partner, Baker Hostetler LLC, Ian Deveau, Division Director (Acting) FDA/CDER, Gabrielle Coselle,Policy Analyst, FDA. Thomas C. Kupiec, Ph.D., President/CEO, ARL Bio Pharma, DNA Solutions, Inc., The Kupiec Group LLC |
| 2:30 | TBA (GMP) | Ian Deveau, Division Director (Acting) FDA/CDER |
| 3:30 | Round Table Discussions | |
| Managing a Post Covid-19 Workforce | Alexander Pytlarz, Pharmacist, President of Operations, Infuserve America | |
| Environmental Monitoring Performance Qualification and Risk Based Sampling | Kristopher Le, CEO and Principal Consultant, AMICUS cGMP Consulting | |
| Review Best Practices for Stability Testing and Beyond Use Dating | Helen McKnight, PharmD,MBA,BCSCP, Director of Pharmacy, Princeton Baptist Medical Center, Deptartment of Pharmacy |
|
| Examine Participants’ Challenges and Solutions to Addressing Hospital Drug Shortages | Nicholas Capote, Pharmacy Manager, Tufts Medical Center | |
| Attendee Suggested Session | Submit a topic | |
| 4:30 | Networking Cocktail |
August 20
| 12:30 | PANEL: How to Integrate Compliance Procedures into Business Activities | Karla Palmer, Director, Hyman, Phelps and McNamara PC |
| 1:30 | 503B: Optimal Facility Design: Buy or Build | Rick Meyer, President, Superior Laboratory Services, Inc. |
| 2:30 | Panel: Successfully Negotiating State and Federal Regulatory Agencies | Travis A. Leeah, VP Clinical Services and Pharmacist in Charge, QuVA Pharma Inc |
| 3:30 | Round Table Discussions | |
| How to Carry-Out FDA Recommended Automation on A Budget | Jill Hunter, RPh, MBA, Founder, UpLevel To Lead | |
| How to Survive a DEA Inspection Series: Compounding a Controlled Substanc | Carlos M. Aquino, Compliance Consultant & Founder, PharmaDiversion LLC | |
| Managing Reclassification of Drugs to Biologics | Karla Palmer, Director, Hyman, Phelps and McNamara PC | |
| New Draft Guidance About Veterinary Compounds | Rachael G. Ponitkes, Partner, Reed Smith LLP | |
| Attendee Suggested Session | Submit a topic |
Establish policies and proceedures that will help your team best practices
Days untill event
Day(s)
:
Hour(s)
:
Minute(s)
:
Second(s)
Who Should Attend
|
Quality Assurance |
General Counsel |
|
Quality Control |
Pharmacy Services |
|
Pharmacy Operations |
Facilities Management |
|
Owner / President / CEO |
Supervising pharmacist or non-pharmacist manager equivalent |
|
Compliance |
Facility manager |
|
Policy and Regulatory Affairs |
Infection control lead |
|
Legal |
Process improvement |
Industries
503A Pharmacies
503B Pharmacies
Hospital Pharmacies
Sessions
Round Tables
- Establishing Process that Ensure Quality through Training Programs
- Role of Compounding Pharmacies Post Covid-19: Capabilities, Liabilities and Emergency Response to Pandemics and Epidemics
- How to Integrate Compliance Procedures into Business Activities
- 503 A & B: Inspection Preparation and Response
- Looking to The Future of Inspections by FDA And Pharmacy State Boards
- Design and Workflow for Compounding Safety
- Transitioning From a 503A to 503B Pharmacy
- How to Address Concerns Raised by FDA With A Limited Budget
- How to Survive a DEA Inspection Series: Compounding a Controlled Substance
- Managing a Post Covid-19 Workforce
- Discussion on Transitioning from A 503A to 503B Pharmacy
Speakers
Keynote
Gail Bormel
Associate Director for Compounding at FDA (acting)
Keynote
Role of Compounding Pharmacies Post Covid-19: Capabilities, Liabilities and Emergency Response to Pandemics and Epidemics
- Discuss FDA expectations around compounding products in times of urgencies like pandemics
- Review ways of managing promotional compliance associated with compounded pharmaceuticals
- Outline innovations and updates based on COVID learnings
Panelist, Speaker
Ian Deveau
Division Director (Acting) at FDA/CDER
Sessions
Fireside Chat: Industry Response to Covid-19
– Identify how have compounding pharmacies and outsourcing helped during this pandemic
– Compare and contrast how the relationship between these facilities and FDA changed during the pandemic
– Looking backwards, summarize what could have been done differently to prepare us
– Discuss where things are heading post covid
Presentation: GMP – details to be announced
Panelist
Gabrielle Cosel
Policy Analyst, FDA
Session
Fireside Chat: Industry Response to Covid-19
– Identify how have compounding pharmacies and outsourcing helped during this pandemic
– Compare and contrast how the relationship between these facilities and FDA changed during the pandemic
– Looking backwards, summarize what could have been done differently to prepare us
– Discuss where things are heading post covid
Speaker, Round Table Moderator
Helen E. McKnight, PharmD, MBA, BCSCP
Director of Pharmacy, Princeton Baptist Medical Center, Department of Pharmacy
Session
Presentation:Hospital Pharmacies: Inspection Preparation and Response
Round Table: Review Best Practices for Stability Testing and Beyond Use Datings
Speaker and Round Table Moderator
Rachael G. Pontikes
Partner, Reed Smith LLP
Session
Presentation: 503 A & B: Inspection Preparation and Response
Round Table: New Draft Guidance About Veterinary Compounds
Round Table and Panel Moderator
Lee H. Rosebush
Partner, Baker Hostetler LLP
Session
- PANEL: Industry Response to Covid-19
- How to Address Concerns Raised by FDA With A Limited Budget
Round Table Moderator, Panelist
Kimberly Kieffer
Director of Regulatory Affairs, Empower Pharmacy
Session
Round Table: How to Move from a USP to a GMP Mentality
Panel: How to Integrate Compliance Procedures into Business Activities
Round Table: Discussion on Transitioning from A 503A to 503B Pharmacy
Speakers
Speaker
Lee H. Rosebush
Partner, Baker & Hostetler LLP
Session
How to Carry-Out FDA Recommended Automation on A Budget
Understand the importance of working with the CFO to establish minimum ROI
Establish vendors as partners and work with them on options; full automation, semi-automated or digital assistant
Review implementation strategies and required inhouse and by manufacturer validation as well as SOPs and training
Speaker
Jill Hunter, RPh, MBA,
Founder, UpLevel To Lead
Session
How to Carry-Out FDA Recommended Automation on A Budget
Understand the importance of working with the CFO to establish minimum ROI
Establish vendors as partners and work with them on options; full automation, semi-automated or digital assistant
Review implementation strategies and required inhouse and by manufacturer validation as well as SOPs and training
Speaker
Alain Frix
Advisor, CT Supply Chain Design & Management @ Chorus, Eli Lilly and Company
Session
Opportuities in investigative drug development with Pharma
Speaker
Darshan Kulkarni Pharm.D, MS, Esq
General Counsel & Chief Compliance Office at Embedded Healthcare
Session
Compliance, Fraud and Your Outsourced Sales Teams
Speaker
Shaun Noorian
Founder & CEO, Empower Pharmacy
Session
Moving from a 503A to a 503B
Speaker
Lauren Aller
VP of Compounding Operations at Clinical Compound Pharmacy
Session
Marketing: Details to be announced
Speaker
Greg McKettrick RPh
Director of Business Development Stanley Specialty Pharmacy
Session
Case Study: Marking – Details to be announced
Speaker
TBA
TBA
Session
TBA
