3-Day Livestream Salon
Compounding Pharmacies:
Achieving Quality through Processes and Procedures
DATE: August 18, 19, 20 2020
Speakers
Keynote
Gail Bormel
Acting Associate Director, FDA/CDER
Keynote
Keynote: FDA Viewpoint on Compounding During Covid-19: Emergency Response to a Pandemic
- Discuss FDA policy development for compounding during the COVID-19 public health emergency
- Outline challenges faced during the COVID-19 pandemic and FDA response
- Discuss lessons learned to date
Panelist, Speaker
Ian Deveau
Division Director (Acting), 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
Seth DePasquale, RPh
Co-Owner & Pharmacist in Charge, BET Pharmacy
Session
Presentation: Achieving Quality through Compliance Training Programs
Panel, Round Table Moderator
Karla L. Palmer
Hyman, Phelps & McNamara,P.C.
Session
Panel: How to Integrate Compliance Procedures into Business Activities
Round Table: Managing Reclassification of Drugs to Biologics
Speaker, Round Table Moderator
Alexander Pytlarz, PharmD
Pharmacist, President of Operations, Infuserve America
Session
Presentation: Design and Workflow for Compounding Safety
Round Table: Managing a Post Covid-19 Workforce
Round Table Moderator
Melissa Stefko
Vice President of Quality Assurance, Wells Pharmacy Network, LLC
Session
Round Table: California Board of Pharmacy Regulations (503a and 503b) roundtable
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, 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, Panel Moderator
Lee H. Rosebush
Partner, Baker Hostetler LLP
How the Pandemic has affected the Legal Drugs Manufacturing Business
Session
Panel: Industry Response to Covid-19
Round Table: How to Address Concerns Raised by FDA With A Limited Budget
Round Table Moderator, Panelist
Kimberly Kieffer
Director of Regulatory Affairs, Empower Pharmacy
Hear Kim talk about her background and sessions
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
Round Table Moderator
Kristopher Le, Pharm.D.
CEO and Principal Consultant, AMICUS cGMP Consulting
Session
Round Table: Environmental Monitoring Performance Qualification and Risk Based Sampling
Round Table: Process Validation Design and Execution
Speaker, Panelist
Thomas C. Kupiec, Ph.D.
President & CEO, ARL Bio Pharma, Inc. DNA Solutions, Inc. The Kupiec Group LLC
Session
Panel: Industry Response to Covid-19
Presentation: TBA
Speaker
Bryan Prince
Compounding Workflow & Lab Design Specialist, Lab· Red Pharmacy Consultants
Session
Presentation: 503A: Facility Design and Engineering for USP Compliance
Speaker, Round Table Moderator
Carlos M. Aquino
Compliance Consultant & Founder, PharmaDiversion LLC
Session
Round Table: How to Survive a DEA Inspection Series: Compounding a Controlled Substance
Round Table: How to Survive a DEA Inspection Series: Neglected Processes That Will Trip You Up with DEA
Round Table Moderator
Rick Meyer
President, Superior Laboratory Services, Inc.
Session
Round Table: 503B: Optimal Facility Design: Buy or Build
Round Table Moderator, Panelist
Jill Hunter, RPh, MBA
Founder, UpLevel To Lead
Session
Round Table: How to Move from a USP to a GMP Mentality
Round Table: How to Carry-Out FDA Recommended Automation on A Budget
Speaker
Varsha Gaitonde
Vice President, Pharmacy Servicess, QuVa Pharma
Session
Presentation: How to Choose A 503B and 503A Vendor for Your Hospital
Round Table Moderator
Gina Gilsoul
Quality Control Officer, Union Avenue Compounding Pharmacy
Session
Round Table: Best Practices for Standardizing Compliance Processes for 503A’s
Panel Moderator, Panelist
Travis Leeah
VP Clinical Services and Pharmacist in Charge, QuVa Pharma Inc.
Session
Panel Discussion: Successfully Negotiating State and Federal Regulatory Agencies
Panel Discussion: How to Integrate Compliance Procedures into Business Activities
Round Table Moderator, Panelist
Syed Saleem DPh, MBA,
Director/ PIC, Right Value Drug
Session
Panel: Managing Information for Compliance, Surveys and Inspections
Panel: Managing State and Federal Agencies
Round Table: Moving from a 503B to Generic Drug Manufacturer
- Outline the 503 B history and its current role in the pandemic
- Describe how can the current 503B role be expanded post COVID -19?
- Explain how 503 B can be helpful as generic manufacturers in assisting with lowering the cost of medications to patients
Opening Remarks
Darshan Kulkarni Pharm.D, MS, Esq.
General Counsel & Chief Compliance Office at Embedded Healthcare
Session
TBA
Round Table Moderator
Alain Frix
Advisor, CT Supply Chain Design & Management @ Chorus, Eli Lilly and Company
Session
Continually Improve Sterile Compounding Practice using In-House data and QBD Methods
- Summarize the many types of quality assurance data associated with sterile compounding
- Present methods for collecting and forming integrated electronic datasets, from the varied sources
- Present data analysis and visualization approaches including tabulations and graphs, and discuss setting thresholds, creating specifications, and identifying trends
- Describe and apply a “Quality By Design” approach to the overall quality assurance program
- Select and rank “Critical Quality Attributes” from the many sources and data types
- Provide a Quality Assurance, Production, and Statistical Analysis perspective on Quality, in this context
Round Table Moderator
Robert B. MacArthur, PharmD, MS, BCSCP
Director of Pharmacy, The Rockefeller University Hospital
Session
Continually Improve Sterile Compounding Practice using In-House data and QBD Methods
- Summarize the many types of quality assurance data associated with sterile compounding
- Present methods for collecting and forming integrated electronic datasets, from the varied sources
- Present data analysis and visualization approaches including tabulations and graphs, and discuss setting thresholds, creating specifications, and identifying trends
- Describe and apply a “Quality By Design” approach to the overall quality assurance program
- Select and rank “Critical Quality Attributes” from the many sources and data types
- Provide a Quality Assurance, Production, and Statistical Analysis perspective on Quality, in this context
Round Table Moderator
Nicholas Capote, PharmD, MS, BCSCP
Pharmacy Manager at Tufts Medical Center
Session
Round Table: Ways for Hospitals to addresss drug shortages
Round Table Moderator
Alex McClung
Global Vice President, Quality Assurance, Catalent Pharma Solutions
Session
Continually Improve Sterile Compounding Practice using In-House data and QBD Methods
- Summarize the many types of quality assurance data associated with sterile compounding
- Present methods for collecting and forming integrated electronic datasets, from the varied sources
- Present data analysis and visualization approaches including tabulations and graphs, and discuss setting thresholds, creating specifications, and identifying trends
- Describe and apply a “Quality By Design” approach to the overall quality assurance program
- Select and rank “Critical Quality Attributes” from the many sources and data types
- Provide a Quality Assurance, Production, and Statistical Analysis perspective on Quality, in this context
Round Table Moderator
Brian M Spencer
Director Quality Assurance, Chorus, Eli Lilly and Company
Session
Continually Improve Sterile Compounding Practice using In-House data and QBD Methods
- Summarize the many types of quality assurance data associated with sterile compounding
- Present methods for collecting and forming integrated electronic datasets, from the varied sources
- Present data analysis and visualization approaches including tabulations and graphs, and discuss setting thresholds, creating specifications, and identifying trends
- Describe and apply a “Quality By Design” approach to the overall quality assurance program
- Select and rank “Critical Quality Attributes” from the many sources and data types
- Provide a Quality Assurance, Production, and Statistical Analysis perspective on Quality, in this context
Ask us about sponsorship or team discounts:
E: Sales@pharmasalon.com T: 201-234-8544
Days until event
Day(s)
:
Hour(s)
:
Minute(s)
:
Second(s)
Establish policies and proceedures that will help your team best practices
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
Limited number of attendees
Hours of networking and peer-to-peer learning at each event
Years at each event of executive experience for solving the most challenging problems in life sciences
Days of community involvement
Suggest an Event or Just Get In Touch
