Live Salons
Oct 5: Inspection Preparations & Response
Oct: 6: Quality, Validation & Design
Oct 7: Environmental Monitoring
Oct 8: Leadership
SEPARATE
TRACKS
ENDURING CE CREDITS
DAYS TO VIEW PRESENTATIONS
Why Attend
- Obtain quality information through a combination of round tables, panel discussions, fireside chats and PPT presentations
- Actively learn through peer-to-peer conversations and the thoughtful decimation of data
- Build deep relationships through discussion of similar challenges
- Engage in powerful brainstorming for innovative solutions
- All sessions are recorded and can be viewed for CE credits up to one month after live event
Agenda-At-A-Glance
October 5: Inspection Preparation & Response
PRE-RECORDED (sessions released September 20)
What To Do To Prepare for an FDA Inspection
What to Expect During the Inspection
What To Do Following an FDA Inspection
How to Survive a DEA Inspection Series: DEA Inspection, Preparation & Response
LIVE
12:00 FDA Compounding Policy Update
3:00 Relevant USP Chapters: Where to Find All the Information
4:00 Salon: Discussion with audience Q&A
5:00 Virtual Cocktail Party
October 6: Quality, Validation and Design
PRE-RECORDED (sessions released September 20)
503A: Quality Assurance Means Quality Built In
503A: Introduction to Preparing and Resolving Deviations, OOS, and Other Discrepancies
503A: Creating a Testing Program
503B: Corrective Actions and Documentation
503B and 503A: Beyond Use Dating and Stability Testing Regulatory Clarification
503B: Qualifying Equipment With The Right Validations
LIVE:
3:00 503A: Salon: Quality, Verification & Design
4:00 503B: Salon: Quality, Validation & Design
5:00 End of Day
October 7: Environmental Design
PRE-RECORDED (sessions released September 20)
503A: PANEL: Designing an Environmental Monitoring Plan That Exceeds 797
503A: Environmental Monitoring for ISO8
503B: How You Mitigate Out Specification Findings Or Pathogenic Growth In Your Clean Room
503B: Guidance on Essential Copies For 503Bs
503B: Environmental Monitoring Trending Data
LIVE:
3:00 503A: Salon: Environmental Monitoring and Facility Design
4:00 503B: Salon: Environmental Monitoring and Facility Design
5:00 End of Day
October 8: Leadership
PRE-RECORDED (sessions released September 20)
Budgeting for USP 800
Technicians: Opportunities and Methodologies for Leadership Roles in Compounding Pharmacies
LIVE
11:30 MOU Update
1:00 Budgeting for UPS <800>
1:30 Fireside chate for Budgeting for USP <800>
3:00 Panel: Management: Grooming Your Technicians for Increased Responsibilities and Leadership Roles
4:00 Panel: Surviving USP and FDA Challenges: Adapting to Overcome Changes
5:00 End of Day
Agenda
Learning Through Conversation
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
Track Chairs
Growth and Alternative Revenue Streams
Dr. Jerrica Dodd
Founder/CEO Your Pharmacy Advocate, Executive Editor, PharmaSis Magazine
Compounding
Lou Diorio
Principal, LDT Health Solutions Inc
Cannabis
Joseph Friedman
Medical Cannabis Pharmacology Expert/Advocate, CannaRPh Consultants LLC
Pharmacogenomics
Jamie Wilkey
co-Founder, PGx Accelerators
Speakers
Compounding
Varsha Gaitonde, PharmD, PhD, BCPS, BCSCP
Vice President, Pharmacy Services, QuVa Pharma, Inc.
Session
CE, On Demand: 503B: Guidance on Essential Copies For 503Bs
In-Person: Essentially A Copy - A Challenge for Both 503A's and 503B's
Compounding
Wendy Hagwood
RPh, PIC, Ops Mgr at Triangle Compounding Pharmacy
Session
Round Table Moderator: Animals are people too
Compounding
Peter Koshland
CEO, Koshland Pharm
Session
Poaching and staff retention
Compounding
Rachael Pontikes
Partner, Reed Smith LLP
Session
CE, On-Demand: Inspection Preparation & Response: During
In Person: 503A Regulatory Update
Compounding
Matthew R. Ludowig
Senior General Counsel, Empower Pharmacy
Session
in-person: Essentially A Copy - A Challenge for Both 503A's and 503B's
Compounding
Lee Rosebush
Partner, BakerHostetler
Session
CE, On-Demand: Inspection Preparation & Response: Before
In-Person: 503B Regulatory Update
Compounding
Vicky A. Caldaro
Manager, Quality Operations , Immucor Inc.
Session
In-Person: Preventing Process Deviations in a Fluctuating Workforce
Compounding, Growth and Entrepreneurship
Syed Saleem DPh, MBA
Senior Director, NexGen Pharmaceuticals
Session
CE, On-Demand: 503B: Qualifying Equipment With The Right Validations
In-Person: TBA
General Session, Compounding
Jim Hrncir RPh
Owner, Las Colinas Pharmacy Compounding
Session
Fireside chat: Creating Protocols for Effective Treatment Of Disorders Affecting the Brain
Panel: Future of Compounding – Growth, Consolidation and New Opportunities
Panel: Retention and Hiring; Staff Development & Advancement
Compounding, Cannabis
Karla L Palmer
Director, Hyman Phelps & McNamara P.C.
Session
In-Person: Essentially a Copy, A Challenge for Both 503As and 503Bs
Compounding
Marc Wagner
Counsel, BakerHostetler
Session
Panel: 503B Regulatory Update
Round Table Moderator: 503B Inspections
Growth and Entrepreneurship, Cannabis
Greg McKettrick RPh
Compounding Pharmacist, Director of Business Development, Stanley Specialty Pharmacy
Session
In-Person: Success With Social Media - Increasing Your Customer Base Through Good Advice
Compounding, Workshop
Carlos M. Aquino
Compliance Consultant, Founder, Pharma Diversion LLC
Session
CE, On-demand: Inspection Preparation & Response: DEA
In-Person: Round Table Moderator, DEA Inspections, Workshop - DEA Inspections
Compounding, Workshop
Abby Roth
Owner/Microbiologist Pure Microbiology, LLC
Session
In-Person Workshop: Effectively writing and communicating SOP's
Compounding
Amy Summers PharmD, BCSCP
Consultant, Restore Health Consulting
Session
Moderator: Preventing Process Deviations in A Fluctuating Workforce
Compounding, Growth and Entrepreneurship
Emily L. Hussey
Attorney, Reed Smith LLP.
Session
CE, On-Demand 503A: Creating a Testing Program
In-Person: TBD
Compounding
Pat Stephens
Lead Consultant & Owner, Stephens Consulting
Session
503B Compliance:
Panel: Preventing Process Deviations in A Fluctuating Workforce
Growth and Entrepreneurship, Compounding
Alexander Pytlarz
Pharmacist, President of Operations, Infuserve America
Session
Fireside chat: Retention and Hiring; Staff Development & Advancement
Growth and Alternative Revenue Streams: Round Table on getting involved in Clinical Trials
Compounding
Devin Wallace CPhT CSPT RPhT PRS
Founder, CEO, Wallace Ventures
Session
Round Table moderator: Cited for what?! The push for CGMP like rules and standards in sterile facilities
Round Table: Are you effectively moving technicians into leadership roles
Compounding
Travis Leeah
Vice President Clinical Services and Pharmacist-in-Charge, QuVA Pharma
Session
Round table moderator: State licensing for 503B's
Round table moderator: How to address opioid state fees
Compounding
Jodi Peterson
President/Owner, Precision Compounding Pharmacy
Session
Round Table: Marketing – Traditional and Social Media Campaigns, Efficacy, do’s and don’ts as learned on the fron
Fireside chat: Retention and Hiring; Staff Development & Advancement
Compounding
Robert Hopkins
CFO, Empower Pharm
Session
503A: Relevant USP Chapters: Where to Find All the Information
Cannabis
Joe Jeffries
Pharmacy Director, FarmaceuticalRx
Session
| Fireside chat: using data from state prescription drug management program to show reduction on opioid use in lieu of cannabis |
Cannabis
Becky Brown
Doctor of Pharmacy Cannabis Educator & Coach Pharmedwell.com
Session
CE PRESENTER: Cannabis Pharmacology 101
ROUND TABLE MODERATOR: Building your external/auxiliary team
Cannabis
Jason S Nelson
COO, Beleaf Medical
Session
Panel: Discussion on Politics of Cannabis Treatment
Round Table Moderator: Different Q/A thresholds in different state markets
Cannabis
James T. O'Donnell
President, Consultant, Pharma consultant Inc., Associate Professor, Rush Medical College
Session
Round Table: Exploring The Science – ask your questions here
Fireside Chat – Legal Risks To Users
Cannabis
Robert Morris
Pharmacist, Beehive Farmacy
Session
Panel: Discussion on Politics of Cannabis Treatment
Round table: Routes of Administration and Cannabis and Cannabinoids Dosing
Cannabis
Erik Bowen
Owner,Illume Cannabis Wellness
Session
Panel Moderator: Utilizing Cannabis as A Therapy for Chronic Pain
Round Table: Fair Market Value of Pain Creams
Cannabis
Ashley Robins
Ashley Robins, Marketing and Policy Lead, ANJA
Session
Regulatory Update: Hemp – 2018 US Farm Bill – Delta 8 THC,Delat 9 THC, Delta 10 THC
Panel: Discussion on Politics of Cannabis Treatment
Cannabis
Lauren Vrabel
Cannabis Pharmacist, Scientific Advisor, The Cannigma
Session
Round table: Adverse event reporting
Panel: Risks to Patients that Need to Be Considered
Cannabis
Cassandray Gosa PharmD, MPH
Medical Cannabis Pharmacist, Founder, ChirpRX
Session
Panelist: Utilizing Cannabis as A Therapy for Chronic Pain Management
Round Table Moderator: 4th Year Rx Student APPE Clinical Rotation
Cannabis
Chad E. Burks, PharmD MBA MSMIT
VP, PIC, Westmoreland Clinical Services
Session
Panelist: Precision Medicine in Pharmacy: The Future of Clinical Management of Diseases
Round Table Moderator: Marketing – Getting Your Foot in The Door
Pharmacogenomics
Jeri Nichols, MS, PharmD, CGC
GenePharmer, LLC
Session
Panelist: Precision Medicine in Pharmacy: The Future of Clinical Management of Diseases
Panelist: Emerging Trends in Pharmacogenomics
Growth and Entrepreneurship
Melissa Myers, CFP
Wealth Manager-Melissa Myers’ Team Kar-Mel Financial Planners
Session
Panelist: How do you grow without a team?
Round Table: Financial planning for the future
Pharmacogenomics
Jena Quinn, PharmD, BCPPS
Business Owner, Perfecting Peds
Session
Panelist: Why Be Entrepreneurs, Creating Subsidiaries and Alternative Revenue Streams
Round table moderator: Maternal and pediatric
Panel and round table moderator: Marketing
Pharmacogenomics
DeLon Canterbury, PharmD, BCGP
African American COVID-19 Task Force (AACT+) President/CEO of GeriatRx, Inc.
Session
Panel: Lets Talk To The Consultants To Consult About Being A Consultant
Panel: Opportunities (and challenges) To Whole Health Care Team Acceptance
Round Table: Specialized Populations - Geriatric
Growth and Entrepreneurship
Dr. Jerrica Dodd
Pharmacist Coach, Executive Editor PharmaSis Magazine
Session
Are you stuck? Do you want to move forward in your life, become an entrepreneur, create new revenue streams for your business but find yourself unable to make any changes? Join Dr. Jerrica Dodd as she shares pearls and coaches on moving forward and building your dreams.
Panelist: How do you grow without a team?
Cannabis
Dr. Leah Johnson PharmD, RPh
Medical Cannabis Consultant Pharmacist, Alchemist Consulting
Session
Regulatory Update: Hemp – 2018 US Farm Bill – Delta 8 THC, Delta 9 THC, Delta 10 THC
Panel: Utilizing Cannabis as A Therapy for Chronic Pain Management
Panel: Risks to Patients that Need to Be Considered
Round Table: Improving patient relationships with practitioners
Pharmacogenomics
Kevin Lazaruk RPh, BCGP, BCMAS
LTC Consultant, Author
Session
Opportunities (And Challenges) To Whole Healthcare Team Acceptance
Reviewing clinical data Is utilizing clinical judgment and looking at the overall patient
General, Cannabis, Pharmacogenomics
Dr. Thomas Kupiec
CEO, ARL Bio Pharma, Inc and DNA Solutions
Session
Regulatory Update: Hemp – 2018 US Farm Bill – Delta 8 THC, Delta 9 THC, Delta 10 THC
Panel: Emerging Trends in Pharmacogenomics
Precision Medicine and the future management of diseases
FDA Online - October 20
Ian Deveau
Deputy Office Director, FDA
Session
October 20, Virtual presentation and fireside chat
FDA Online - October 20
Gabrielle Cosel
Director, Division of Compounding Policy and Outreach, Office of Compounding Quality and Compliance at FDA
Session
October 20, Virtual presentation and fireside chat
More Speakers To Be Announced
Vivian has been brilliant come to up with this idea. This reminds me of a lot of our thought leaders and the futuristic, progressive type talks we may be involved in. Thank you for providing topics that were relevant and speakers wanting to interact. FDA attendance is always appreciated as well. Fantastic program providing insight and strategy while earning CME!! Thank you to PharmaSalon for organizing a focused 503B program. I attended the Compounding Pharmacy Livestream in August 2020. It was the first virtual interactive CE program I had ever attended. Having the ability to interact with the speakers instead of just a webinar format made the event more impactful for me. I will definitely be attending more events by Pharmasalon.
