Learning By Conversation
Why Join our monthly Salons:
- Participate in interactive session for brainstorming with experts and peers
- Access recordings of sessions for revisiting key points
- Choose from multiple round table discussions every month
- Gain concrete take-aways for immediate implementation
Compounding Monthly Salons
January: Fireside Chat – Creating Protocols for Effective Treatment Of Disorders Effecting the Brain
- How this came about, Treating Vets with traumatic brain injuries and ptsd – case study
- Demonstrate applications that can be applied to a wide variety of issues affecting literally every family in the U.S.
- Explore practice types and groups that could employ these protocols
February: Regulatory Update and Inspection Trends for 503As and 503B's
503A: Updates on USP 795, 797
503B: Trends in 503B Inspections
March: Retention and Hiring; Staff Development & Advancement
- Learn ways to develop a culture that makes employees want to stay and resist poachers who offer more money
- Gain an understanding of what millennials want in their job and their future
- Identify ways to promote internally and recognize different types of leaders and the roles they can play in your organization
April: 503A and 503B specific salons
503A –Technicians; Are you effectively moving into leadership roles?
- Identify all types of leaders and don’t expect them to be the same type of leaders – square pegs in square holes, round pegs in round holes
- Prepare for a different perspective then what you had at your previous job
- Solve problems of being new leaders through obtaining effective training
503B – Navigating the complexities of state licensing for 503Bs
- State licenses for 503B’s, outsourcing license, wholesale/distribution license, pharmacy license, manufacturing license?
- Required FDA Inspections and the pandemic struggle
- Disciplinary actions associated with FDA 483 Observations
- Pharmacists license required in states
May: Essentially A Copy – A Challenge for Both 503As and 503Bs
- Understand what drugs need to be compounded from an API
- Learn why? Is it primarily due to drug shortage or a clinical need?
- Review how hospitals attest a clinical need to purchase 503B products?
- Explore if the FDA drug shortage list accurately reflect shortages in the field?
- Hypothesize for 503As what is the primary driver to compound from API? Is it a patient specific
June: 503A and 503B specific salons
503A – Compliance: Abby Roth, Founder/Microbiologist, Pure Microbiology
- Identify the conflicts between USP 797 the FDA’s Insanitary Conditions Document
- Explain how USP 797 compliance intersects USP 800 compliance
- Evaluate your current operations for compliance opportunities
503B – How to address opioid state fee
- How many states do you currently pay the fees for? Do you anticipate the number increasing?
- Are the fees excessive for a 503B vs manufacturers?
- DO you see value in lobbying to get these fees reduced?
July: Preventing Process Deviations in A Fluctuating Workforce
- Explain why deviations are a big deal
- Identify what causes of major deviations
- Review what kind of deviations we are seeing
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 Compounding Pharmacies | Community Pharmacies |
| 503B Compounding Pharmacies | Specialty Pharmacies |
| Hospital Pharmacies | Nuclear Pharmacies |
| Cannabis | Pharmacogenomics |
