Tuesday, June 7 @ 11:30AM EDT (8:30AM PDT)
“Quality & Regulatory Webinar: Quality Advice for Virtual Pharmas”
Join us for a webinar that features best-practice advice for virtual pharmas on the timely adoption of quality and document management systems to mitigate risk and facilitate successful launches, including topics such as:
- Is your team adopting the best approach or just imitating what worked in the past for big pharma?
- How do you extend your Quality systems/processes to external partners?
- When is the optimal time to adopt a formal QMS/DMS solution as you approach launch?
Have the opportunity to WIN a $100 Amazon gift card by registering and attending!
- Jeff Ketelhut, CIO, Atara Biotherapeutics
- Greg Cathcart, CEO, Excellis
- Jose Sifontes, President of Quality & Regulatory, Excellis
- DSCSA regulation update, timelines and operational implications
- Office of Inspector General (OIG) March 2018 Report
- Federal Drug Administration 2 new guidances
Purchasing or replacing a Track and Trace DSCSA Technology Solution? Learn the 5 key elements to ensure a great selection in meeting your organization’s needs. Learn About…
- DSCSA regulation update & timelines for consideration in selecting a technology solution
- Compliance and operational value – can both be achieved with a technology solution?
- Key elements in comparing and selecting a technology solution
- Considerations of pharmacy manufacturers serializing product by 11/2018
- Advantages for the pharmacy supply chain
- Why are so many organizations considering changing solution vendors?
- Key Elements to ensure compliance and improve medication & patient safety
- Implications and Opportunities of the November 2017 electronic lot traceability date
- FDA’s 11/27/2017 guidance regarding grandfathering product & implications for healthcare and retail
OIG and FDA latest report/guidance & Are you prepared for Electronic Lot Traceability November 2017 Deadline Impact
- What are the implications of Wholesalers exchanging drug product tracing information using a wide variety of transmission modes and formats?
- Are direct purchase statements accurate with the required information?
- How is the determination of DSCSA exempt and non-exempt products? How trading partners might resolve/prevent disagreements?
- 340B pharmacies: What is the latest guidance regarding the exchange of drug product tracing information for sales to 340B-covered entities that use 340B contract pharmacies?