FACT Quality Boot Camp in Partnership with ASFA and ISCT

Time

Mins

Title

Description

7:30 am CT

12:30 GMT

30'

Networking Lounge

Description: We invite you to join your colleagues in the FACT Quality Boot Camp Networking Lounge this morning and then again during your lunch break! Let's face it, social distancing has us feeling disconnected and a bit exhausted. It is important to maintain relationships with co-workers and colleagues. Coming together for networking and social time with your colleagues is a great way to brighten the day. So grab a cup of coffee and connect!

8:00 am CT

13:00 GMT

15’

Welcome

Description: Boot Camp hosts Ed Brindle and Leigh Gates welcome all participants to the FACT Quality Boot Camp, in partnership with ASFA and ISCT. The hosts will share tips to help make your virtual boot camp experience flawless.

8:15 am CT

13:15 GMT

45’

Presentation

Change Control & Feasibility Needs: Adding IEC Service to Your Existing Program

Description: Dr. Schwartz, the Division Director of Transfusion Medicine and Cellular Therapy at New York Presbyterian Hospital/Weill Cornell Medical Center, will explain the relationship between change control and the feasibility needs assessment process when adding a new process to a program.  Dr. Schwartz will provide example documents commonly used in both processes.

9:00 am CT

14:00 GMT

45’

Presentation: Translating Risk Assessment into Practice

Description: Phillip Johnson, the Director/Scientific Director from the Queensland Cord Blood Bank at the Mater, will explain how to develop a tool that could be used to document the assessment and management of risk, evaluate risk using the tool, identify risk control measures, and integrate risk assessment into other quality management activities.

9:45 am CT

14:45 GMT

05’

Break

Transition to interactive session.

9:50 am CT

14:50 GMT

30’

Apheresis

Interactive Session: Risk Assessment

Processing

10:20 am CT

15:20 GMT

15’

Break

Morning Break

10:35 am CT

15:35 GMT

60’

Presentation: 

Getting the Train Moving Successfully with Process Validations

First 15 minutes - Overview of Risk Assessment Activity

Description: Wade Atkins, the Supervisor of Quality Assurance and Regulatory Affairs in the Department of Transfusion Medicine, Clinical Center, at the National Institutes of Health will review differences between qualification, validation, and verification.  He will review examples of these concepts and how they are used in Apheresis and Processing.

11:35 CT

16:35 GMT

05'

Break

Transition to interactive session.

11:40  am CT

16:40 GMT

30’

Apheresis 

Interactive Session: Validation/Qualification

Processing

12:20 pm CT

17:20 GMT

30’

Lunch

Listen to the featured sessions or visit the Networking Lounge.

We invite you to join your colleagues in the FACT Quality Boot Camp Networking Lounge during the boot camp lunch break! Let’s face it, social distancing has us feeling disconnected and a bit exhausted. It is important to maintain relationships with co-workers and colleagues. Coming together for networking and social time with your colleagues is a great way to brighten the day. So, grab some lunch and connect!

12:50 pm CT

17:50 GMT

15’

JEOPARDY!

1:05 pm CT

18:05 GMT

05'

Break

Transition to presentation.

1:10 pm CT

18:10 GMT

60’

Presentation

Using Audit Findings to Improve Your Program: Root Cause & CAPA

First 15 minutes - Overview of Validation/Qualification Activity.

Description: Dr. Beres, Director of Regenerative Medicine at Advocate Aurora Health, will discuss how to develop a plan, write a comprehensive audit report, assess the underlying cause(s) of errors, and develop and implement applicable corrective and preventative action plans.

2:10 pm CT

19:10 GMT

05'

Break

Transition to interactive session.

2:15 pm CT

19:15 GMT

30'

Apheresis

Interactive Session: Audits, Root Cause Analysis, & CAPA

Processing

2:45 pm CT

19:45 GMT

15'

Break

Afternoon Break

3:00 pm CT

20:00 GMT

60’

Presentation

Unexpected Outcomes & Events: Chain of Custody and Chain of Identity

First 15 minutes - Overview of Audits, RCA, CAPA Activity.

Description: Dr. Joshi will discuss chain of custody and chain of identity as well as how to use these techniques when reviewing occurrences: unexpected outcomes and events, audit findings, and other occurrences.  She will demonstrate this process using examples from products involving external parties (e.g., NMDP, manufactures, departments outside your collection/processing facility).

4:00 pm CT

21:00 GMT

05’

Break

Transition to interactive session.

4:05 pm CT

21:05 GMT

30’

Apheresis 

Interactive Session: Unexpected Outcomes & Events

Processing 

4:35 pm CT

21:35 GMT

05’

Break

Transition to interactive session.

4:40 pm CT

21:40 GMT

30’

Closing

First 15 minutes - Overview of Audit Activity.

Description: Boot Camp hosts Leigh Gates and Ed Brindle will recap the entire day, reflect on productive conversations, and invite participants to share a take-away, action step, or highlight from the boot camp. We will also welcome a special guest to help us end off the day.

5:15 pm CT

22:15 GMT

30'

Optional Session

FACT Accreditation Portal Training

Join FACT's IT Business Analyst to learn more about the FACT Accreditation Portal. This casual session will include information about upcoming changes to the portal, discussion about portal best practices, live instruction on issues pertaining to attendees, and an opportunity to provide portal feedback. FACT is constantly seeking to improve the portal and develop new features to benefit the users. What features would you like to see?