FACT Quality Boot Camp in Partnership with ASFA and ISCT

FACT Quality Boot Camp in Partnership with ASFA & ISCT

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May 21, 2021
7:30 am - 5:15 pm CT 
12:30 - 22:15 GMT

 

 

Time

Mins

 

Title

Description

 

7:30 am CT

12:30 GMT

30'

 

 

Networking with Colleagues

Description: We invite you to join Boot Camp hosts and your colleagues for pre-boot camp networking.  Even though we can’t meet in person, that doesn’t mean business — or the need to build relationships — stops.  During this session, we will provide you with all the meeting ins and outs and have a little fun together while preparing for a fabulous day! 

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:

Risk Assessment

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 Activity:

Risk Assessment


 

Interactive session

 

 

Processing Activity:

Risk Assessment

10:20 am CT

15:20 GMT

15’

 

 

 

Break

 

Morning Break

10:35 am CT

15:35 GMT

60’

 

Presentation: 

Validation/Qualification

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 Activity: 

Validation/Qualification 

 

 

 

Interactive session

 

 

 

 

 

Processing Activity 

Validation/Qualification

12:20 pm CT

17:20 GMT

30’

 

 

Lunch

 

Attend optional lunch sessions.

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:

Auditing, Root Cause Analysis, CAPA

First 15 min - 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 Activity: 

Audits, RCA, CAPA

 

 

Interactive session

 

 

Processing
Activity:

Audits, RCA, CAPA

2:45 pm CT

19:45 GMT

15'

 

 

Break

 

Afternoon Break

3:00 pm CT

20:00 GMT

60’

 

Presentation:

Unexpected Outcomes & Events

First 15 min - Overview of Auditing/RCA 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 Activity:

Unexpected Outcomes & Events

 

 

Interactive session

 

 

Processing Activity:

Unexpected Outcomes & Events

4:35 pm CT

21:35 GMT

05’

 

 

Break

 

Transition to interactive session.

4:40 pm CT

21:40 GMT

30’

 

Closing

First 15 min - 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.

5:10 pm CT

22:10 GMT

60'

 

Optional Session:

FACT Virtual Lounge

Description: Remember a time when we were able to meet at the end of the day to network, laugh, and share stories? Well, in an effort to restore some sort of normalcy, we invite you to join us in the FACT Virtual Lounge for happy hour! When you enter the lounge, you are able to see who's in the various lounge video rooms, join the room of your choice, and pop in and out of the lounge rooms at your leisure. Relax with your favorite drink, connect with your colleagues, talk shop, or just be social! A FACT representative will be stationed in each room.

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?