FACT Quality Boot Camp in Partnership with ASFA and ISCT

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-workshop 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 welcom 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:

Feasibility Needs Assessment/Change Control

Description: TBD

9:00 am CT

14:00 GMT

45’

Presentation:

Risk Assessment

Description: The presenter will guide programs through the process of risk assessment and execution of the plan.

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:  TBD

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: TBD

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:

Unexpted Outcomes & Events

First 15 min - Overview of Auditing/RCA Activity.

Description: TBD

4:00 pm CT

21:00 GMT

05’

Break

Transition to interactive session.

4:05 pm CT

21:05 GMT

30’

Apheresis Activity:

Unexpted Outcomes & Events

Interactive session

Processing Activity:

Unexpted 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

05'

Break

Transition to optional session.

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?