FDA Recordkeeping Agenda
FDA Recordkeeping
How to Prove Compliance and Avoid Dangerous Documents
Wednesday, July 17 – Thursday, July 18, 2013
Sheraton Boston Hotel
Boston, MA
Agenda
Day 1: Wednesday, July 17, 2013 |
|
8:30 a.m. – 9:00 a.m. |
Registration and Continential Breakfast |
9:00 a.m. – 10:00 a.m. |
FDA Records & Documents: What’s Really Required?
Speaker: John Avellanet |
10:00 a.m. – 10:30 a.m. |
FDA’s Hidden Agenda for Record Integrity
Speaker: John Avellanet |
10:30 a.m. – 10:45 a.m. |
Break |
10:45 a.m. – 11:10 a.m. |
Dangers of Working in the Drug and Device Industry
Speaker: Nancy Singer |
11:10 a.m. – 12:00 p.m. |
Company Communication: Who’s Reading Your Documents?
Speaker: Nancy Singer |
12:00 p.m. – 1:00 p.m. |
Lunch |
1:00 p.m. – 1:30 p.m. |
Records as Evidence – How It Can Help or Hurt You
Speaker: Nancy Singer |
1:30 p.m. – 2:00 p.m. |
Creating Documents that Tell the Company’s Compliance Story
Speaker: Nancy Singer |
2:00 p.m. – 2:15 p.m. |
Break |
2:15 p.m. – 3:00 p.m. |
Creating Documents that Tell the Company’s Compliance Story (continued)
Speaker: Nancy Singer |
3:00 p.m. – 4:00 p.m. |
What to Toss, What to Keep and for How Long
Speaker: John Avellanet |
4:00 p.m. – 5:00 p.m. |
SOPs and Policies: Understanding Exactly FDA Wants to See for “Records as Proof”
Speaker: John Avellanet |
Day 2: Thursday, July 18, 2013 |
|
8:30 a.m. – 9:00 a.m. |
Continental Breakfast |
9:00 a.m. – 10:00 a.m. |
Sponsor, Purchaser and Supplier Records — What to Include
Speaker: John Avellanet |
10:00 a.m. – 10:15 a.m. |
Break |
10:15 a.m. – 11:00 a.m. |
What to Do When You Encounter Inappropriate Documents
Speaker: Nancy Singer |
11:00 a.m. – 11:30 a.m. |
Email and Social Media: The Unrecognized Threat
Speaker: Nancy Singer |
11:30 a.m. – 12:00 p.m. |
How to Design a Program for Good Documentation Practices Speakers: Nancy Singer and John Avellanet |
12:00 p.m. |
Adjournment |