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

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?

  • Key provisions of the law
  • Buried requirements in the regulations
  • Guidances — what you don’t know will hurt you
  • Warning letters — more hidden requirements
  • Why does FDA care?
  • Exercise: Attendees determine if a recordkeeping statement is a hidden regulatory requirement

Speaker: John Avellanet

10:00 a.m. – 10:30 a.m.

FDA’s Hidden Agenda for Record Integrity

  • FDA inspections — questions FDA investigators ask to find gaps in your documents and untrustworthy records
  • FDA warning letters — who’s been cited for what?
  • FDA enforcement actions — who has FDA prosecuted and enjoined?
  • FDA concerns — digital v. paper records
  • Exercise: Attendees act as FDA investigators in three different case studies

Speaker:  John Avellanet

10:30 a.m. – 10:45 a.m.


10:45 a.m. – 11:10 a.m.

Dangers of Working in the Drug and Device Industry     

  • Why drug and device firms are subject to intense scrutiny
  • Role play: Techniques that lawyers and third parties use to twist the meaning of words.
  • Who in a company can be held criminally liable for failure to comply with requirements?
  • How FDA will determine who is responsible for which activity
  • Self-analysis: Attendees determine their personal exposure

Speaker: Nancy Singer

11:10 a.m. – 12:00 p.m.

Company Communication: Who’s Reading Your Documents?

  • Are your documents communicating what your reader needs to know?
  • Points to consider when writing documents for internal audiences
  • Exercise: How employees get burned when writing documents for external audiences

Speaker: Nancy Singer

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 1:30 p.m.

Records as Evidence – How It Can Help or Hurt You

  • Exercise: Differentiating between facts and opinions
  • The weight that should be given to different types of opinions
  • Who should write opinions on regulatory issues and who should stick to the facts
  • Role play: How informal opinions can be introduced as evidence

Speaker: Nancy Singer

1:30 p.m. – 2:00 p.m.

Creating Documents that Tell the Company’s Compliance Story

  • Exercise: Distinguishing between supported and unsupported statements
  • Complaints — capturing key information

Speaker: Nancy Singer

2:00 p.m. – 2:15 p.m.


2:15 p.m. – 3:00 p.m.

Creating Documents that Tell the Company’s Compliance Story (continued)

  • CAPA — the information that the FDA wants to see in your files
  • Writing documents in the active v. the passive voice
  • Exercise: How to write meeting minutes

Speaker:  Nancy Singer

3:00 p.m. – 4:00 p.m.

What to Toss, What to Keep and for How Long

  • Brief review of a retention schedule tool
  • Process for sorting through warning letters to find hidden requirements on how FDA wants you to keep your records
  • Understanding what “minimum” retention time really means
  • Exercise: How to prepare an FDA records retention schedule

Speaker: John Avellanet

4:00 p.m. – 5:00 p.m.

SOPs and Policies: Understanding Exactly FDA Wants to See for “Records as Proof”

  • Identifying records in every SOP
  • Good recordkeeping practices
  • Long term archiving and destruction
  • Exercise: Review an SOP to find the proof an FDA investigator would expect to see if the SOP was followed

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

  • Records required to demonstrate oversight
  • Supplier dossiers — the records of supplier oversight that the FDA expects to see under FDASIA
  • Dealing with data integrity/Part 11 at supplier
  • Exercise: FDA recordkeeping questions to ask your critical suppliers

Speaker: John Avellanet

10:00 a.m. – 10:15 a.m.


10:15 a.m. – 11:00 a.m.

What to Do When You Encounter Inappropriate Documents

  • The problems with CYA memos
  • Exercise: What to do when you receive an inappropriate email
  • Discussion: How to handle situations wherein you disagree with the opinion of your manager

Speaker: Nancy Singer

11:00 a.m. – 11:30 a.m.

Email and Social Media: The Unrecognized Threat

  • Exercise: The dangers of writing personal emails at work
  • How companies have gotten burned with inappropriate emails
  • Lessons learned from the inappropriate use of social media
  • Exercise: Words to avoid

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.