[IEEE-bhpjobs] April 5th meeting about HIPAA Security and Part 11

[Esther L.]

Folks -
The SoCRA meeting on April 5th will be about HIPAA and 21 CFR Part 11.
I recommend that people send email to Juliette_Nelsen at med.unc.edu and
request to attend this meeting as a guest.
Esther Lumsdon

-- 
-- Esther L. esther_l at ieee.org, 

Subject: SoCRA - North Carolina Chapter (Durham/RTP) April 5, 2004                                            
                                                             

Dear Colleague:

The April meeting of the NC SoCRA Chapter is scheduled for Monday April 5, 2004 - 6:00 PM to 7:00 PM

The meeting will be held at the Duke Clinical Research Institute (DCRI) in the North Pavilion on the Duke Campus


Our Topic:
         "Now We Have to Worry About HIPAA Security AND Part 11??"

Computer systems are increasingly being used at clinical sites for trial
data collection, administration, and drug accountability activities.  In
many cases, clinical sites have not done a consistent job of adequately
protecting electronic records used in clinical research.  This can lead to data integrity headaches for sponsors in terms of their research data (and the defensibility of that data later).  Many sites will need to be
compliant with the new HIPAA Security regulation next year, and there are several similarities with FDA regulations for electronic records.  This talk will cover how CRAs (monitors) can use this regulation to their advantage to help clinical sites understand computer security controls. For clinical sites, this talk will provide basic coverage of some of the main points of the HIPAA Security regulation, and how they can "kill two birds with one stone" (HIPAA and FDA regulations) by implementing standard practices.

This presentation will cover an overview of:
·         Key concepts of the HIPAA Security Regulation (45 CFR Part 164
Subpart C)
·         The overlap between HIPAA security and 21 CFR Part 11
·         How organizations can leverage this new requirement in terms of clinical research record integrity

The audience will gain a basic understanding of the security regulation and the overlap with 21 CFR 11.  This should assist them in determining how to implement computer system procedures in their regulated environment in the context of clinical trials.


Our Speaker:
Lisa A. Olson
Principal Compliance Consultant

Lisa  Olson, Principal Compliance Consultant, has a professional background spanning  over  25  years  in the information technology field, 18 years of which  were  in  clinical  research  in  the  pharmaceutical industry.  Her experience  included  I.T.  system  development  and  project management at Parke-Davis  (now  part  of  Pfizer).  As Director of System Validation and
Compliance  at  ClinTrials  Research  (now  Inveresk),  she  established an organizational  unit focusing on regulatory compliance of computer systems. Her  experience  includes several different types of clinical applications, including  clinical  data  management,  adverse  event  reporting, clinical supplies,  and  Phase  1  operations.   Ms.  Olson  is a graduate of Albion College in Michigan.

Ms. Olson has proven instrumental in determining the compliance of computer systems  to  21 CFR 11 (Part 11, the FDA's regulation on Electronic Records and  Electronic  Signatures) and in performing risk assessments of proposed solutions/approaches.    Her  experience  also  includes  training,  system assessments  for  gaps  with  Part  11  compliance; development of standard procedures, and auditing service providers for regulatory compliance.

Ms. Olson maintains an understanding of industry needs as a member of the Society of Quality Assurance, including the Computer Validation Initiative Committee and Clinical Specialty Section.  She is a member of the Security committee in the North Carolina Healthcare Information and Communications Alliance, which is focused on the HIPAA regulations for patient privacy and security of medical records.  She is a frequent speaker at industry conferences and is a co-author of a book entitled The "New" Part 11 and Drug Development:  A Q&A Reference Guide released in March 2004 through Barnett International.

 If  anyone  has  any  questions,  please contact me at any of the contacts below:

Juliette M. Nelsen, MS, MT, CCRP, RAC
Protocol Review Committee Coordinator, Regulatory Associate
 Lineberger Comprehensive Cancer Center
Third Floor Administrative Tower
CB # 7295 University of North Carolina
Chapel Hill, North Carolina 27599-7295
 Juliette_Nelsen at med.unc.edu <mailto:Juliette_Nelsen at med.unc.edu>
Phone (919) 843-6901
FAX (919) 962-2621
Pager 216-1665
WEB SITE: http://cancer.med.unc.edu/research/PRC/
<http://cancer.med.unc.edu/research/PRC/>

The meeting will be held at the Duke Clinical Research Institute (DCRI) in
the North Pavilion on the Duke Campus. The North Pavilion is located at
2400 Pratt Street. All attendees should park in the adjacent parking
garage.  A ticket must be taken to lift the gate, but no attendant will be
on duty and the gate will be up when you exit.  The meeting will be from
6:00-7:00 in the 7th floor conference room (7015). Take the elevators to
the 7th floor and exit toward the receptionist's desk.  The door to her
left leads to the conference room.  Hit the Handicap plate to release the
door and it will open automatically.  The conference room is immediately on
your right. Please sign in at the front table.


Directions to Duke University North Pavilion From I-40 West take the Durham
Expressway/ NC 147 (Exit279B) Continue on the Durham Expressway. Exit on
Hillandale Rd. / Fulton St. (exit15b) Stay in the left lane. At the light
at the bottom of the ramp, turn left onto Fulton Street. Go past the
parking garage and North Pavilion Buildings Turn left onto Pratt St., Take
the first drive on the left, at the stop sign, turn left again towards the
front of the building Enter garage at the Patient and Visitor Only
entrance. You will need to take a ticket to enter. The numbers of the
garage floors do not match the floors in the building, so the main entrance
of the building is actually Floor 2 of the garage. As soon as you enter the
building (security is on your right), a flight of stairs is directly in
front of you. Turn left and proceed to the elevators. The meeting room is
on the 7th floor.  Room 7015.

>From Charlotte, Greensboro and areas West of Durham -Take 85 North, past
Greensboro, Burlington, 85 will merge with 70, and later with 15-501
by-pass Get off exit at Hillandale Road, Exit 174 Turn right, go past the
Hillandale Golf course Continue straight, go under 147, Street name will
change to Fulton Go past the Duke University parking garage and North
Pavilion Buildings Turn left onto Pratt Street, which is the first left
Continue on Pratt (very short road). Take your first left. At the stop
sign, turn left again toward the front of the building Enter garage at the
"Patient and Visitor Only" entrance. You will need to take a ticket to
enter. The numbers of the garage floors do not match the floors in the
building, so the main entrance of the building is actually Floor 2 of the
garage. As soon as you enter the building (security is on your right), a
flight of stairs is directly in front of you. Turn left and proceed to the
elevators. The meeting room is on the 7th floor. Room 7015.