Notice of Public Meeting

Experiences in Implementing Technical Provisions of 21 CFR Part 11; Electronic Records; Electronic Signatures

Last updated January 20, 2000

The Food and Drug Administration (FDA) is announcing a public meeting on industry's experience in implementing the technical provisions of 21 Code of Federal Regulations (CFR) Part 11; Electronic Records; Electronic Signatures.

FDA and the Parenteral Drug Association (PDA) are co-sponsoring this event. However, participation is not limited to the pharmaceutical industry; we invite all interested persons, from all FDA regulated industries, to participate.

The purpose of the meeting is to exchange information on the range of: (1) Experiences persons subject to part 11 have had in implementing the rule's technical provisions; and, (2) available products and services that enable implementation of those requirements. This will not be a forum to discuss the merits of the rule, nor a tutorial on the regulation; meeting attendees should have a basic understanding of part 11. Information presented at the event will assist FDA in developing future industry guidance documents with respect to part 11.

The scope of the meeting will be limited to implementation of part 11's technical requirements. This forum will focus on how persons subject to the rule are finding and using available enabling technologies. We are mindful of the rapid pace at which such technologies are changing and emerging, and the importance of keeping up with products and services that help ensure that electronic records remain trustworthy, reliable, and compatible with FDA's public health protection responsibilities.

The event is scheduled for:

Dates: June 19 and 20, 2000

Location:

The Wyndham Franklin Plaza Hotel

17th and Race Streets

Philadelphia, PA 19103

Phone: 215-448-2000

Abstracts of proposed presentations must be received by March 19, 2000. Handouts and related presentation materials for accepted abstracts must be received by May 19, 2000. Submit written comments by May 19, 2000.

We invite interested persons to give brief presentations about their experiences in implementing one or more of part 11's technical provisions. Likewise, we invite persons who provide enabling technologies specific to those requirements to give presentations addressing how they have been and can be applied to FDA regulated industries. In all cases, presentations must not exceed 20 minutes. Of particular interest would be presentations regarding modifications to electronic recordkeeping systems that were in use before August 20, 1997 (so called legacy systems.) Here are some examples of relevant topics:

Electronic Records Creation: methods of ensuring proper sequencing of electronic record entries and construction, use of technology to ensure validity of data input and operational instructions, and transaction controls to ensure that records are generated from the right data sources.

Electronic Record Integrity and Reliability: use of secure electronic audit trails that independently provide transaction date and time stamping of operator entries and actions that create, modify or delete electronic records; use of encryption and digital signatures in support of electronic record integrity and authenticity.

Electronic Signatures: use of biometric and digital signature technologies; linking electronic signatures to electronic records.

Archiving Electronic Records: methods of preserving electronic records, including content, structure, context, audit trail and other security attributes; migration from one file format and computing platform to another; ensuring accessibility by end users and FDA, especially when archiving to an environment different from the one in which the records were initially created.

If you would like to make a presentation at this meeting, send a brief abstract (no longer than one page), along with the speaker's name, affiliation, title, postal address, fax and phone numbers, and electronic mail address to:

Parenteral Drug Association
Attn: Ms. Angie Fischer, Program Director
7500 Old Georgetown Road
Suite 620
Bethesda, MD 20814

If you elect to send your abstract and speaker information by electronic mail, send the material in Adobe® PDF (Portable Document Format), or ASCII (American Standard Code for Information Interchange) format to fischer@pda.org.

FDA and PDA will jointly determine which abstracts to accept, and authors will be notified. Presentation handouts and related materials for accepted abstracts must be received by May 19, 2000. (Speakers who miss this deadline but wish to give meeting attendees copies of their material should bring sufficient copies with them at the time of the meeting.)

Send meeting registration requests, abstracts of proposed presentations and materials for accepted abstracts to:

Parenteral Drug Association
7500 Old Georgetown Road
Suite 620
Bethesda, MD 20814

To register for the meeting, contact the PDA at the above address. Also, see the association's Internet site at http://www.pda.org. If you need special accommodations due to disability, please inform the above PDA contact person when you register.

Interested persons, including those unable to attend or speak at the meeting, may send us comments regarding their experiences in implementing part 11's technical provisions, and their products or services that help people meet those requirements. Send paper comments on or before May 19, 2000 to:

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, room 1061
Rockville, MD 20852

For general information:

Dr. Steven Solomon
Office of Enforcement, Office of Regulatory Affairs (HFC-240)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

phone: 301-827-0386 fax: 301-827-0343
e-mail: ssolomon@ora.fda.gov

For information about registration for the public meeting:

Ms. Angie Fischer
Program Director
PDA
7500 Old Georgetown Road, Suite 620
Bethesda, MD 20814

phone: (301) 986-0293 x129 fax (301) 986-0296
e-mail: fischer@pda.org

(Hypertext updated by jch 2000-FEB-03)