Home   Membership   OCRA Meetings  Other Meetings  Networking  
Partnerships   Links  Jobs  Consultants  BOD

 

RELATED LINKS

OCRA provides these links to various regulatory, quality and standards resources as requested
and recommended by members and makes no promises in connection with, nor bears any
responsibility for use of, the information resources listed below. 

General
Drugs
Devices
Biologics
Quality
Standards

GENERAL:

CFR Code of Federal Regulations (on-line)

The CFR online is a joint project authorized by the publisher, the National Archives and
Records Administration's Office of the Federal Register, and the Government Printing
Office (GPO) to provide the public with enhanced access to Government information.

Department of Health Services - State of California

California's Department of Health Services (DHS) Medical Device Safety Program.

Federal Register

Official daily publication for Rules, Proposed Rules, and Notices of Federal agencies and
organizations, as well as Executive Orders and other Presidential Documents.

Regulatory Resource

A collection of regulatory information guides and pointers on a user-friendly Web site.

Medical Device Forum

A place to exchange ideas and engage and question and answer sessions covering a comprehensive
range of regulatory issues.

FDA/HHS Employee Lookup

This site provides a form where you enter an FDA/HHS employees name and it provides their
location and contact information.

National Events Calendar - Medical Device Design (Registration Required)

Here, you select a month and find out what medical device design seminars, shows, conventions,
etc., are scheduled then.  You may submit your event here for inclusion in their database.

FDA Video Conference Schedules

Fairly self-explanatory, this site provides schedules for FDA's live video conferences.

Medmarket.com

Links to regulatory-related internet sites.

UCI Extension's Certificate Programs for the Life Sciences Industry

Medical Product Development
Clinical Trials: Medical Device and Drug Development>

Journal of Medical Device Regulation (JMDR)

Master of Science (Regulatory Science) at University of Southern California

Stand-alone courses and MS preparation in Regulatory, Clinical and Quality fields

MASTER OF SCIENCE IN REGULATORY AFFAIRS
Offered by SAN DIEGO STATE UNIVERSITY:

This degree program will provide a comprehensive background in regulatory science with the additional training and experience required of regulatory affairs professionals to address federal and state regulatory statutes and laws with emphasis on the Food and Drug Administration. The degree is offered through the collaboration of the College of Sciences and the College of Business Administration.

PharmedOut - Free CME

PharmedOut is an independent project run by physicians for physicians and other prescribers. Our goal is to disseminate information about how pharmaceutical companies influence what we prescribe, to increase access to unbiased information about drugs, and to encourage physicians to choose pharma-free CME.

Back to List

DRUGS:

FDA Center for Drugs Evaluation and Research

ISPE - International Society for Pharmaceutical Engineering
LA Chapter

PharmedOut - Free CME

PharmedOut is an independent project run by physicians for physicians and other prescribers. Our goal is to disseminate information about how pharmaceutical companies influence what we prescribe, to increase access to unbiased information about drugs, and to encourage physicians to choose pharma-free CME.

Back to List

DEVICES:

Link to MDD, AIMDD and IVDD

Links to the MDD, AIMDD and IVDD while the "implementation" link provides access to implementing
legislation, MEDDEVs and a host of other related information.

FDA Center for Devices and Radiological Health

Medical Device Link

Medical Device Link provides news and information for people who design, manufacture, and market
medical devices.

FDA CDRH Device Advice

CDRH self service medical device and radiation emitting product information.

FDA CDRH Referral

A kind of CDRH phone book related to and sorted by medical device area of interest.

Industry Organizations of Interest to Medical Device Manufacturers

Back to List

BIOLOGICS:

FDA Center for Biologics Evaluation and Research

Southern California Biomedical Council

SoCal Biomedical Council

SoCal Biomedical Council is the regional life science organization (OC-based LINC merged
with SoCalBio last fall and so we continue to have bimonthly meeting here in OC)

Back to List

QUALITY:

American Society for Quality

Process Industry Supplier Directory

Online searchable directory of process suppliers enabling buyers to easily source
manufacturers of process, energy and greater manufacturing products such as valves,
pumps and strainers. Site includes free magazines, jobs, news and events.

Back to List

STANDARDS:

IEC and Related Standards

The "Web Store Search" at the top right is a great way to find IEC and related standards.
The site even offers previews of the first few pages of each standard.

ISO Standards

To limit search to ISO standards be sure to change "All" to "Standards" before hitting "go" to
start the search.

ISO Support Group

On-line resource to assist in the implementation of ISO 9000, QS-9000 (including the
Tooling and Equipment Supplement of QS-9000), or ISO 14000.

National Standards Service

National Resource for Global Standards serves as a central point to search for standards information
from many sources.

American National Standards Institute

ANSI Online provides access to the latest national and international standards-related activities.

National Institute of Science and Technology

American Association for the Advancement of Medical Instrumentation

AAMI  standards on CD-ROM, AAMI directory of technology consultants, AAMI news, AAMI seminar
information and similar items of interest to regulatory professionals.

Back to List

Orange County Regulatory Affairs Discussion Group
 Kimberly Syre
 Attention To Detail
 5319 University Dr., Suite 641
 Irvine, CA 92612
 Tel: 949-387-9046
 Fax: 949-387-9047
 Email: ksyre@cox.net