Fresh Air 2000 - Medical Gas Requirements

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U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Regulatory Affairs
Regional Small Business Assistance Offices

Present via Satellite Broadcast

Coordinates and Technical Information

"Fresh Air 2000 - Medical Gas Requirements"
March 15, 2000
1:00 - 5:00 p.m. Eastern time

Duane Sylvia, Consumer Safety Officer, FDA Center for Drug Evaluation and Research, will present an overview of FDA's medical gas requirements. Refer to the agenda for a listing of specific topics to be addressed. During the live, interactive program, viewers will have the opportunity to pose questions to Mr. Sylvia via telephone or fax.

Objectives:

Increase awareness of Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals as they apply to Medical Gas Industry
Ensure Medical Gas Industry takes appropriate action to establish effective controls, thus preventing regulatory problems when inspections occur
Provide working knowledge to FDA investigators to integrate in day-to-day inspections
Provide the same regulatory message, at the same time, to FDA and state regulators, and medical gas industry

Target Audience:

Medical Gas Industry
State regulators of medical gas industry
FDA regulators of medical gas industry: investigators, supervisors, compliance officers

Viewing the Program: The workshop is free of charge and open to the public, either through direct downlinking of the program or through attendance at one of the following FDA public meeting sites:

Workshop Address	Local Time	Registrar
SAN JUAN, PR FDA San Juan District Office 466 Fernandez Juncos Avenue San Juan, P.R. 00901	2 p.m. to 6. p.m. Atlantic time	Daniel Gonzalez Director, Compliance Branch FDA San Juan District Office 466 Fernandez Juncos Avenue San Juan, P.R. 00901 (787) 729-6894 fax: (787) 729-6658 e-mail: dgonzale@ora.fda.gov
AUGUSTA, ME Maine Department of Agriculture Agricultural Building 333 Cony Road Augusta, ME 04330	1 p.m. to 5 p.m. Eastern time	Becky Maxim Consumer Safety Officer FDA Capital West Business Center 81 Leighton Road, Suite 14 Augusta, ME 04330-9303 (207) 622-8268 ext. 13 fax: (207) 622-8273 e-mail: rmaxim@ora.fda.gov
WINCHESTER, MA FDA/Winchester Engineering and Analytical Center 109 Holton Street Winchester, MA 01890	1 p.m. to 5 p.m. Eastern time	Herman Janiger Small Business Representative FDA Northeast Region 158-15 Liberty Avenue Jamaica, NY 11433-1034 (718) 662-5618 fax: (718) 662-5434 e-mail: hjaniger@ora.fda.gov
PHILADELPHIA, PA FDA Philadelphia District Office Room 900 U.S. Customhouse 2^nd and Chestnut Streets Philadelphia, PA 19106	1 p.m. to 5 p.m. Eastern time	Anitra Brown-Reed Public Affairs Specialist FDA Philadelphia District Room 900 U.S. Customhouse 2^nd and Chestnut Streets Philadelphia, PA 19106 (215) 597-4390 ext. 4548 fax: (215) 597-4660 e-mail: abrown2@ora.fda.gov
PITTSBURGH, PA U.S. Department of Energy Federal Energy Technology Center 626 Cochrans Mill Road Pittsburgh, PA 15236-0940	1 p.m. to 5 p.m. Eastern time	Cynthia L. Rakestraw Supervisory Investigator FDA Pittsburgh Resident Post 7 Parkway Center Room 390 Pittsburgh, PA 15220 Ph. (412) 644-3394 fax: (412) 644-5496 e-mail: crakestraw@ora.fda.ora
BALTIMORE, MD FDA Baltimore District Office 900 Madison Avenue Baltimore, MD 21201 The National Research Colon Energy Center Assembly Room A Edansdale Campus of West Virginia University Morgantown, WVA 26506 State Employees Office Building 201 W. Preston St. L-1 Lobby Conference Room Baltimore, MD 21201 State Department of Health 1500 East Main Street Richmond, VA 23218	1 p.m. to 5 p.m. Eastern time	Valerie Matthews Public Affairs Technician FDA Baltimore District 900 Madison Avenue Baltimore, MD 21201 (410) 962-3396 ext. 111 fax: (410) 962-0044 e-mail: vmatthe1@ora.fda.gov
ROCKVILLE, MD FDA Parklawn Conference Center 3^rd floor Rooms G and H 5600 Fishers Lane Rockville, MD 20857	1 p.m. to 5 p.m. Eastern time	Erik Henrikson FDA Center for Drug Evaluation and Research (HFD-320) 7520 Standish Place Rockville, MD 20855 (301) 827-0072 fax: (301) 594-2202 e-mail: henriksone@cder.fda.gov
CINCINNATI, OH FDA Cincinnati District Office 6751 Steger Drive Cincinnati, OH 45237	1 p.m. to 5 p.m. Eastern time	Mary Jane Jeffries Assistant to District Director FDA Cincinnati District 6751 Steger Drive Cincinnati OH 45237 (513) 679-2700 ext. 115 fax: (513) 679-2771 e-mail: mjeffrie@ora.fda.gov
MAITLAND, FL FDA Florida District Office 555 Winderly Place, Suite 200 Maitland, FL 32751	1 p.m. to 5 p.m. Eastern time	Frank Goodwin Public Affairs Specialist FDA Florida District Office 555 Winderly Place, Suite 200 Maitland, FL 32751 (407) 475-4707 fax: (407) 475-4768 e-mail: fgoodwin@fda.ora.gov
ATLANTA, GA FDA Atlanta District Office 60 8^th Street NE Atlanta, GA 30309	1 p.m. to 5 p.m. Eastern time	Teresa Thompson Supervisory Consumer Safety Officer FDA 2302 West Meadowview Road Suite 203 Greensboro, NC 27407 (336) 333-5419 fax: (336) 333-5563 e-mail: tthompso@ora.fda.gov
DETROIT, MI Kresege Auditorium 2nd Floor Harper Hospital 3990 John R. Detroit, MI 48201 *Attendance limited to one person per company	1 p.m. to 5 p.m. Eastern time	Evelyn DeNike Public Affairs Specialist FDA Detroit District 1560 East Jefferson Avenue Detroit, MI 48207-3179 (313) 226-6260 ext. 149 fax: (313) 226-3076 e-mail: edenike@ora.fda.gov
NASHVILLE, TN FDA Nashville Branch 297 Plus Park Boulevard Nashville, TN 37217	12 noon to 4 p.m. Central time	Kari Norton Consumer Safety Officer FDA Nashville Branch 297 Plus Park Boulevard Nashville, TN 37217 (615) 781-5388 ext. 112 fax (615)-781-5383 e-mail: knorton@ora.fda.gov
CHICAGO, IL FDA Chicago District Office 300 South Riverside Plaza, Suite 550 South Chicago, IL 60606	12 noon to 4 p.m. Central time	Patricia Lewis FDA Assistant to District Director FDA Chicago District 300 South Riverside Plaza Suite 550 South Chicago, IL 60606 (312) 353-7379 fax: (312) 886-3280 e-mail: plewis@ora.fda.gov
MINNEAPOLIS/ST. PAUL, MN Fort Snelling Room 196 1 Federal Drive Fort Snelling, MN 55111	12 noon to 4 p.m. Central time	Carrie Hoffman Compliance Officer FDA Minneapolis District 240 Hennepin Avenue Minneapolis, MN 55401 (612) 334-4100 ext. 159 fax (612) 334-4142 e-mail: choffman@ora.fda.gov
LENEXA, KS FDA Kansas City District Office 11630 W. 80^th Street P.O. Box 15905 Lenexa, KS 66285-5905	12 noon to 4 p.m. Central time	Tywanna Paul Public Affairs Specialist FDA Kansas City District 11630 West 80^th Street Lenexa, KS 66285-5905 (913) 752-2141 fax: (913) 752-2111 e-mail: tpaul@ora.fda.gov
NEW ORLEANS, LA FDA New Orleans District Office 6600 Plaza Drive, Suite 400 New Orleans, LA 70127	12 noon - 4 p.m. Central time	Kari Norton Consumer Safety Officer FDA Nashville Branch 297 Plus Park Boulevard Nashville, TN 37217 (615) 781-5388 ext.112 fax (615)-781-5383 e-mail: Knorton@ora.fda.gov
DENVER, CO FDA Denver District Denver Federal Center Building 20 6^th & Kipling Streets Denver, CO 80225-0087	11 a.m. - 3 p.m. Mountain time	Virlie Walker Public Affairs Specialist FDA Denver District Federal Center Building 20 6^th & Kipling Streets Denver, CO 80225-0087 (303) 236-3018 fax: (303) 236-3551 e-mail: vwalker@ora.fda.gov
DOWNEY, CA The Gas Company Energy Resource Center 9240 East Firestone Boulevard Downey, CA 90241	10 a.m. to 2 p.m. Pacific time	Virgilio Pacio Consumer Safety Officer FDA 4510 Executive Drive Suite 225 San Diego, CA 92121 (858) 550-3850 ext. 116 fax: (858) 550-3860 e-mail: vpacio@ora.fda.gov
BOTHELL, WA FDA Seattle District Office 22201 23^rd Drive SE Bothell, WA 98021-4421 Federal Emergency Management Agency Federal Regional Center 130 228th St S.W. Bothell, WA 98021-9796	10 a.m. to 2 p.m. Pacific time	Connie Rezendes Consumer Safety Officer FDA Seattle District 22201 23^rd Drive SE Bothell, WA 98021-4421 (425) 402-3178 fax: (425) 483-4996 e-mail: crezende@ora.fda.gov
ALAMEDA, CA FDA San Francisco District Office 1431 Harbor Bay Parkway Alameda, CA 94502	10 a.m. to 2 p.m. Pacific time	Steven Gillenwater Consumer Safety Officer FDA San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502 (510) 337-6802 fax: (510) 337-6702 e-mail: sgillenw@ora.fda.gov
New York City/Jamaica, NY FDA Northeast Region 158-15 Liberty Ave. Jamaica, NY 11433-1034	1 pm -5 pm Eastern time	Herman Janiger; FDA Northeast Region; 158-15 Liberty Avenue; Jamaica, NY 11433-1034 telephone: (718) 662-5618 and fax: (718) 662-5434
OREGON MT. HOOD COMMUNITY COLLEGE 26000 S.E. STARK ST., BOB SCOTT ROOM GRESHAM, OR 97030	10 pm - 2 pm Pacific time	Connie Rezendes Consumer Safety Officer FDA Seattle District 22201 23rd Drive SE Bothell, WA 98021- 4421 (425) 402-3178 FAX (425) 483-4996 e-mail: crezende@ora.fda.gov

Space is limited at the FDA public viewing sites, therefore interested parties are encouraged to register early. If you need special accommodations due to a disability, please inform the registrar for your site at least 7 days in advance of the workshop.

Those who will downlink the program to their own locations and who will not attend one of the FDA public sites do not need to register with the FDA in advance. Satellite coordinates and technical information will be posted on the FDA web site. Coordinates will not be available until 2-3 weeks prior to broadcast. Questions regarding satellite downlinking prior to day of broadcast should be directed to the Satellite Voicemail Line at (301) 594-2263.

Handouts/References: In preparation for this program, all viewers are encouraged to download from the FDA Compressed Medical Gas web site at http://www.fda.gov/cder/dmpq/gases.htm the following documents, and bring them to the viewing site on the day of the program:

(1) Fresh Air 2000 (3/8/2000)

(2) Title 21 CFR211, Current Good Manufacturing Practice for Finished Pharmaceuticals

(3) GMP Notes (Gas What?)

(4) Sample Batch Production Record

(5) Fresh Air: A Look at FDA’s Medical Gas Requirements, Duane Sylvia [HTML] and [PowerPoint] (2/25/2000)

(6) Agenda (3/1/2000)

Those who view the program from their own sites are asked to download and complete the following forms to give FDA feedback on the effectiveness of this program:

(1) Evaluation form [Word97] or [Acrobat]

(2) Sign In Sheet

(3) Question Submission Form

Contact: Mr. Erik Henrikson, Center for Drug Evaluation and Research (HFD-320) Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855; (301) 827-0072, or e-mail to henriksone@cder.fda.gov

FDA/Center for Drug Evaluation and Research
Last Updated: March 08, 2001
Originator: OTCOM/DML
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