[Federal Register Volume 68, Number 106 (Tuesday, June 3, 2003)]
[Notices]
[Pages 33162-33163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Drug Manufacturing Inspections; Public Workshops

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshops.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a series 
of public workshops to discuss current good manufacturing practice 
(CGMP) issues, including quality subsystems, areas of change control, 
and quality management. There will also be a discussion of current 
compliance issues and trends and the status of the part 11 (21 CFR part 
11) draft guidance. The first workshop will be held in June 2003, then 
repeated in July 2003 and August 2003 at different locations to enable 
as many people to attend as possible. Held in collaboration with the 
Consumer Healthcare Products Association (CHPA), the workshops are 
intended to update participants with respect to issues involving CGMP 
compliance. Participants will also hear from FDA and industry speakers 
on

[[Page 33163]]

specific topics related to methodologies and implementation of quality 
systems including areas such as global change control and corrective 
action preventative action (CAPA) investigations.

DATES: For the dates of the workshops, see table 1 in the SUPPLEMENTARY 
INFORMATION section of this document.

ADDRESSES: For the locations of the workshops, see table 1 in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Fred Razzaghi, Consumer Healthcare 
Products Association, 1150 Connecticut Ave. NW., Washington, DC 20036, 
FAX 202-223-6835, info.org">fred.razzaghi@chpa-info.org; info.org">http://www.chpa-info.org; or Erik N. Henrikson, Center for Drug Evaluation and Research 
(HFD-320), Food and Drug Administration, 11919 Rockville Pike, 
Rockville, MD 20852, 301-827-9004, FAX 301-827-8907, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Who Should Attend?

    This document is directed towards professionals involved in the 
manufacture, control, and regulation of pharmaceutical products. 
Examples of professionals who may be interested include process/
production engineers, quality assurance/quality control and regulatory 
affairs professionals, auditors, repackers and relabelers, consultants, 
regulatory investigators, CGMP compliance officials, and FDA center and 
field personnel. Other entities or individuals may also be interested 
in attending.

B. Where and When Will The Workshops Be Held?

    We have scheduled three workshops at different times and locations 
to enable as many people to participate as possible. Attendees can 
attend the workshop that is most convenient. The times and locations of 
the workshops are listed in table 1 of this document.

               Table 1.--Workshop Locations and Schedules
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            Workshop Location                      Date and Time
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Sheraton Meadowlands Hotel, Two           Monday, June 16, 2003, from
 Meadowlands Plaza, East Rutherford, NJ    8:30 a.m. to 5 p.m.
 07073, 201-896-0500, FAX 201-896-9696.
San Juan Marriott Resort, 1309 Ashford    Monday, July 14, 2003, from
 Ave., San Juan, PR 00907, 800-981-8546,   8:30 a.m. to 5 p.m.
 FAX 809-722-6800.
Hyatt Regency Chicago, 151 East Wacker    Tuesday, August 12, 2003, from
 Dr., Chicago, IL 60601, 312-565-1234,     8:30 a.m. to 5 p.m.
 FAX 312-565-2966.
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C. How Can I Participate?

    You can participate in person. Anyone interested in attending a 
workshop can register through the information contact.

D. Is There a Registration Fee for This Workshop?

    Yes, a registration fee of $ 320.00 is required. The registration 
fee includes workshop reference materials and lunch plus a continental 
breakfast and coffee breaks. Government employees qualify for a 
discounted rate of $75.

E. How Can I Get Additional Information?

    The notice of participation form, information about the workshop, 
and other related documents are available from the information contact 
or from the Internet at http://www.fda.gov.cder/workshop.htm.

II. Background Information

A. Why is FDA Cosponsoring These Workshops?

    FDA is cosponsoring this series of workshops to provide information 
and training opportunities for industry as well as FDA center and field 
personnel. The workshops are being scheduled for three different times 
and locations to enable as many participants to attend as possible.

B. What Will Be Covered?

    The workshops will provide an update on the progress of the 
agency's CGMP initiative, the status of the part 11 draft guidance, and 
the agency's progress in developing ideas about risk management 
associated with CGMP. In addition, FDA and industry speakers will 
present information and training on specific topics related to 
methodologies and implementation of quality systems in categories such 
as global change control and CAPA investigations. Presentations by both 
FDA and industry will provide a regulatory and practical perspective on 
the current relevant critical topics.

    Dated: May 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13756 Filed 6-2-03; 8:45 am]
BILLING CODE 4160-01-S