{"abstract":"The Food and Drug Administration (FDA) is announcing a workshop on the FDA Quality System Inspection Technique (QSIT). The topics to be discussed include: The development of QSIT, compliance program and warning letter pilot, management controls, corrective and preventative actions, design controls, production and process controls, and industry perspective of QSIT. The purpose of this QSIT workshop is to increase understanding of QSIT in the medical device community. By explaining this new inspection technique, FDA intends to ensure that the medical device industry takes appropriate action to establish effective quality systems and to prevent regulatory problems when inspections occur. Date and Time: The workshop will be held on March 8, 2000, from 8:30 a.m. to 4:30 p.m. Location: The workshop will be held at the Condado Plaza Hotel, 999 Ashford Ave., San Juan, PR 00907. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) along with a registration fee of $125.00 to Jose P. Rodriguez, Director of Special Programs and Seminars, the Puerto Rico Manufacturers Association, P.O. Box 195477, San Juan, PR 00919- 5477, 787-759-9445, ext. 204, FAX 787-756-7670. The fee covers refreshments, organization and site costs, and materials. Space is limited; therefore interested parties are encouraged to register early. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please inform Jose P. Rodriguez (address above) at least 7 days in advance of the workshop. Contact: H. Gordon Cox, Supervisory Investigator, FDA San Juan District Office, 466 Fernandez Juncos Ave., San Juan, PR 787-729-6801.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2000/02/28/00-4662.html","cfr_references":[],"citation":"65 FR 10502","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":[],"dockets":[],"document_number":"00-4662","effective_on":null,"end_page":10503,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/02/28/00-4662.xml","html_url":"https://www.federalregister.gov/documents/2000/02/28/00-4662/medical-device-quality-systems-inspection-technique-notice-of-workshop","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-4662?publication_date=2000-02-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-02-28/00-4662/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":24,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-02-28/pdf/00-4662.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-02-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/02/28/00-4662.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10502,"subtype":null,"title":"Medical Device Quality Systems Inspection Technique; Notice of Workshop","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":65}