Course Description:
This interactive One and a half day course lead by FDA's recently retired CDRH Recall Branch Chief Rita Hoffman who has more than 36 years' experience in FDA compliance issues will provide the participants tools to minimize risk of regulatory enforcement actions.
During the seminar, she will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall. She will also discuss how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.
This interactive One and a half day course lead by FDA's recently retired CDRH Recall Branch Chief Rita Hoffman who has more than 36 years' experience in FDA compliance issues will provide the participants tools to minimize risk of regulatory enforcement actions.
During the seminar, she will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall. She will also discuss how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA.
