Workshop on FDA Inspection by Madeline Ducate
On Thursday, 26th July 2018 a workshop on FDA Inspection was conducted at Jetwing Colombo Seven.
The event was organized by the Compliance and Quality Assurance team of RemediumOne and consisted of two sessions which constituted the topics of why FDA inspections are conducted and how to prepare for one. An event for invitees only, Principal Investigators of study sites that could potentially face an FDA inspection and Project and Study Leads of the same attended assuring their dedication and support in preparation for a potential FDA inspection for their sites.
The workshop was conducted by Madeline Ducate, a retired consultant with professional experience in FDA inspections. With hands on experience designated in the most recognizable positions with clinical research giants such as PharmOlam and PPD to name a few, Madeline was the perfect mentor in order to help us prepare should an FDA inspection be conducted at Sri Lankan study sites. During her visit to Colombo, Madeline also visited sites that could potentially face an FDA inspection and conducted mock inspections for the site teams at Colombo South Teaching Hospital for DEN-301 study and Lady Ridgeway Hospital for the MK 170 9274 study.
Having had the pleasure of being trained by a highly experienced consultant for FDA inspections we are confident that we would be able to apply her vast knowledge and appreciated advice should we face one in the near future.