Research Connect: Clinical Trials Preparation for Regulatory Inspection and Audits – Best Practices – Nov. 23, 2022

Session Description

[fusion_builder_container type=”flex” hundred_percent=”no” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” overlay_color=”” video_preview_image=”” border_color=”” border_style=”solid” padding_top=”” padding_bottom=”” padding_left=”” padding_right=””][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ background_position=”left top” background_color=”” border_color=”” border_style=”solid” border_position=”all” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” center_content=”no” last=”true” min_height=”” hover_type=”none” link=”” border_sizes_top=”” border_sizes_bottom=”” border_sizes_left=”” border_sizes_right=”” first=”true”][fusion_text]Research Connect has scheduled a very special webinar on one of the most important regulatory topics for clinical trials, “Preparation for Regulatory Inspection and Audits”. We are delighted to have Flora Noitsis, one of the most knowledgeable experts in the field, help us dive though the regulatory inspections and share best practices. Flora has recently retired from Health Canada where she served as a Specialist & GCP Inspector. During her 30 years of service with Health Canada, Flora planned and conducted inspections and investigations of the compliance of sponsors, investigators and establishments within Canadian Good Clinical Practices regulations and guidelines. She is currently working as a Senior Associate, Operations & Compliance, at BioAcuity Consulting Inc.

Given the nature of this webinar we anticipate reaching full capacity, therefore, we encourage everyone to register as soon as possible. To facilitate an extensive and comprehensive Q&A session we encourage everyone to submit questions to RCSS@HHSC.ca by Friday Nov 11th.

About the speaker:

Flora Noitsis holds a Hons. BSc. in Microbiology and Biochemistry from the University of Toronto. She started her pharmaceutical career working with private pharmaceutical laboratory as a bench microbiologist and Quality Control person for several drug importing companies and represented them during Health Canada inspections. Flora started with Health Canada in 1991 with the Drug Compliance and Verification Unit and moved to the drug GMP inspection unit where for 17 years she inspected large companies manufacturing injectable, oral, topical, drugs for human and veterinary use for GMP compliance. In 2008 Flora moved to the Clinical Trial Compliance Program where she planned and conducted inspections and compliance verifications of sponsors, investigators and CRO establishments. She represented Health Canada on a PIC/s GCP joint inspection group which included inspectors from MHRA and the EU. Most recently, as part of Health Canada’s pilot project to modernize the Clinical Trial Compliance Program, Flora was assigned to conducting clinical trial inspections of bioequivalence studies which included both GCP and analytical results assessment. In May 2022 Flora joined BioAcuity Consulting Inc. which specializes in providing quality, compliance. regulatory affairs, and operations consulting services to GMP, GCP, GLP, and GPP regulated bio/pharmaceutical, medical device, natural health, and other related life sciences organizations and companies.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]