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Today

WEBINAR - ORCA NW Audit Panel

When:

Wednesday, June 30, 2021, 8:00 AM until 10:00 AM

Where:

Link will be emailed to attendees 2 days prior to the meeting, or the night prior if
registering closer to the event

Event Contact(s):

ORCA Admin

Category:

Webinar

Registration is closed

RSVP by 6:00PM PST Tuesday, June 29, 2021

Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.

Please make sure that the following email address is in your Safe Sender list: mailer@mail2.clubexpress.com. System messages like meeting announcements, registration confirmations, webinar login instructions as well as certificates of attendance are sent directly from this email address.

You will receive an email 2 days prior to the meeting date with the webinar login instructions or the night prior to the meeting, if registering closer to the meeting date. If you don't receive the instructions within this time frame, please contact us at info@orcanw.org as soon as possible.

Capacity:

100

Active Member (Regular, Student, Government)

No Fee

Non-Member

$60.00

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The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
This webinar will NOT be recorded.

TOPIC: ORCA NW Audit Panel

TOPIC DESCRIPTION: An informal peer dialogue about what it is like to participate in an audit.

SPEAKERS: Christine Zomorodian, Colleen Clark, and Janet Rose Rea

SPEAKER BIOGRAPHY:

Christine Zomorodian is a consultant in biomedical industries with over 25 years experience and emphasis on quality systems, regulatory affairs, process assessment and improvement, program management, product development requirements, quality data and metrics, contamination management, and clinical skills.

Colleen Clark is a leader in the creation and execution of complex business development strategies emphasizing an agile and competitive supply chain, selecting partners, negotiating contracts, and developing international operating strategies to support emerging markets. She has experience in FDA and Global Harmonization Task Force (GTHF) compliance, CAPA, risk assessments and supplier quality.

Janet Rose Rea is a Clinical, RA & Q industry leader across broad product portfolios with depth, breadth and successful outcomes in regulatory and quality strategy focusing on biologics, biosimilars and pharmaceuticals; strategies for global product development (clinical, regulatory, drug supply) and compliance; clinical, regulatory and quality systems intelligence, gap analysis, and compliance assessments; and extensive domestic/international submissions and regulatory health authority interactions.

WHO: Clinical, regulatory, quality, manufacturing and legal

This event does not qualify for RAC points; no certificate of attendance will be provided.