Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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WEBINAR - Global Supply Chain Challenges: Impact on Drugs and Medical Devices
Wednesday, December 8, 2021, 8:00 AM until 10:00 AM
Link will be emailed to attendees 2 days prior to the meeting, or the night prior if
registering closer to the event
Registration is closed
RSVP by 6:00PM Tuesday, Dec 7, 2021
Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.
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PAID FEES ARE NON REFUNDABLE.
For webinar events, payment is REQUIRED at the time of registration.
TOPIC: Global Supply Chain Challenges: Impact on Drugs and Medical Devices
TOPIC DESCRIPTION: The panel will discuss the global supply chain challenges for drugs and medical devices particularly in light of the COVID-19 pandemic. What is the impact on the known supply chain challenges? How can companies approach capability, capacity, demand, allocation, sourcing, and supplier selection strategies? We will discuss how these topics are affecting pandemic-related products and emerging clinical treatments, particularly cold-chain supply issues for vaccines and biologics. Understand how these issues tie into the existing long-term impacts of accelerated overseas agency enforcement and how to apply risk management principles at the business and QMS levels to better manage what we can.
SPEAKERS: Christine Zomorodian, Colleen Clark, and Janet Rose Rea
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
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification
All attendees must be registered. Access to education content is a benefit of membership or guest attendance. The link to the webinar is intended for the registered person ONLY and any access/distribution of materials beyond the individual registrant is strictly prohibited. Viewing rights are not transferable and cannot be combined by multiple parties without express permission. Thank you for your understanding.
This webinar will be recorded.