How to Manage Your Suppliers in China and India During the COVID-19 Pandemic – Webinar Recording/Transcript
The coronavirus outbreak is having a huge impact on global supply chains, APIs, and drug substances and products in India and China — the largest combined pharmaceutical and medical device markets in Asia
You still need to carry on with your routine business practices and expected audits during this time of uncertainty. And you need to maintain supply when it might be limited.
This presentation will lay out the steps you’ll need to take to tackle this pressing issue. To be most effective, you’ll need to secure your supply chain, prepare suppliers for inspections, implement best practices, develop appropriate quality agreements, track and ensure supplier CAPA closures, determine supplier compliance and inspection histories, implement supplier scorecards and learn how to avoid unpleasant surprises.
John McKay, CEO and Chief Compliance Officer with Q1 Associates LLC, will discuss best practices (GxP) and strategic tips to provide tips to meet your auditing and business needs amid the COVID-19 pandemic.
During this presentation, we will cover:
- Remote Audits/Desktop Audits: process and risk-based audit schedule and program
- PPE for Unavoidable Business Travel: roundtrip travel and onsite supplier needs
- Methods to Prevent Drug Shortages
- Quality agreements
- Supplier agreements
- Monthly supplier meetings
- Secondary and back-up suppliers
- Sourcing from several locations
- Supply chain planning, advanced orders, and forecasting
- CAPA for Suppliers to Implement
- Corrective Actions and Preventive Actions for suppliers
- Quality System updates for COVID-19
- Business continuity plans
- Checked and verified protective measures during manufacturing, packaging, and labeling
- Methods to protect packaged products from potential exposure
- Protective measures for supply chain
- Clinical trials protective measures
Implement GxPs when auditing your Asian suppliers and prepare for upcoming inspections during the COVID-19 crisis.
Meet Your Presenter
John McKay, CEO and Chief Compliance Officer, Q1 Associates LLC
John McKay, CEO and Chief Compliance Officer with Q1 Associates LLC, has 34 years of global executive and senior management experience. He’s worked with companies in the pharmaceutical, medical device, combination products, biotechnology, chemical, healthcare, energy, automotive, aerospace, and IVD industries. McKay brings his expertise in quality, compliance, regulatory affairs, operational excellence, manufacturing, auditing, reliability, supply chain management, and distribution. He has completed numerous GxP projects, audits, and operational excellence/ISO/QEHS implementations—and has worked extensively around the globe.
Who Will Benefit
- Quality (QA, QC)
- Operational Excellence
- Health and Safety (EHS)
- Regulatory Affairs
- Supply Chain Management
- Supplier Management; Purchasing
- Procurement; Clinical Affairs
- Clinical Operations
- Product Development
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May 29, 2020