Vice President and Chief Quality Officer
Institute for Transfusion Medicine
Hub Stage Session 4
Women in Supply Chain Fireside Chats
1. What are your current projects in the Supply Chain Space?
2. How are you leading your team to leverage innovation in line with regulations?
3. What are some of the biggest challenges you have faced in your current role within the supply chain?
Speaker 1: Karen, Giraudo, Global Product & Cost Account Lead, Pacira Pharmaceuticals
Speaker 2: Roxanne Tata, Vice President and Chief Quality Officer, Institute for Transfusion Medicine
11:30 AM Preparing & Training Staff for Qualification and Validation Inspections from Regulators to Avoid Fines, Penalties, and Damaged Products
Preparing & Training Staff for Qualification and Validation Inspections from Regulators to Avoid Fines, Penalties, and Damaged Products
Supply chain professionals have pressure to protect the payload, ensure plastic bags don’t shatter and that transition temperature is met and in alignment with regulatory requirements.
· Implement in house qualification training and validation product training
· Train new staff to be SME’s on regulatory audits and investigations on packaging qualification.
· Collaborate with packaging engineers internally and with consultants to qualify all products before shipping
· Align staff on standards fluctuations and capabilities of all shipments if exposed to potentially damaging temperatures