Chris Loder Email & Phone Number

Deerfield, Illinois, US

- Create and run the audit readiness program at the Drug Delivery and Penicillin manufacturing sites- Educate and train personnel on cGMP and regulatory compliance.- Perform daily inspections of manufacturing areas for compliance with cGMP and local procedures.- Pressure test quality systems to identify potential regulatory gaps and process improvements.

Lake Forest, IL, US

- Manage and run the field corrective action office, which included the coordination and executionof recalls.- Provide oversight over manufacturing sites to ensure compliance with FDA field alert reportingregulations.- Review and assess event escalation notifications to executive management.- Develops value-added metrics for the organization (including.

Lake Forest, IL, US

-Coordinate the receipt and investigation of product quality complaints and drug adverse events.-Ensure adverse drug experience reports are submitted to regulatory authorities within applicabletimelines-Develop and implement post-market tracking and trending of product quality performance anddrug safety-Ensure annual Periodic Drug Experience Reports.

- Review and approve RAM documentation - Manage RAM process to ensure risk documentation is completed on time and accurate - Manage SCAR records to ensure records are addressed on time. - Worked on RAM remediation project per response to FDA - TrackWise regional coordinator: Processing NSR requests and creating new master records - Managed and notified.

Lake Forest, IL, US

• Mange closure of Supplier CAPAs in response to findings of audits.
• Lead teams in execution of remediation efforts
• Review audits for compliance with company procedures and requirements
• Coordinate efforts to obtain an acceptable CAPA plan from suppliers
• Liaison between interdepartmental efforts.
• Update and Verify information contained within GSQ TrackWise database

• Monitor trends in data via statistical process controls and six-sigma to identify and correct potential problems in production.
• Wrote procedures on laboratory testing and quality system management, overall release of products and entering information into database.
• Perform Failure Analysis and CAPA on out of specification materials.
• Issue Certificates of Analysis and provide technical support to our clients.
• Assist with new product formulation by performing qualitative analysis of new products
• Scheduled and coordinated production to meet the shipping schedule with no delays.

• Maintain accurate and detailed records of activities in a laboratory notebook.
• Perform testing on raw materials per compendial and client provided specifications.
• Perform instrumental analysis including FTIR, UV-Vis, TOC, and Elemental Analyzer
• Review and issue change controls; reviewed and managed SOPs
• Entering documents into the system, reviewed the documents, managing the overall documents, changes of the documents and overall approval.
• Ensure compliance within laboratories with CFRs

• Supervise the compounding and processing of bulk medication.
• Maintain equipment and rooms in working order.
• Worked with the Quality Assurance to ensure compliance
• Schedule personnel to meet production requirements