Chris Loder Email & Phone Number

Lake Villa, Il, Us

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 corporate and the sites)- Attends site management review/technical review board meetings for better insight of appropriatemetrics- Tracks audit observations (including Supplier Quality, Internal, and External Inspections)- Keeps abreast of current trends and developments in regulatory guidance- Provides ad-hoc data requests from Akorn and external systems and provides the information torelevant parties- Coordinates the acquisition of data and distributes to management and other relevant parties

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 (PADERs) were completed and submitted on time-Perform peer review of submissions and training as applicable.

- 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 individuals of unfavorable SCAR trends - Coordinated with multiple sites/functional groups to ensure compliance with CQPs

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.• Perform routine chemical analysis in support of production and R&D efforts

• 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• Manage and control documentation within laboratories• Audit laboratories and systems

• 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