Chris Townsend

I specialize in providing consulting services encompassing audits, guidance, and 3rd party investigations to pharmaceutical, cell and gene therapy, and vaccine manufacturers in aligning with U.S. FDA regulations and guidance. My expertise ensures compliance and excellence in the industry.

Direct or Subcontract to Pharmaceutical Clients

• Data Integrity Analysis/Audits
• Laboratory Instrument Validation
• MES Configuration/Quality Reviewer
• Software QA/CSV Consultant

• Developed eCTD compliant licenses for US marketed vaccines for improved regulatory product life cycle management.
• Assembled composite licenses for several vaccine products; ensuring strategic alignment with ICH guidelines and regulatory expectations.
• Proactively assess the registered US manufacturing and testing procedures are current and aligned with the global master dossier.
• Prepared post-approval chemical and pharmaceutical manufacturing and control (CMC) submissions for CBER (FDA) consistent with regulatory strategy/guidance which required coordination with US and European project teams.

Paper to Glass transformation.

Software validation on enterprise-wide network system to meet Consent Decree commitments

Projects:
•Quality management software upgrade
•Electronic document management system utilizing Documentum
•SLC remediation for Quality Management.

oAuthored and executed test scripts for system, user acceptance and system reports
oPositive/negative system testing
oSAP interface
oCo-authored revisions for Master Test plan
oMapped system requirements to business process procedures
oFunctional collaboration with business units for user testing requirements
oFinal reviewer of testable requirements and executed scripts
oDrafted and resolved test exception and deviation reports
oRemediation of current systems to meet CFR 21 Part 11 requirements

• CGMP validation for installation and qualifications of analytical instrumentation, client servers and database applications in compliance with industry guidelines, internal policies and SOPs utilizing the system life cycle approach
• Created lock down computers for Part 11 compliant systems
• Knowledgeable in a wide array of computer models, operating systems, software, servers and accessories
• Oversaw system administration to automated liquid handlers, computer driven analytical equipment and their associated servers and automated backups
• Laboratoty equipment representative for federal and international regulatory agencies for inspections. Administered corrective actions and provided formal responses to audits and PAIs
• Oversaw and supervised technical support personnel and managed laboratory capital projects

• Trained staff on laboratory instruments and procedures
• Authored procedures for new instruments and updated existing procedures
• Assisted in internal and external regulatory audits
• Developed methods for NIR analysis
• Coordinated the relocation of the Sterile Pharmaceutical Testing Laboratory
• Assisted with instrument qualification to minimize laboratory downtime

• Conducted chemical analysis for product intermediates using: LC, GC, UV/Vis, FTIR, Autotirators, AA and wet analysis methods in accordance with cGMP

• Authored laboratory investigations

• Trained new hires

• Routinely conducted regular and emergency maintenance of laboratory equipment

• Shift Environmental and Safety Representative and Union Steward
  

• Operated, maintained and supervised the use of nuclear, biological and chemical detection and decontamination equipment and smoke generators

• Performed live nerve agent training and simulated hazardous conditions training