Compliance Architects

Consulting Technology Outsourcing

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The core of CA’s best-in-class talent offerings is our proprietary, innovative life sciences quality skills inventory. Assessing competence in over 225 skill and capability areas, our skills inventory helps CA ensure we provide only the most outstanding consultants for your complex quality, regulatory, compliance, and operations needs.

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Results-driven quality management consultant and industry expert who translates vision and strategy into customer-oriented actions

Expert at: Medical devices, IVDs, implantables, quality system remediation, CAPA, complaints, MDR, MDV, device design controls, FDA inspection preparation and management, lean compliance, SOP design and development.

Highly skilled at: Pharmaceuticals, cosmetics, process optimization, quality system audits, verification and validation, mock inspections, due diligence.

Recent client projects:

  • Consulting, training, and audit support to achieve compliance with US FDA and global regulations.
  • Interim VP of quality.

Experienced quality control, research and analytical development professional and consultant

Expert at: Biopharmaceuticals, vaccines, medical devices, IVDs, quality control labs, data analysis, validation, transfer activities, OOS evaluation, CAPA, risk management, quality systems.

Highly skilled at: Lyopholization, gap analysis and QMS development, SOPs, guidance documents, and company policies to fill and eliminate gaps, QA support.

Recent client projects:

  • Interim QC Director.
  • SOP and training material development.
  • QC/method and equipment validation/transfer data review, protocols/reports.•Manufacturing & QC deviation report writing and resolution.
  • QC lab audits and assessments.

Senior consultant with extensive experience with US and EU cGMP, GCP, GLP and ICH requirements

Expert at: Pharmaceuticals, medical devices, biologics, inspection preparation, manufacturing engineering, validation, quality systems development, non-conformances, CAPA.

Highly skilled at: combination products, technology transfer, quality risk assessment and mitigation, statistical process control.

Recent client projects:

  • Quality and regulatory assessments of client studies, procedures, technology transfer projects, and programs to determine compliance.
  • Exception management system and implementing corrective/preventive action plans to address deficiencies.
  • Quality systems and validation programs – 15 month project with start-up pharmaceutical company with cleanroom and isolator technology developing several combination products. Conducted quality/regulatory compliance gap identifications and directed gap remediation efforts, preparing for the company’s pending PAI.
  • Multiple regulatory submissions for Class II and Class III Medical Devices.

QMS/technical consultant with expertise in technical services and quality systems support in drug/biologics manufacturing

Expert at: Pharmaceuticals, OTC, combination products (drug/biologics), aseptic processing/sterilization, cleaning validation, environmental monitoring, metrology/calibration, process validation, preventive maintenance, production process and controls, Risk Analysis / Risk Management, SOP Development and Implementation, Technical Transfer, Validation, water systems.

Highly skilled at: Cosmetics, biologics, lyopholization, packaging and labeling, quality system design.

Recent client projects:

  • End to End Assessment of Sterile Manufacturing Operations facility.
  • Quality Management System Assessment against FDA cGMP Guidance and USP. Developed a Corrective Action Plan of all activities to correct gaps.
  • Established Global Validation programs (policies and SOPs) for Process Validation and Equipment/Facility/Utility Qualification applicable to OTC manufacturing sites.
  • Remediation project for FDA Consent Decree.
  • Commissioning and qualification of equipment, facilities and utilities related to the move of an entire stability facility and labs from one location to another.

Experienced pharmaceutical industry professional highly skilled at establishing and rationalizing QMS

Expert at: Pharmaceuticals, CAPA/deviations/NCRs, contract manufacturing, quality assurance, 483/Warning Letter responses, audits/assessments/compliance strategy, document systems/control/administration.

Highly skilled at: Aseptic processing, lab controls, outsourcing, quality control.

Recent client projects:

  • Focused interactive training and learning workshops for entire facility personnel, including annual GMP training and facilitated others: deviations, non-conformances, investigations, CAPA, root cause analysis, batch record review/ change management systems.
  • Performed assessments, developed remediation plans, and supported implementation of quality management system enhancements for: training, investigations/deviations, change management, documentation management, CAPAs, customer complaints, manufacturing, packaging/labeling, analytical/microbiology testing, and distribution.
  • Supplier/vendor and CMO audits to support client management quality systems for solid oral and sterile products.
  • Interim QC Manager responsibilities for commercial sterile product operations.

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