Quality and Regulatory Compliance 
Serving the Pharmaceutical, Biotechnology and Medical Device Industry


Joe Cwiertniewicz, RQAP-GLP, ASQ CQA

(425) 844-9545 (PST / PDT)

Biography

Joe Cwiertniewicz is a quality and regulatory compliance consultant with over thirty years of experience in the FDA and OECD Good Laboratory Practice (GLP), Good Clinical Practices (GCP) and current Good Manufacturing Practices (cGMP) regulations.  He has held Director, Quality Assurance, Associate Director of Quality Assurance, Manager of Corporate Compliance, and Senior Compliance Specialist positions with leading pharmaceutical and biotechnology companies.  He has experience with laboratory auditing, document and database audits, computer validation, animal welfare, and facility qualifications.
His clinical experience includes study monitoring, clinical laboratory, clinical investigator and CRO auditing, clinical databases, safety monitoring, and report and document auditing.  

Highlights of Qualifications
  • Pharmaceutical/biotechnology professional with over thirty years of experience
  • Pharmaceutical/biotechnology quality and regulatory compliance consultant since 2001
  • Successful (no FDA-483 issued) audit of a newly constructed contract research facility
  • Four successful (no FDA-483 issued) audits of Fortune 50 pharmaceutical research facilities
  • Successful corporate partner audits of an early stage biotechnology firm
  • Experienced in analytical methods development and validation
  • Performed over 100 vendor, software developer, and contract research organization audits
  • Prepared responses and corrective actions for FDA-483s and Warning Letters
  • Conducted audits in North America, Europe, Asia, South America and Australia
  • Audits of clinical research sites and investigators, databases and reports
  • Hosted numerous Federal, State and client audits and inspections
  • Experienced writer, author and reviewer of standard operating procedures & technical documents
  • Lecturer on quality assurance and regulatory compliance topics
  • Adjunct faculty in Community College level Quality Control, Quality Assurance, Reliability
  • Certified Quality Auditor, American Society of Quality
  • Registered Quality Assurance Professional – GLP, Society of Quality Assurance
Preclinical Projects Performed Under Contract Include
  • Evaluation of in-house analytical and bioanalytical laboratories
  • Evaluation of contract toxicology, pathology, histology, and genetic toxicology labs
  • Evaluation of analytical, bioanalytical, and flow cytometry laboratories
  • Audits of contract facilities in the United States, Canada, Europe and Asia
  • Preparation and review of Standard Operating Procedures and regulatory documents
  • Assistance in preparing for audits for corporate sponsors
  • Investigation and remediation of problem studies
  • Quality assurance staffing support for staff on medical leave
  • Assistance to in-house Quality Assurance and technical staff in meeting project deadlines
  • Technical and regulatory training of quality assurance and technical staff
  • Preparation of responses to FDA-483 observations
  • Taught courses and seminars in GLP regulations and regulatory audits
  • Invited speaker for courses sponsored by RAPS (Regulatory Affairs Professional Society)
  • Special Session presentations on GLP regulations at AAALAS National Meetings
  • Participated in method transfer and technology transfer
  • Participated in the preparation for successful AAALAC facility inspections
  • Technical writing assistance for New Drug Applications and Common Technical Documents
Clinical Projects Performed Under Contract Include
  • Evaluation of clinical pathology and bioanalytical laboratories
  • Evaluation of contract research organizations and clinics
  • Evaluation of medical imaging centers and support facilities
  • Audits of clinical investigators in the United States, Canada, Europe and Asia
  • Database audits for accuracy and consistency
  • Assistance in preparing for audits for corporate sponsors
  • Investigation and remediation of problem studies
Manufacturing Projects Performed Under Contract Include
  • Evaluation of analytical and support laboratories
  • Evaluation of contract manufacturing facilities
  • Evaluation of API manufacturers, and fill and finish vendors
  • Audits of contract facilities in the United States, Canada and Asia
  • Preparation and review of Standard Operating Procedures and regulatory documents
  • Participated in method transfer and technology transfer of manufacturing processes
  • Investigation and remediation of problem
Services

Audits of Contract Research Organizations (CROs)
Pre-placement qualification audits to assist in vendor selection
Sponsor due-diligence monitoring and auditing of CROs
Auditing of data and draft reports
Due-diligence audits of ongoing studies
Investigation and evaluation of problem studies

Good Laboratory Practice Program Support
Evaluate programs and services
Gap analysis and recommendations
Document review for internal accuracy and consistency
Assist in developing systems and procedures
Train staff in quality practices and regulatory requirements

Good Clinical Practice Program Support
Pre-qualification and due diligence assessments of contracted services
Compliance audits of clinical investigators and pharmacies
Audits of support laboratories and analytical services
Pre-blind break audits of databases and adverse events
Document review for internal accuracy and consistency

Flexible Quality Assurance Unit Staffing and Program Support
Hands-on assistance with completing projects to meet deadlines
Auditing and inspecting of in-process activities
Reviewing and auditing of draft reports
Auditing of study records and raw data
Guidance in regulatory strategy   

Standard Operating Procedure (SOP) Development
Author or co-author SOPs
Provide assistance to your staff in SOP development
Staff training in writing effective SOPs
Provide expert review and editing of SOPs

Articles

To be added