FDA Manufacturing Compliance and Training Expert

Expertise

• Former FDA Investigator.
• Technical writing to build and implement quality systems.
• Comprehensive audit and gap analysis.
• CAPA and FDA responses and complaints including: Investigations, resolution, root cause analysis, corrective action plans, preventative action plans and CAPA effectiveness resolution and documentation.
• Employee training; laboratory and quality.
• Formal FDA Training in multiple program areas: Drugs; medical devices; process validation; industrial sterilization; biologics; dietary supplements; food and feed.
• Ability to audit both process and laboratory.
• Laboratory Information Systems (LIMS).
• Experienced in medical technology hospital laboratories.
• Complaint handling software (Trackwise).
• Subject matter expert and principal internal quality auditor covering areas; processing, development and regulatory requirements.
• Environmental sampling; contamination and best practice for capturing a bacterial contaminate.
• Gap analysis requiring FDA 483 observations in quality systems investigation programs.
• New product labeling.
• Validation: Protocols and reports method, cleaning, facility,equipment validation, controlled materials, product testing, water testing, product release, stability testing, QC inspections, test work sheets, other quality related and product manufacturing process documentation for compliance.

Experience

Undisclosed Company, 2014 - Present

• Consultant for quality systems: cGMP Compliance in FDA/ISO; quality control in the areas of medical devices, drugs, dietary supplements, biologics, food and feed.
• Created the quality system including process SOP's, MDR (Medical Device Reporting), master batch record, risk analysis, design controls, regulatory required SOP's and all associated forms for medical device and OTC contract manufacturer.
• Created process validation and cleaning validation plans (OTC Contract Manufacturer).
• Trained employees including QMR and quality control unit.
• Created laboratory quality system including testing methods, reporting and documentation.
• Trained laboratory employees on system and testing methods.

Food and Drug Administration, Des Moines, IA, Investigator, 2009 - 2014

• Formally trained in several program areas including drugs; medical devices; process validation; industrial sterilization; biologics; dietary supplements; API's and food and feed and table eggs.
• Maintained a "Generalist" status while working in various inspections/investigations, benefited from keeping up with industry and regulatory changes.
• Involved in training new hires to prepare for and conduct inspections.
• Included in reviewing Firms' 483 responses along with the Compliance Department to determine adequacy, bringing about valuable knowledge of FDA's expectations.
• Possessing laboratory background, capable of inspecting both process and the laboratory.
• Reviewed product impact and risk assessment to determine resolution adequacy.
• Provided both routine and violative reports of inspection/ investigations to management, meeting applicable deadlines.
• Supported team members in quality related inspections/investigations as both a team member and Lead Investigator.
• Collected and prepared investigation/inspection evidence to support violative inspections for further review to obtain official action. This included written Affidavits.
• Requested as a team member or Lead Investigator for difficult or previously violative inspections and investigations.
• Established gap analysis requiring FDA 483 observations in quality systems investigation programs such as CAPA, Supplier Corrective Action Report (SCAR), OOS, deviation, product non-conformance, and process controls.
• Followed both paper-based and electronic quality systems navigating software used for CAPA, OOS, failure, product complaint, NCMR, and deviations such as Trackwise, LIMS etc. to ensure compliance to applicable regulations.
• Reviewed product impact and risk assessment to determine CAPA and resolution adequacy.
• Conducted inspections and investigations as lead Investigator providing guidance and logistics.
• Trained by FDA in environmental sampling to ensure route of contamination and best practice for capturing a bacterial contaminate.

Continental Manufacturing Chemists, Madrid, IA, Director of Quality, 2007 - 2008

• Designed, created and established a paper-based quality system for OTC drugs both animal and human.
• Conducted research and development for new product formulas.
• Designed, drafted and or revised QC laboratory procedures as well as all forms associated with each procedure to meet the FDA and USP expectations.
• Functioned as the SME in all areas of the quality system including quality control, sterility assurance, lab controls, microbiology, process and validation.
• Responsible for all stability studies, annual product review, management meetings and internal audits.
• Expanded the laboratory to include microbiology and environmental testing.
• Approved all labeling for new products.
• Managed external partners and sister contract manufacturers on behalf of clients to ensure compliance to multiple quality systems regulations.
• Provided routine trend reports of quality related investigations to management to ensure corrective action effectiveness.
• Determine effectiveness of quality programs and remediation efforts.
• Performed CAPA investigations, resolution, root cause analysis, corrective action plans, preventative action plans and CAPA effectiveness resolution and documentation.
• Extensive understanding and skills in drafting, reviewing and remediating batch records.
• Provided customers with an extensive support in establishing a compliant process for new products per the customer request.
• Subject Matter Expert and Principal Internal Quality Auditor with extensive quality audit skills in all areas of processing, development and regulatory requirements.
• Evaluated data associated with different types of validation protocols and reports method, cleaning, facility and equipment validation.
• Performed management operations of quality systems such as the review and approval of product batch records, testing procedures, test methods, manufacturing processes, validation protocols and reports, controlled materials, product testing, water testing, product release, stability testing, QC inspections, test work sheets and other quality related and product manufacturing process documentation for compliance.
• Performed internal and external quality systems audits of sister manufacturing facilities for cGMP, and cGLP processes for compliance products.
• Designed and drafted the Disaster Plan to provide to customers.

Honors & Publications

Credentials

Certifications

• FDA Level I Investigator
• FDA Medical Device Training
• FDA Drug Training
• FDA Process Sterilization Training
• FDA Process Validation Training (Drugs/Devices)
• FDA Table Egg Training (including Environmental Sampling)
• FDA Biologics Training
• FDA Food Training
• FDA API Training
• FDA Dietary Supplements Training
• FDA Medicated Feed/Tissue Residue Training
• FDA Law, Evidence Development, Safety
• Medical Laboratory Technologist, ASCP
• Kansas District Office Recall Training
• Kansas District Office International Inspection Training
• Kansas District Office Sample Collection Training
• Kansas District Office FD&C Law Training
• Kansas District Office Quality Management in the Investigations Branch
• Kansas District Office Import Training

License

• American Society of Clinical Pathologists (A.S.C.P.)

Awards

• Leveraging and Collaboration Award - Investigation of Salmonella in Sprouts.
• Kansas City District Investigations Branch Recognition Award for exemplary performance in protecting the public from unsafe products
• Received 2 Warning Letters as a result of Investigation during a tissue residue Investigation, following the drug to the feed manufacturer. This investigation was utilized in a Kansas District Training.

Education

• A.A.S. Medical Laboratory Technology, Des Moines Area Community College, Ankeny, IA