Function as Person-in-Plant for a supplementary packaging facility for a NDA product

Consulting in Quality Assurance, Compliance Remediation and Validation

Deviations & CAPAs associated with API manufacturing

Worked with client’s team to implement validation program for eight topical OTC product lines in preparation for an FDA inspection: designed templates for equipment and utility qualification; trained personnel on equipment validation concepts and writing IQs & OQs (compounding tanks & filling lines); designed validation documentation tracking matrix and validation master plan for qualification activities; consulted on process validation template; drafted change control procedure & forms;… Show more Worked with client’s team to implement validation program for eight topical OTC product lines in preparation for an FDA inspection: designed templates for equipment and utility qualification; trained personnel on equipment validation concepts and writing IQs & OQs (compounding tanks & filling lines); designed validation documentation tracking matrix and validation master plan for qualification activities; consulted on process validation template; drafted change control procedure & forms; generated first draft of DI Water System IQ. Show less

Translation of german documentation of centrifuge & 2-stage homogenizer into english and gap assessment of qualification documentation; writing IQOQ protocol for 2-stage homogenizer.

Process Validation Phase 1 (completed): Write exhibit batch records, exhibit batch protocols, associated change controls (Metric Stream), and placebo batch records (stability-indicating) based upon data provided by PRD/Tech Transfer team for an extended release encapsulated bead product. Phase 2: Execution of exhibit batches and protocols, write final reports, close open deviations. Project suspended due to technical complications with process.

Lead a team of consultants to assist a small dietary supplement start-up company to become cGMP-compliant to an OTC drug product standard. Activities included:Interviewing, hiring and developing Universal Nutrients' personnel to staff in-house validation departmentQualification of Purified Water System (ozone disinfection)Manage resources for new drawings (architectural, MEP, P&ID, AF&ID) program for newly acquired facility with older systems in place

Quality Documentation Process Flow & Critical Systems Release Pilot ProjectMedImmune, Frederick, MD (Oxford International) Oct 2013 – July 2014• Wrote Documentation & Disposition Process Flow Project Charter describing project, scope, deliverables, success criteria, milestones & schedule, resources, constraints, assumptions and basic planning.• Performed process-flow mapping (PFM) & Value-stream mapping (VSM) of QA documentation production and movement associated with tasks… Show more Quality Documentation Process Flow & Critical Systems Release Pilot ProjectMedImmune, Frederick, MD (Oxford International) Oct 2013 – July 2014• Wrote Documentation & Disposition Process Flow Project Charter describing project, scope, deliverables, success criteria, milestones & schedule, resources, constraints, assumptions and basic planning.• Performed process-flow mapping (PFM) & Value-stream mapping (VSM) of QA documentation production and movement associated with tasks supporting the batch disposition function for biopharmaceutical products using MS Visio. Scope included generation of Master Production Records (MPR); generation of Batch Production Records; revisions to MPRs; QC & Micro test documentation & reporting; QC & Equipment Logbook System; and documentation production, processing and flow supporting Batch Disposition functions. • Wrote Documentation & Disposition Process Flow Pilot Plan to address several structural findings revealed during PFM & VSM activities. Pilot plan to be performed in parallel with current production processes in support of a 3-fold increase in commercial production for the year.• Assisted QA management with personnel and documentation flow planning associated with a construction project for a new Documentation and Disposition Center. Show less

Quality Assurance Consulting for a small facility. General quality and engineering activities to support the installation and qualification of a pharmaceutical site, including making revisions to Validation Master Plan, writing justification papers (utilities), writing Site Master File, writing and resolving open change controls, writing CAPAs, writing SOPs, and creating engineering documentation (Instrument Lists, Turnover Packages, URS), etc.

Wrote Problem Reports (PRs) for utility equipment (UPS, HVAC, WFI, Chilled Water Supply, etc.). Investigated deviations from process and support parameters for report: interviews, collection of documentation, review and analysis of data. Wrote Initial Impact Assessment, Interim Impact Assessment, Final Impact Assessments, performed historical reviews for related incidents in TrackWise, wrote Investigation Analysis, Investigation Findings, worked with Utilities Department personnel to… Show more Wrote Problem Reports (PRs) for utility equipment (UPS, HVAC, WFI, Chilled Water Supply, etc.). Investigated deviations from process and support parameters for report: interviews, collection of documentation, review and analysis of data. Wrote Initial Impact Assessment, Interim Impact Assessment, Final Impact Assessments, performed historical reviews for related incidents in TrackWise, wrote Investigation Analysis, Investigation Findings, worked with Utilities Department personnel to establish appropriate Corrective and Preventive Actions (CAPAs), and wrote Summary and Conclusion. Show less

Wrote Technical Reports: Recommended Instrument Attributes for production equipment (Cell Culture, Purification, Media/Buffer Prep, Warm/Cold Rooms). Investigated process parameters for technical report: collection, review and analysis of data; assisted team of consultants (2) collecting data and writing reports. Reviewed production records and manufacturing records, eliciting instrument-related process data points; collected these points to determine process requirements for each instrument… Show more Wrote Technical Reports: Recommended Instrument Attributes for production equipment (Cell Culture, Purification, Media/Buffer Prep, Warm/Cold Rooms). Investigated process parameters for technical report: collection, review and analysis of data; assisted team of consultants (2) collecting data and writing reports. Reviewed production records and manufacturing records, eliciting instrument-related process data points; collected these points to determine process requirements for each instrument in the process (Process Range) and classification of criticality (Critical/Non-Critical/ Reference Only). In addition, technical report proposed adoption of Recommended Calibrated Range, Minimum Calibration Tolerance and Minimum Required Instrument Resolution. Delivered seven (7) technical assessment reports. Show less

Biotech: Quality review of validation protocols, execution of Buffer Prep IQ, writing of Media Prep OQ, resolution of outstanding items in executed Pharm Air IOQ, writing of final report with addendum & deviaitons.

Implement Document Control System for virtual local office for Chinese manufacturing facility

Validation documentation of medical device/tools

Dietary Supplement Manufacturer Quality Systems design & implementation project

Quality Assurance function for Validation of a new facility and equipment associated with a combination drug/device product.