Dave Ereth Email & Phone Number

Vancouver, Wa, Us

Consultant for the Pharmaceutical, Medical Device and Nutritional industries.

Remediation engineer for a Boston CMO pharmaceutical group working on Deviation investigations, CAPA, change control and developing engineering runs based on needs expressed by investigations/change control items.

Validation Lead for clean utilities (RODI, Clean Steam, WFI, etc.) for a new filling line under Operation Warp Speed

Interim Quality Manager for Document Control and Change Control systems for a Central California based nutritional company. This included obtaining new hires, developing labor standards and initial metrics.Developed and researched approximately 15 electronic Quality Management Systems for the site and provided proposals fro purchase, including multiple demonstrations by the QMS developers.

Consultant and trainer for Investigations & CAPA, HACCP for manufacturing areas and general QA consulting.Created Investigations and CAPA training for site staff, including mentoring and eventual scoring of investigations to increase staff capability due to warning letter. Also facilitated Hazard Analysis and Critical Control Point sessions for microbial control in manufacturing areas, as well as providing general QA guidance for Systems improvements.

Lake Forest, Il, Us

Performing validation activities for plant utilities including HVAC, HEPAs, compressed air, nitrogen, WFI, clean steam and room construction build out certification.

Raygun Digital Artistry and Media Innovations, LLC specializes in the application of artwork via large format laser cutting & engraving technology. Raygun has an established niche from Fine Artists to Professional Designers, for beautiful, high end results in almost any material.

Validation activities for plant utility systems including compressed air, air dryers, nitrogen generation, clean steam and lead for consultant group.

Ann Arbor, Michigan, Us

Worked with electro-mechanical engineers to review, resolve and update CAPAs.

Process EngineeringValidationCAPA

Chicago, Us

Responsible for ensuring quality and regulatory compliance of Electronic Health Record (EHR) software products; Direct the site quality management system (QMS)Oversee quality-related communications and trainingPerform quality system audits and inspectionsOversee corrective action / preventive action (CAPA)Responsible for complaint handling proceduresOwn site quality objectives, metrics, reporting & proceduresDrive compliance to FDA Medical Device Data Systems (MDDS) rule

Consultant, Establishing Project Management Quality Policies & Procedures Hired to document and create a uniform system for the project management staff from soliciting trade bids through final billing, including job change orders.Creating policies and procedures for an expanding and growing commercial construction management firm. Observing and tracking Project Management processes used by the staff from project estimation, bidding and site management and creating "best practice" methods and implementing these in policies and procedures.Created 4 policies and training for the project managers and support staff including electronic trade bidding, electronic project management filing systems, project agreements and change orders for ongoing and final billing.

Revised or initiated Quality System programs for Exception (Deviation) Reporting, Investigations, CAPA, MRB, Management Review, and BPDR.Managed and maintained staffing for a group of up to 12 individuals with a variety of responsibilities including clinical process batch record issuance, review, approval and release, quality systems tracking, trending and reporting, raw materials disposition and release, Contract manufacturing quality oversight including, batch record review, deviation resolution, product approval/rejection and release of materials including devices and proprietary protein and small molecule materials.Developed headcount justification for ongoing changes in corporation and developing project schedules.Served as Quality Assurance role in validation for buildings and room, method development (R&D and QC), equipment, IND development, label development and third party manufacturing.Assisted with BLA submission, PAI inspection and subsequent 483 response.

Tempe, Az, Us

Hired to assemble bid packages, and oversee construction/repair for fiber optic signal regeneration huts in CA, AZ, NM and WY.Assembled bids for electric, alarm, concrete, back-up generator, and general contractor for approximately 20 sites in 4 states.Assembled a work schedule to complete most sites in 3 days or under.

Abbott Park, Illinois, Us

Corrective Action / Preventive Action ManagerAssisted in initial Division provided training for Nonconformity Exception Reporting (NER) database system, and assumed plant responsibility for training personnel, June 2003.Mentored supervisors in Quality systems, the analytical laboratory, and manufacturing, on investigations and on the process of writing investigations. Emphasis is placed on root cause analysis and answering future auditors questions prior to them being asked, October 2003.Initiated weekly corrective action planning sessions for repetitive issues, May 2004.

Abbott Park, Illinois, Us

Recruited to create a biological quality assurance program for a recently acquired medical device business by Abbott.Re-classified cleanroom to ISO Class 8 in January, 2002Initiated BQA program, including 23 new SOPs, forms and room maps. Hired first of two employees for projects. Includes establishment of initial budget and labor standards, January 2002. Program modeled using ISO 13485.Responsible for representing BQA program during audits by FDA and foreign regulatory agencies in regards to QSR (CFR 820), or applicable standards.Established validation packages for finished product testing. Includes pricing and qualification for outside laboratories to conduct bioburden, endotoxin, particle and bacteriostasis/fungistasis testing, March 2002.Established in house testing for compressed air (microbial, particle, chemical) and disinfectant purchase, with an annual savings of approximately $28,000, October 2002.Responsible for evaluation of sterility, packaging or particulate customer complaints on returned devices.Established BQA Microbiology training program and plant "Micro 101" for cleanroom personnel, January 2003.Initial program was projected to take 2 years with no budget or other personnel provided. After a non-satisfactory internal audit, two more personnel were hired as full time employees and the project was completed in 6 months and viewed as compliant by domestic and international regulatory groups.

Abbott Park, Illinois, Us

Recruited to lead four QA groups and a set of consultants in the North Chicago facility of Hospital Products (now Hospira) to organize, prioritize and lead program into being a proactive, rather than a reactive support group after Abbott reached a consent decree with the FDA.Established validation procedure for utilizing historical (retrospective) data.Obtained funding for HPD LIMS upgrade project in association with Corporate Engineering Division.Achieved record low numbers of open biological investigations in January, 2001.Requested to establish and manage Biological QA Services group in February, 2001 - In charge of protocol development and tracking, media run tracking, database development.Given responsibility for the microbiology ID group in March, 2001Managed 2 consultant groups for laboratory IQ/OQ packages and plant re-validation package.

Abbott Park, Illinois, Us

Responsible for the direction of the microbiology and incoming quality assurance laboratories, including testing for all incoming commodities, in-process and final products, including working with new and existing suppliers in becoming qualified suppliers or resolving non-conforming items.Directed $100,000 laboratory expansion project.Created Environmental Monitoring Program for $52 million dryer facility, and upgraded main plant Environmental Monitoring Program.Member of cooling water standardization team for four domestic manufacturing plants.Member of team to install Reverse Osmosis in same manufacturing plants.Managed microbiology and incoming quality assurance laboratories. responsible for incoming, in process, and final product assurance for $200 million in annual products.

Directed daily activities of chemical laboratory.Created database mass flow program for 90 MGD water treatment plant.Obtained approximately $500,000 in new lab equipment for ultra low level water analysis.Set up EPA compliance program for potable water, and land fill systems.Extensive RO, Demineralizer and other water treatment systems experience.

B.S., Microbiology

Education record