Mr. Kenneth W. Schawel

Ken Schawel Consulting

22847 N. Ramsey Rd
Rathdrum ID, 83858

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Expert in Pharmaceutical and Device GMPs and sterilization.
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SUMMARY EXPERIENCE Over thirty-five years hands on experience in Pharmaceutical, Device and Biologicals Manufacturing in the area of small and large volume injectables, sterile medical sets and devices, tablets and capsules, and home health care. Specific expertise in aseptic fill, terminal sterilization, validation, GMPs, quality systems, new product development, and pharmacy compounding. Created and renovated numerous quality systems to meet FDA requirements during consent decrees, and establishment of new manufacturing plants and new manufacturing lines. CONSULTING EXPERIENCE EXAMPLES (1991-2000) Unites States Surgical Corporation-manufacturer of surgical staples and surgical devices Alcon Laboratories-manufacturer of ophthalmic solutions and devices Lyphomed(Fugisawa Corp.)-manufacturer of generic and proprietary drugs Puritan-Bennett-manufacturer of electronic monitoring devices Telios Pharmaceuticals-manufacturer of wound healing systems Novo Nordisk-world wide biotechnology company and major producer of insulin Alza Corporation-pharmaceutical manufacturing corporation Holister Stier Corporation- Small volume parenterals and biologicals Centeon Corporation-biological manufacturing Taylor/Acorn Pharmaceuticals-small volume parenteral contract manufacturer Due diligence of small volume parenteral manufacturing plant for possible purchase by client Due diligence of drug repackager in Russia for possible purchase by client GMP audit of R&D organization of a medium size biotechnology company Laboratory validation program for eye wash company CONSULTING PROJECTS -Rebuilt QA/QC system for medical devices -Provided QA/QC input during consent decree and evaluated and provided summaries for compliance issues. Evaluated validation system with proposed changes. Critiqued hundreds of batch records with appropriate changes proposed. -Trained QA/QC group in sterilization and GMP issues -Rebuilt complaint system and product change and evaluation system for device manufacturer -Responsible for validation of new large volume parenteral filling line for ophthalmic manufacturer. -Established QA/QC and validation system for several start-up corporations. -Responsible for validation of aseptic filling line for international corporation. -Auditing of laboratories, QA/QC systems and manufacturing facilities and systems. EXPERIENCE Biomedex (8/00 to 8/15/03) -Responsible for creating the Quality System for a clinical injectable manufacturing and device manufacturing company. -Developed aseptic fill programs and parts cleaning and assembly programs for clients. -Responsible for Quality Assurance, Quality Control, and Regulatory Compliance . -Key technical liaison for customers and investors. -Created FirstPharma, a compounding pharmacy Lyphomed (1988-1991) VP of QA/QC -Re-established FDA compliance and evaluated all ANDAs while under a consent decree. -Standardized all QC operations between three manufacturing facilities. -Managed a budget of 5-8 million dollars. -Established a corporate QA group group for R&D new product evaluation and approval. -Established a standard validation program for all facilities. CONSULTING (1986-1988) EXPERIENCE Caremark, Inc.(1982-1986) Director level technical position -Developed a patented aseptic fill manufacturing system for producing sterile customized TPN solutions in nationwide pharmacies -Responsible for a joint venture to produce sterile I.V. bags. -Technical expert for the company in manufacturing, laboratories, quality control, and regulatory compliance. -Developed and built a small R&D laboratory. -Participated in sales growth of 4 million dollars to 180 million dollars during my four years of employment. -Responsible for 30 facilities nationwide. Director level position. American McGaw Laboratories (1975-1982) Direct level QA/QC position -Succeeeful in establishing FDA compliance at a large volume parenteral plant in Georgia after an FDA initiated recall and shutdown. -Relocated to Irvine, CA divisional headquarters to takeover and reorganize the divisional quality assurance group. -Responsible for for direct approval of all manufacturing , engineering, and R&D programs. Abbott Laboratories (1968-1975)-Manager level QA/QC position -Was one of the key individuals in a plant start-up effort after an FDA initiated recall and shutdown . - Was involved in new plant start-ups in Rocky Mount, N.C.,(LVPs and SVPs)Laurinburg, N.C.(sterile disposable set manufacturer), and Alta Vista, VA(producer of sterile irrigating solutions). -Worked as QA troubleshooter for all Abbott divisions-hospital products, chemicals, pharmaceutical products, and diagnostics. Education M.S. and B.S. in microbiology with a minor in chemistry. Have completed numerous courses in business and management. Have taught general microbiology, sterilization, and aseptic fill courses. Have given numerous papers at professional seminars. Schedule of Fees for Expert #12394 Expert Designation Fee------------------$1000.00 (amount charged to use expert's name,applied to case) Retainer Policy-------------------------$4000.00 (applied toward last invoice) Non-Testimonial-------------------------$300.00 per hour (Consulting and Analysis) Testimonial-----------------------------$300.00 per hour (Deposition and in Court; Waiting to Testify) Travel Policy---------------------------$300.00 per hour for one way Misc------------------------------------At cost and as needed
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