Tod E. Ransdell - TERA Validation

Tod E. Ransdell
13539 28 th Avenue NE
Seattle, WA 98125-3501
[206] 409-9793 (Home/Cell w/ Messaging)
eMail: todransdell@yahoo.com – TERAValidation@PugetReiki.org
Objective:
I believe that my extensive experience and in depth skill sets would be advantageous and
complimentary for filling either a consulting or full-time employed position in a Validation
(System/Equipment/Process), QA, or Regulatory Affairs Group within a progressive
Biotechnological, Pharmaceutical or Medical Device or Diagnostics (IVD) Company.
SUMMARY OF QUALIFICATIONS
Senior Specialist: 21 years experience in the field of Validation within the In Vitro Diagnostics,
Biotechnological, and Pharmaceutical (Parenteral) Industries
Compliance Auditor: Able to conduct thorough and accurate in technical reviews and audits for
internal, industry and federal regulatory compliance
Technical Writing: wide-ranging documentarian experience, including generating technical
documents, charts, graphs, and reports utilizing MS ® Excel 2000/XP, and MS ® Word for Windows ®
2000/XP, including other software in MS ® Windows ® 2000/XP native environments
RELEVANT SKILLS & EXPERIENCE
Independent Industry Consultant – TERA Validation
Validation Department Manager – New Facility Startup (New Product, Facility Expansions, Phase III
Pivotal Clinical Trials, etc.)
Senior Validation Specialist coordinating all validation activity at a multi-site (IVD) corporation
Board of Advisors and contributor for international technical journal (IVT)
Project Manager [Supervised up to 5 Engineers and/or Validation or Calibration Technicians]
Chairperson to a Cross-Functional, Director and Departmental Manager’s Validation Committee
Audit facilities for compliance with internal and external (cGMP) standards and procedures
Certified ISO 13485:2003 Internal Auditor
Technical Review and Execution of Software Qualification Protocols; HMI Commissioning
Preparation and implementation of protocols, procedures, and final reports
Cycle Development; temperature distribution, heat penetration and lethality studies
Validation/Qualification of pharmaceutical process equipment and systems including autoclaves, dry
heat ovens and tunnels, washers, lyophilizer (SIP), freeze drier, tanks, DI and WFI water systems,
distribution lines, clean steam systems, aseptic filling systems (fill accuracy), incubators,
environmental chambers and compressed gas systems
Steam-in-Place Sterilization of tanks, distribution lines and lyophilizers/freeze dryers
USP XXII through Current Purified Water and WFI testing; chemical and microbiological
Particle Testing [USP XXII procedure]
Validation of a new international facility (Great Britain-1990) following European Pharmacopoeia
criteria, British ‘Orange Book’, as well as U.S. Regulatory Guidelines
Calibration of pressure gauges, timers, temperature recorders and thermocouples, scales,
volumetric delivery devices, and humidity sensors
Particle counter calibration and resolution testing
Setup and performance of laboratory tests
RECENT EMPLOYMENT HISTORY
Current Sr. Validation Specialist TERA Validation (Consultant/Contractor)
2004 to 2005 Validation Department Manager Xcyte Therapies, Inc. Seattle/Bothell, WA
1999 to 2004 Sr. Validation Specialist Bio-Rad Laboratories, Redmond, WA
1993 to 1999 Sr. Validation Specialist Sanofi Diagnostics Pasteur, Inc./GSC, Redmond, WA
1992 to 1993 Sr. Validation Specialist Skyland Scientific Services, Inc., Bozeman, MT
1987 to 1992 Validation Specialist Skyland Scientific Services, Inc., Bozeman, MT
17 July, 2008 Tod E. Ransdell [1]

17 July, 2008 Tod E. Ransell [2]
EDUCATION AND TRAINING
Lab Technician (Work/Study), 1976, MSU Plant and Soil Science Department, Bozeman, MT
Bachelor of Science in Botany, 1977, Montana State University (MSU), Bozeman, MT
PDA Continuing Education Seminars:
HIAC/Royco Particle Counting System 1988
Steam-in-Place Sterilization 1988
LAL Technology and Workshop 1990
Viable and Non-viable Environmental Monitoring 1990
Pharmaceutical Water 1992
Validation Issues in Chromatographic Processes 1993
Downstream Purification of Proteins 1993
Chicago Conference Short Sessions 1994
Industrial Environmental Surveillance and Control 1995
Viable Environmental Monitoring (Advanced) 1995
Cleaning Validation 1996
Other Professional Courses and Seminars:
Qualification of Biotechnology Facilities, Systems and Processes;
Lease, Crutcher, Lewis Seminar; Presented by James Agalloco 1993
Control Systems Validation; Siemans Industrial Automation 1994
Hewlett Packard; Video-Teleconference;
Regulatory Compliance: Trends for the 90’s 1995
FDA Compliance Roundtable/Teleconference (ORCA) 1995
Training Dynamics, WBBA & Alliance for Biotechnology;
Validation Solutions: Practical Applications Seminar Series;
1] Cleaning Validation Programs ... 1995
2] Environmental Monitoring & Sampling ... 1995
The Dale Carnegie Course:
Improving Performance and Personal Effectiveness 1996
Introductory Design of Experiments (Logicon) 1998
Intermediate Design of Experiments (Logicon) 1999
ISO 9000 Internal Auditor Training (ETI Corp) 2000
Validator 2000 Training (Kaye Instruments) 2002
ISO 13485:2003 Auditor Training (TÜV/Canada) 2003
Leadership Development (AAFFOC) 2002/2003
Personal Mastery I and II (AAFFOC) 2002/2003
Conducting Gap Analysis of Validation Pgm. (IVT; Tele-seminar) 2004
The New Aseptic Guideline – Overview 2004
Aseptic Process Qualification (ORCA) 2006
PROFESSIONAL MEMBERSHIPS and APPOINTMENTS
Parenteral Drug Association, Inc. (PDA)
1993 to present
International Society for Pharmaceutical Engineering (ISPE)
1993 to present
The Organization of Regulatory and Clinical Associates (ORCA)
1994 to present
Washington ISO9000 Initiative 1994 to 1996
Board of Advisors of the Journal of Validation Technology
1996 to present
Institute of Environmental Science and Technology; Sr. Member
1998 to present
Institute of Validation (Great Britain) 1999 to 2003

17 July, 2008 Tod E. Ransell [3]
PUBLICATIONS and LISTINGS
“The Art and Science of Autoclave Validation”; Journal of Validation Technology; Vol. 2, No. 3, May 1996
“The Validation Dictionary”; Journal of Validation Technology; First Edition, 1997; 2 nd edit. 2002/2003
“Cost of Validation”; Journal of Validation Technology; Vol. 3, No. 2, Feb. 1997
“Establishing Effective Calibration Criteria”; Journal of Validation Technology; Vol. 4, No. 2, Feb. 1998
“Purified Water Systems: A System Perspective Under the New USP Quality Requirements”; Journal of Validation
Technology; Vol. 4, No. 4, Fall 1998
“Qualification of Environmental Chambers”; Journal of Validation Technology; Vol. 5, No. 2, Feb. 1999, pg.125
“Considerations in Reviewing Controlled Documents”; Journal of Validation Technology; Vol. 6, No. 4, Aug. 2000, pg.125
“Certification of Validation Professionals: Further Comments and Considerations”; Journal of Validation Technology; Vol. 7,
No. 3, May 2001, pg.269-271
Marquis Who’s Who in Science and Engineering; 2 nd Edition, 1994
LIFE INTERESTS and VOLUNTEER ROLES
Reiki Master; Usui System of Natural Healing (Takata>Ishikuro Lineage), initiated SEP 2000
Facilitator and Chairman for the Puget Sound Reiki Practitioners Circle; 2001-2004 (www.pugetreiki.org)
Beginners Seminar from Fungi Perfecti with Paul Stamets – Cultivation of Gourmet & Medicinal Mushrooms; JUN 2004
Wildcrafting and Urban Herbology (Permaculture) Seminar – with Michael Pilarski (Friends of the Trees Society); JUL 2004
Coordinator of the Facilities Development Task Force; the American Association for the Furtherance of Community; 2001
Department Manager of Householding and Land Stewardship; 2002-2004, (AAFFOC)
Treasurer of Convocation: A Church and Ministry; 2000-2001, 2004-2005 fiscal years (AAFFOC)