Ziva Abraham
Ziva Abraham has over 25 years of academic, research, clinical and industrial experience in Microbiology, and Quality Assurance. She has trained personnel from various industries in microbiology techniques and methods. Ziva has received her Master’s Degree in Microbiology and has conducted research on developing Microbial Insecticides during her graduate studies working mainly with fungi. She has established clinical laboratory systems in Israel, and Microrite, Inc. a consulting company based in San Jose, CA that helps Pharmaceutical, Medical Device, and Biotechnology  Companies. Microrite focuses on helping companies with contamination control, microbiological quality control for sterile and non-sterile manufacturing, and Quality Assurance. Ziva has also developed “BACTISPELL” a microbiology spellchecker to spell check genus and species names of microbes and other microbiology related terms. She is a member of PDA, ISPE, AAMI, and PMF and is an active mentor for graduate students at Stanford University working through the American Woman in Science Organization (AWIS). She is involved in Expanding Your Horizons a program through the Math and Scientific Network to educate young girls about careers in science. Ziva served on the editorial board of Pharmaceutical Microbiology Forum (PMF) Newsletter.

Classes taught:
- Contamination Control in the Bioscience Industry: A Holistic Approach

Naomi Allen
Naomi Allan is an ASQ Certified Quality Auditor at PML Microbiologicals in Wilsonville, Oregon. As well as conduct internal audits, create and administer CAPA and Quality systems, she has designed, developed, and implemented training programs relating to quality in the biomedical field for college and corporate audiences for over fifteen years. Naomi is a member of the American Society for Quality, Oregon Bioscience Association and Phi Theta Kappa.

Classes taught:
- Executing Mock Audits and Preparing for Regulatory Inspections
- Overview of FDA Requirements for Regulated Industries: A Technical Track

 
Dave Benak
Dave Benak has 30-plus years of training and development experience as the Director of Training for an internationally known Fortune 500 Company.  He is a contributing writer to the Vancouver Business Journal.  For the past six years, he has owned and operated TrainingPays, a Vancouver-based training and development company.  He specializes in leadership, sales, management, and supervisory training as-well-as interpersonal skills, group facilitation, and platform skills.

Dave holds a BSBA degree from the University of San Fransico and has attended Columbia University in New York.  He teaches at both Portland Community College and Clark College in Vancouver.  His list of clients includes:  Xerox, Intel, Chief Executive Forum, The Management Group, Nautilus, and TriMet of Portland.  He has been a member of the American Society for Training and Development (ASTD) for over 25 years.

Classes taught:
- Enhancing Communication by Understanding Yourself and Others

Mark Biederbeck
Mark Biederbeck has more than 20 years experience in manufacturing including nearly 9 years as a consultant with the Oregon Manufacturing Extension Partnership (OMEP).  While with OMEP, he has worked with companies across a wide variety of industries facilitating more than 10 major Lean transformations and delivering more than 100 training events in various Lean topics. The results of these efforts have yielded increased capacities/sales, new and retained workers and dramatically reduced costs.  Although Mark is skilled in many aspects of Lean Manufacturing, he is particularly interested in seeing companies develop their own continuous improvement culture.  Recently, Mark achieved the Society of Manufacturing Engineer's Bronze Certification in Lean Manufacturing.

Classes taught:
- LEAN Value Stream Mapping
- Principles of LEAN Manufacturing

Linda J. Bovard, RAC
Linda J. Bovard is President of Bovard Consulting LLC. She provides regulatory consulting services to FDA-regulated companies, primarily in the medical device arena. Her services include strategic planning, pre-market submissions, labeling, training, and development, improvement, and auditing of Quality Systems. She has provided services to medical device companies for over 25 years, more than 15 years as a consultant. She has worked with entrepreneurs, virtual companies, start-ups, established small companies, and large conglomerates. Products range from sophisticated electronic devices with software to IVDs to personal use devices. Linda has a BA in Biology from Swarthmore College. She is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society and is a Certified Hazardous Materials Manager (CHMM) from the Institute of Hazardous Materials Management. She is committed to continuing education to keep up-to-date in this constantly changing field. She also passionately believes that understanding FDA is crucial for the success of regulated companies.

Classes taught:
- Preparing for Regulatory Inspections

 
Anja Bump
Anja Schnurer-Bump is the CEO and Founder of MONTGOMERY Strategic Consulting, LLC.  She has over 14 years of successful supplier management experience, including quality audits (she is a certified lead auditor), sales, marketing, and engineering. She has weathered the ups and downs of the semiconductor industry, as well as the tightly regulated medical industry. As a keen negotiator, quality remains number one in her mind.

Her corporate experience includes IBM, HP, Siltronic Ag (a German-owned wafer fab), Entegris, and Biotronik (medical supplier of implantable pacemakers and defibrillators). She has lived best practices for supply chain at large companies, and has implemented them at smaller ones. Best practices have made her life easier and she is currently working on spreading the joy to as many organizations as she can.

Anja holds a MS in Inorganic Chemistry from Portland State University and a Diploma in General Chemistry from Germany. German born, she is still fluent in German and English. She also manages to order a good dinner in French. She is a traveler, runner, and photographer.

Classes taught:
- Optimizing Your Supply Chain: Best Practices for Small to Medium Enterprises

 
Nick Campbell
Nick Campbell is the founder of Sunriver Risk Management, a consulting firm that specializes in compliance training for the bioscience industry. In 2008, he has delivered 20 training programs specifically for the Oregon Bioscience Association, covering regulatory issues in a variety of areas. He has spent his 21-year career working in operations for highly regulated industries, including the last 16 years in the pharmaceutical, medical device, and biotechnology sectors. His skills include a high level of proficiency in process engineering and facility operations. He has been instrumental in numerous regulatory audits including FDA, European Union, and Health Canada.

Classes taught:
- Managing an Effective Quality System
- Packaging and Labeling in an FDA Regulated Environment

Sara Dyson
Sara Dyson is the loss control manager for the Medmarc Insurance Group, which provides products liability insurance to the life sciences industry.  She develops products and services to assist companies control products liability risks, losses, and associated costs.  One of her primary responsibilities is to perform risk evaluations of life sciences companies and recommend tailored risk management solutions.  Sara is also responsible for developing educational resources that focus on products liability risk management and related specialty areas, such as FDA compliance and regulation, post-market surveillance, product safety, and recalls.  Sara regularly publishes articles on products liability risk management in industry magazines, such as Medical Device and Diagnostic Industry (MDDI) and Medtech Executive (MX) magazines.  Sara received her law degree from the University of Wisconsin Law School and is a member of the Wisconsin and Virginia Bar Associations.  She is also a graduate of the University of Michigan, where she received a BA degree.

Classes taught:
- Writing Defensively to Avoid Products Liability Litigation
- Developing Warnings & Instructions to Reduce Products Liability Risks and Communicate Effectively


Gary Hinkle
Gary C. Hinkle is President and Founder of Auxilium. His experience includes 20+ years in a broad variety of management and staff assignments with small, medium, and large companies involved in the development and manufacturing of high-tech products.  His mission is to help technical organizations achieve well-rounded, world-class excellence.  Auxilium's consultants and instructors have helped thousands of professionals and hundreds of businesses become more productive and collaborative.
 
Gary led several high-profile R&D projects including technical leadership of a $40 million program to improve U.S. Army vehicle maintenance worldwide (CTS-ICE program), and he directed the development of embedded systems used in the majority of Public Safety Answering Points for Enhanced 9-1-1 call processing.  He also led the hardware development for the world’s best selling oscilloscope product line at Tektronix. His design and management experience spans the electronics, mechanical and software engineering disciplines.  Since founding Auxilium, Gary has conducted workshops for hundreds of participants worldwide and provided management services for clients in various industries.
 
Currently, Gary serves as Industry Relations Chair and Immediate Past Chair for the IEEE Oregon Section, and he serves on the Program Management Forum board of directors.  He is a regular contributor of articles focused on R&D productivity and engineering leadership for IEEE-USA and the International Society for Optical Engineering (SPIE).

Classes taught:
- Engineers' Bootcamp

Don Lewis
Don Lewis is Principal, Lewis Consulting LLC, whose mission is to enable clients to improve their competitive performance through effective application of proven quantitative decision-making methodologies. Since establishing his consulting practice in 1986, Don has trained and mentored over five thousand technical professionals to apply quantitative methods, such as Statistical Process Control and Design of Experiments, in their project work. His consulting experience accrues from 50+ organizations across a diverse group of industries, including biosciences. Clients have achieved significant performance improvement, including proprietary breakthroughs, as a result of implementing his services.

Recently, as a Lead Instructor in Motorola University’s Digital Six Sigma Black Belt training program, Don has trained over two hundred and fifty Motorola Black Belts throughout the U.S., Europe, and Asia. Since 2003 his Northwest Lean Six Sigma clients have saved over $16 million in project work completed in conjunction with his training programs. He is an Adjunct Professor in both the Department of Management of Science & Technology at the OGI School of Science & Engineering in Portland, Oregon and the Atkinson Graduate School of Management at Willamette University. Don is also a chapter author of the recently published "Encyclopedia of Statistics in Quality and Reliability." He received his B.A. in mathematics from Claremont McKenna College and Ph.D. in biostatistics from the University of North Carolina at Chapel Hill. Don is an ASQ Certified Six Sigma Black Belt.

Classes taught:
- Analyzing Multi-factor Data
- Applying Statistical Process Control
- Design of Experiments
- Effective Problem Solving
- Measurement Systems Analysis
- Practical Data Analysis

 
Scott Lissit
Scott Lissit is an accomplished project manager, trainer, consultant and coach with more than 20 years experience working with customers in diverse industries such as aerospace, biotech, commercial electronics, government, R&D, and technology commercialization & development.  An excellent communicator, Scott is effective working at all levels in an organization from individual contributors to senior executives.

Scott brings a wealth of business and project experience to all of his assignments, enabling him to give multiple examples of practical applications relevant to each client’s unique situation.  Scott has trained thousands of people in project management, and has recorded numerous Podcasts for Cadence on current project topics.  Recently he worked with a major biotechnology company in California to develop a comprehensive risk management approach for all projects in their organization.  He also worked with senior NASA management after the Columbia accident to improve their risk analysis and safety-critical decision-making skills.  Scott has expertise in developing customized training curriculums, and has developed methods to measure their effectiveness and ROI.

Major career positions prior to Cadence include:  Senior Program Manager at the Center for Systems Management (2003 – 2007), Vice President and Senior Consultant at Lee Hecht Harrison (2000 – 2003), Project Manager at the National Technology Transfer Center (1997 – 1999), and Systems Engineer at TRW (now Northrop Grumman, 1988 – 1994).

Scott has a M.S. degree in Engineering from the University of Michigan, Ann Arbor, MI (Thermodynamics/fluids), and a B.S. degree in Mechanical Engineering, Magna Cum Laude from Bucknell University, Lewisburg, PA.  He is a certified Project Management Professional (PMP) from the Project Management Institute (PMI), and was certified by the International Coach Federation (ICF).

Classes taught:
- Project Risk Management

 
Scott Olsen
Scott Olsen founded The Olsen Group in 1999. Scott brings a combination of accomplishment and understanding of business matched with success in training individuals and groups.  After completing his undergraduate work in Economics at the University of Washington, Scott has developed innovative training methods throughout his career that produce dramatic increases in productivity and customer satisfaction.  With a combination of skills and knowledge, Scott successfully advances management, leadership, sales and interpersonal skills. He tailors each session to the particular needs of the group in which he is involved.

In addition to training, Scott provides personal career development for individuals and groups.

Classes taught:
- Customer Satisfaction Skills
- Effective Negotiation Skills
- Effective Presentation Skills

Jeff Oltmann
Jeff’s extensive experience includes running the Program Management Office (PMO) and a $60M project portfolio for IBM’s development facility in Oregon. He has managed new product development with program budget over $100M and worldwide cross-functional teams of over 100 members. His engineering teams have delivered many successful products to the marketplace, including multiple generations of mainframe-class computer systems.

Jeff’s background is a unique combination of engineering, program management, and executive staff, enabling him to move easily from the boardroom to the lab. Jeff’s “in the trenches” track record in product development ranges from start-ups to large corporations, including industry pioneers like Sequent, IBM, Prisma and Gould. Jeff is on the faculty of the Management of Science and Technology department at the Oregon Graduate Institute, where he teaches project management. He is a certified Project Management Professional® (PMP) and a member of the Institute of Management Consultants.

Classes taught:
- Project Management Foundations and Best Practices

Sheila Ramerman, RAC
Sheila Ramerman is the founder and Principal at SJR Associates, a medical device regulatory affairs, quality systems, and clinical affairs consulting practice located in Eugene, OR.  Her consulting practice puts particular emphasis on assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Her clients range from start-up companies who are developing home-testing and near-patient testing devices, to well-established, global medical device manufacturers.  Prior to founding SJR Associates, Sheila was responsible for regulatory affairs, quality systems, and/or clinical studies at small or start-up medical device companies in the San Francisco Bay Area, working with a variety of medical device technologies. Sheila has been a moderator and presenter for medical device seminars and webcasts for the Regulatory Affairs Professional Society, and has been a member of RAPS since 1995. She is a guest lecturer in the UC-Santa Cruz Regulatory Affairs Certificate Program, and has been affiliated with OBA’s BioPro WorkForce Training program since early 2007. Sheila began her career as a Medical Laboratory Technician and Clinical Laboratory Scientist in community hospital laboratories, and has worked in the medical device industry since 1989. Sheila holds an AA degree in Clinical Laboratory Technology from Shoreline Community College in Seattle, WA; a BA in Health Services Administration from Saint Mary’s College in Moraga, CA; and she has been Regulatory Affairs Certified since 1998.

Classes taught:
- Complaints, MDR & Adverse Reporting
- Corrective Action/Preventive Action (CAPA) for FDA Regulated Industries
- Creating and Maintaining Effective Documentation in the FDA Regulated Environment
- Design Controls for Medical Devices
- Labeling, Advertising & Promotion
- Technical Writing & Documentation within the FDA Regulated Environment

Iris Savich
Iris Savich, MA, is a national trainer and conference presenter with extensive experience in training and development. Her consulting firm, TAP Unlimited Corporation, specializes in management and supervisory courses, and personal growth seminars, such as cross-cultural communication, leadership, time management, and self-empowerment. She has designed and delivered successful leadership programs for entire organizations, including Portland Community College, Nike, American Express, PacifiCorp, and the City of Portland. Ms. Savich is an adjunct faculty member of Marylhurst University, Portland State University, and Portland Community College.

Classes taught:
- Frontline Management: Leveraging the Strengths of Your Style
- Planning and Time Management for Supervisors

 
Dorian Simpson, MBA
Dorian Simpson is the Managing Director of the Planning Innovations Group, a leading consultancy that helps companies develop market leading products and services through focused innovation planning and execution.  Since entering product development with IBM almost 20 years ago, Dorian has worked with leading innovators such as Motorola, AT&T, and Qwest, VTech, Rovi and many other startups and Fortune 500 companies to develop and execute new, high-potential opportunities.
 
Dorian has developed and delivers a range of highly acclaimed programs in product innovation leadership, financial skills, and planning strategies to share critical skills and methods. He leverages his practical experience with successful products as well as independent research and education to give leaders the tools to achieve maximum growth potential.

His workshop participants receive proven industry models, real world examples and case studies, along with interactive exercises to ensure participants can use their new skills in competitive markets to lead their companies. 
 
Dorian received a BSEE from Northwestern University and an MBA from the University of San Diego.

Classes taught:
- Financial Skills for Non-finance People