Expert Details
Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
ID: 723727
Virginia, USA
As a former FDA-trained auditor, the CIO of a medical device development company, an international author and now a consultant on this topic, Expert gets it - from the concerns of the shippping and receiving clerk to the worries of the CEO and his or her governance board. Expert publishes a monthly newsletter, SMARTERCOMPLIANCE, covering this topic, and has had his articles repeatedly syndicated around the globe. Caveat emptor: Expert provides practical, to the point advice.
Expert gets it - from the confusions of the IT help desk fellow to the worries of the CIO and CCO. Much of Expert's work in this area focuses on how companies can build validation into typical IT projects and processes to reduce costs without jeapardizing compliance. Expert provides practical, to the point advice with no bull. And, since he doesn't "sell" validation services, you don't need to worry about any hidden agendas.
His expertise on this is NOT as a lawyer; rather he focuses on how to secure your IP before it's stolen or your collaborator "borrows" a little too liberally. He's given speeches on how to do this for 3-man start-ups and large divisions, and recently wrote a significant article in the European Biopharmaceutical Review on how to protect your IP during drug and device development collaborations. Since the day Expert first started back in the IT industry, 15+ years ago, he's focused on securing information and intellectual property.
For the past 15+ years, Expert has been accountable for:
- identifying potential projects
- ensuring their alignment with business objectives
- prioritizing multiple projects
- obtaining funding and approvals for projects
- implementing projects
- overseeing project teams
- rescuing "failed" projects
- cleaning up / documenting projects
Expert's written several articles on this, all of which have been reprinted and syndicated around the world.
He helped a scientific product development & commercialization company shave 16 months off their development timeline by redesigning the roles of IT and marketing on their portfolio management board, implementing rapid-prototyping technology and then architecting an information management "book-shelving" strategy.He helped a medical device design organization reduce the time and the effort to validate its systems to FDA's 21 CFR Part 11 standards. For spreadsheets alone, the validation effort was reduced from 30 to 10 "man-days".For a Fortune 100 company, he was brought in to rescue a project running four months behind and $.5 million over budget by overseeing the three vendors and their project teams. Within 90 days, the project was 22 days ahead of schedule and under budget. The improved project customer satisfaction provided our client the opportunity to ask us to implement additional "nice-to-have" project components during the "recovered" days.Bringing together line-of-business and IT executives, he facilitated creation of a continuous improvement framework for IT that saw business satisfaction rise from 6.1 to 9.7 (out of 10) within twelve months. The business received better service and IT received more funding and freedom.For an engineering group, he designed a proactive system maintenance plan and a "compliance health check" program, that increased the usability of high-end graphical modeling systems from four to six years, allowing two years of funding (that would have been spent on new computers) to shift to other company projects.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1995 | Degree: MS | Subject: Cultural Geography | Institution: University of Kansas |
| Year: 1990 | Degree: BA | Subject: Government & East Asian Studies | Institution: College of William & Mary |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2006 to Present | Employer: Undisclosed | Title: Managing Director, Co-Founder | Department: Undisclosed |
Responsibilities:Managing director, principal consultant and co-owner of firm |
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| Years | Employer | Title | Department |
| Years: 2005 to 2006 | Employer: Philip Morris USA | Title: Undisclosed | Department: Information Services / R&D and Product Development |
Responsibilities:Divisional CIO/CTO for the product development and commercialization division of Philip Morris USA, Inc. Business consultant to Enterprise IS organization for the new research & development metropolitan campus. Oversaw merger and acquisition of Chrysalis Technologies. |
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| Years | Employer | Title | Department |
| Years: 2000 to 2005 | Employer: Undisclosed | Title: CIO | Department: Undisclosed |
Responsibilities:Reported to the CFO for a product development and commercialization subsidiary of the Altria Group, Inc.. Strategic projects included ISO 17799 compliance, portfolio management, and FDA 21 CFR Part 11 compliance. Yearly budget averaged 8% of total organizational budget. |
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| Years | Employer | Title | Department |
| Years: 1998 to 2000 | Employer: Philip Morris USA | Title: Undisclosed | Department: R&D |
Responsibilities:Managed the IS department of 2 trade-secret, research & development facilities. Built successful cross-functional project teams while maintaining client confidentiality. Managed budgets of mixed IS and business assets and projects; provided oversight for all IS purchases and budgets for Philip Morris’s $2B R&D Division. Later led a cross-company (Altria, Philip Morris, Kraft), $3.5M project to conceptualize, design and build an IT infrastructure specialized in engineering and scientific environments for new operating company, Chrysalis Technologies. Invited to join Chrysalis as CIO. |
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| Years | Employer | Title | Department |
| Years: 1997 to 1998 | Employer: IPC Technologies | Title: Undisclosed | Department: Project Management |
Responsibilities:Team leader of a five person team in a time-sensitive project at two Philip Morris USA manufacturing facilities - rescued project to be 1 month ahead of schedule and $100K under budget. Retained as internal technology consultant to business client factory management. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1997 | Employer: PSI | Title: Undisclosed | Department: Information Services |
Responsibilities:National environmental engineering firm in which position reported directly to the CIO and handled budgeting, procurement, project management and security – both physical and electronic. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1996 | Employer: Undisclosed | Title: Systems Support Analyst & Trainer | Department: Undisclosed |
Responsibilities:For this small, now defunct, consultancy, migrated 600+ users from mainframe to PC environment. Later sub-contracted to design and build the project office computing environment for a world-wide SAP R/3 conversion. |
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| Years | Employer | Title | Department |
| Years: 1994 to 1995 | Employer: Allen Marketing & Management | Title: Undisclosed | Department: Undisclosed |
Responsibilities:Responsible for advertising, marketing and contract negotiations for 10 scientific journals and organizations at Allen Press, a $25M company. Increased advertising revenue of clients’ by an average of 23% over 1 year. Authored internal whitepaper on Internet revenue opportunities for Allen Press. Developed new contract terms for clients (saved $8,000 a year per client).Beta-tester for Microsoft for Windows 95. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 1988 to 1999 | Agency: Department of Defense - Defense Logistics Agency | Role: Internship | Description: He spent two summers interning in the Defense Command Support Office, researching new weaponry, logistical capabilities and preparing presentations for senior generals, top diplomats, and senators and cabinet members. |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2005 to 2005 | Country / Region: Ireland | Summary: During an IVT conference, he was invited to coach and provide in-depth advice to numerous executives just starting compliance programs (or shifting their compliance programs from an EU-focus to a broader EU, ISO and FDA focus). |
Career Accomplishments
| Associations / Societies |
|---|
| American Management Association (AMA); Regulatory Affairs Professional Society (RAPS); Management Roundtable / FastTrack; Institute of Management Consultants (IMC USA); Society of Professional Consultants (SPC); Instititue of Validation Technology (IVT); American Society for Quality (ASQ); Independent Computer Consultants Association (ICCA); Product Development & Management Association (PDMA); Food & Drug Law Institute (FDLI); Information Systems & Controls Association (ISACA); Virginia Biotechnology Association (VaBIO); IT Compliance Institute (ITCI); N-TEN (nonprofit technology development association); Hampton Roads Technology Council; Society for Information Management (SIM); World Future Society (WFS) |
| Licenses / Certifications |
|---|
| MCP |
| Professional Appointments |
|---|
| PC Magazine Advisory Board; INC Magazine Inner Circle; Microsoft Internet Research Panel |
| Publications and Patents Summary |
|---|
| He has 8 internationally syndicated articles and one recent booklet on controlling compliance costs. |
Additional Experience
| Training / Seminars |
|---|
| "Dealing Successfully with Your IT Department for Non-IT Executives"; "Cost-Effective IT Strategies for Nonprofits"; "ISO Records Compliance Overview" |
| Vendor Selection |
|---|
| Laboratory equipment vendors, facility equipment vendors, computer hardware and software vendors, IT outsource vendors, contract research and contract laboratory organization vendors, contract manufacturers, print shops, marketing outsource providers |
| Marketing Experience |
|---|
| When advertising manager, increased revenue of clients an average 23%. Founded own consulting company. |
Language Skills
| Language | Proficiency |
|---|---|
| Note that co-founder and partner in firm is completely fluent in Spanish (particularly centro-American Spanish) |
Fields of Expertise
electronic system program management, Food and Drug Administration compliance, Food and Drug Administration validation, intellectual property, project assessment, project execution planning, project management, project planning, project review, project scheduling, software project management, software intellectual property, intellectual property security, project appraisal, commercialization, mentoring, stage gate process, post project appraisal, self-directed work team, business management, ideation, Current Good Manufacturing Practice, proposal writing, joint venture, pharmaceutical product development, rapid product development, corporate strategic planning, biomedical product development, productivity improvement, integrated product development, specification documentation process, electrical product development, device product development, new product development, research and development, research and development management, project management software selection, electronic product development, new product development management, innovation, Food and Drug Administration regulation, drug regulation, risk management, research and development productivity, planning, FDA medical device regulation, Good Manufacturing Practice, Good Laboratory Practice