GCPLEARNING - Key Persons

Job Titles:

• President and Director of SOX for Lord & Benoit
• President, Lord & Benoit, LLC

Bob Benoit is President and Director of SOX for Lord & Benoit. Served on the most recent COSO Monitoring Project Task Force. Served on AICPA Peer Review Acceptance Board for ten years. Author of most the Lord & Benoit Reports, which have been referenced by the SEC, PCAOB, Wall Street Journal, all Big 4 firms and over 150 trade journals worldwide. First evaluator to use the 2006 COSO Guidance for Smaller Public Companies. Invented Virtual SOX. Significant contributor to SEC Interpretive Guidance, SEC/PCAOB Roundtables and SEC Subcommittee on Internal Controls.

Job Titles:

• President of C. H. Paul Consulting, Inc
• President, C. H. Paul Consulting, Inc.

Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues. He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. He has dedicated his entire professional career explaining the benefits of performance-based training

Job Titles:

• Founder and President of Pinnacle Performance Improvement Worldwide

Chris DeVany is the founder and president of Pinnacle Performance Improvement Worldwide, a firm which focuses on management and organization development. Pinnacle's clients include global organizations such as Visa International, Cadence Design Systems, Coca Cola, Sprint, Microsoft, Aviva Insurance, Schlumberger and over 500 other organizations in 22 countries. He also has consulted to government agencies from the United States, the Royal Government of Saudi Arabia, Canada, Cayman Islands and the United Kingdom. He has published numerous articles in the fields of surviving mergers and acquisitions, surviving change, project management, management, sales, team-building, leadership, ethics, customer service, diversity and work-life balance, in publications ranging from ASTD/Performance In Practice to Customer Service Management. His book, "90 Days to a High-Performance Team", published by McGraw Hill and often accompanied by in-person, facilitated instruction, has helped and continues to help thousands of executives, managers and team leaders improve performance. He has appeared hundreds of times on radio and television interview programs to discuss mergers and acquisitions (how to manage and survive them), project management, sales, customer service, effective workplace communication, management, handling rapid personal and organizational change and other topical business issues. He has served or is currently serving as a board member of the International Association of Facilitators, Sales and Marketing Executives International, American Management Association, American Society of Training and Development, Institute of Management Consultants, American Society of Association Executives, Meeting Professionals International and National Speakers Association. Chris is an award-winning Toastmaster's International Competition speaker. He recently participated in the Fortune 500 Annual Management Forum as a speaker, panelist and seminar leader. Chris has distinguished himself professionally by serving multiple corporations as manager and trainer of sales, operations, project management, IT, customer service and marketing professionals. Included among those business leaders are Prudential Insurance, Sprint, BayBank (now part of Bank of America), US Health Care and Marriott Corporation. He has assisted these organizations in mergers and acquisitions, facilitating post-merger and acquisition integration, developing project management, sales, customer service and marketing strategies, organizing inbound and outbound call center programs, training and development of management and new hires, and fostering corporate growth through creative change and innovation initiatives. Chris holds degrees in management studies and organizational behavior from Boston University. He has traveled to 22 countries and 47 states in the course of his career.

Job Titles:

• Author - Safer Hospital Care ( Taylor & Francis ), Patient System Safety

Dev Raheja MS,CSP, author of Safer Hospital Care: Strategies for Continuous Innovation, is an international risk management, patient safety and quality assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. Currently he is an Adjunct Professor at the Florida Tech University for its Business Administration degree in Healthcare Management. He is a Certified Safety Professional through the Board of Certified Safety Professionals, took training in "Perfecting Patient Care" through the Pittsburgh Regional Health Initiative, an organization supported by 40 hospitals, and is a member of the American College of Healthcare Executives. He is a former National Baldrige Award examiner among the first batch of examiners. He is the author of the forthcoming book "Preventing Medical Device Recalls (Taylor & Francis)

Job Titles:

• Principal Consultant, Bilanx Consulting LLC

During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.

Job Titles:

• Managing Director, PrimeGenesis

George Bradt has a unique perspective on transformational leadership based on his combined senior line management, consulting, and journalistic experience. He progressed through sales, marketing and general management roles around the world at companies including Unilever, Procter & Gamble, Coca-Cola, and J.D. Power's Power Information Network spin off as chief executive. Now he is a Principal of CEO Connection and Managing Director of the executive onboarding group PrimeGenesis. George is a graduate of Harvard and Wharton (MBA), author of five books on onboarding including The New Leader's 100-Day Action Plan, the New Leader Smart Tools iPad app, and The New Leader's Playbook weekly column on Forbes.com

Jennifer Slay has spent the last 20 years as a registered social worker working with various populations. She is also a certified life coach, motivational speaker, trainer and author. Jennifer has earned two honors bachelor's degrees, a master's in social work and is a certified Extended DiSC trainer. She has also been trained in EMDR therapy. Jennifer was chosen as one of the recipients of the Queen Elizabeth the II Diamond Jubilee medal in 2013 for her community work and as one of Canada's women of confidence in the national publication, Chatelaine magazine. For the last five years, Jennifer has opened a private practice in coaching and counselling, has taught online courses, has been invited to speak in various settings from service clubs to major corporations and has been travelling with her children to various parts of the world. She is living what she preaches and is excited to partner with TrainHR to provide content to support your growth. Testimonials: If you are ready to do the work to see where that inner critic started and how to manage those negative thoughts, I recommend you work with Jen. Jen Slay is highly skilled at supporting you to gain clarity and take positive action. If you are looking to learn skills, tools, and techniques to increase and enhance mood, manage life situations in a positive manner, and take better care of yourself, call on Jen. - Jennifer Jimbere, Business strategist Jennifer can raise energy and build confidence with her topics of motivation and inspiration. Don't miss an opportunity to book the speaker that will leave your audience wanting to be more and do more in their lives - Sarah Hilton; Certified World Class Speaking Coach

Job Titles:

• Attorney
• Health Care Attorney

Joseph Wolfe is an attorney with Hall Render, the largest healthcare-focused law firm in the country. Mr. Wolfe supports high-performing hospitals, health systems, medical groups, and other healthcare organizations nationwide on complex financial, legal, regulatory, and strategic issues both as a consultant and attorney, depending on the scope of support, client preference, and need. He is a frequent speaker for most of the national healthcare trade associations and has given over 200 in-person, web-based, and podcast presentations in recent years. He is the leader of Hall Render's healthcare regulatory practice group and currently serves as the vice chair of educational programming for the American Health Law Association's Fraud & Abuse Practice Group. He is licensed as an attorney in both Florida and Wisconsin.

Job Titles:

• Owner, McElroy Training and Consultancy, LLC

Joy McElroy Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence. Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance. In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off - site training to pharmaceutical and biotech companies throughout the United States. Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.

Job Titles:

• President of Perform to Potential
• President, Perform to Potential, Inc.

Pauline Khem is president of Perform to Potential, a coaching and training company that helps professionals create careers they find both rewarding and meaningful. She helps her clients reconnect with their personal purpose and power and integrate it daily in their professional lives. Pauline believes that the workplace is the ideal environment to develop the self-awareness and skills that will unlock our latent potential and uplift every aspect of our lives - and the lives of others. Pauline's corporate experience includes 25 years in the financial services industry, helping senior executives throughout the U.S., Europe and Asia develop strategies to attract and retain clients. She has also owned her own travel business and served as a national training director in the cosmetics industry. Throughout her career she's trained groups and individual clients around the world in sales, productivity, leadership and personal development. She is immediate past president of the American Business Women's Association NYC chapter and the current secretary of the National Speakers Association NYC chapter.

Job Titles:

• President & CEO, RJR Consulting, Inc.
• Regulatory and CMC Expert

Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices. His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products. For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries. He holds a BS / MS in Chemistry."

Sonia Friedrich has an extensive corporate career spaning more than 25 years working in executive roles in advertising and marketing. She has worked for Fortune 500 companies, not-for-profits and small business. She was the General Manager for the Sydney arm of a global advertising agency. Sonia established her own strategic consultancy 11 years ago and moved to the idyllic coastal town of Byron Bay in Australia. She now works as a Mentor to Multi-millionaires, Senior Executives, Business owners and Individuals to help empower them to live all of who they are.

Job Titles:

• Consultant & Programmer, Pc Guy Consulting INC

Tom Fragale is a computer professional with over 30 years of professional experience. He is a Microsoft Certified Trainer, and a Microsoft Certified Expert in Excel. He has trained over 30,000 business people in on-line webinars, public seminars, and on-site training. His clients include many Fortune 500 companies, government agencies, military bases, and companies large and small across many industries, including manufacturing, banking, pharmaceutical, education, retail, etc. He started his career as a database application programmer and has served as a consultant and project manager on many successful projects. His topics of expertise include: Access, Excel, Word, PowerPoint, Outlook, Crystal Reports, SQL Server, Visio, QuickBooks, and SharePoint, among others. His passion is training people and helping people get the most out of their computers, and he is a published author having written a book on Microsoft Access. He graduated in 1988 from LaSalle University in Philadelphia, PA with a BA in Computer Science.