Panelists

James Russell

James Russell
Director, Regulatory Affairs for RJR Consulting, Inc.

Mr. Russell is the Director of Business Development and Regulatory Affairs for RJR Consulting Inc, a leading global regulatory consulting firm servicing the Life Science and Consumer Products industries…more

Steven Walfish

Steven Walfish
President of Statistical Outsourcing Services

Steven Walfish , is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries…more

Robert J Russell

Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry…more

Bill Schwemer

Bill Schwemer
Principal, Schwemer Consulting and former Senior FDA & Industry Official

Bill Schwemer is an ex-FDA official having more than 50 years’ experience with FDA compliance matters. He has worked as an FDA field Investigator and Compliance Officer, been a senior official with FDA’s Office of the Commissioner…more

David Nettleton

David Nettleton
FDA Compliance Specialist, Computer System Validation

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of …more

Mukesh Kumar

Mukesh Kumar
PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research

Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown…more

Kim Huynh Ba

Kim Huynh-Ba
Executive Director of Pharmalytik

Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Ms. Huynh-Ba currently is the Executive Director of Pharmalytik…more

Richard Barr

Richard Barr
Operational Risk & Back Office Specialist

Richard Barr , holds a B.S. in International Business Administration from San Jose State University in California. His professional experience spans over 23 years, 5 of which were spent with Wells Fargo Bank. Another 5 were spent honing his global banking skills, when Richard was intimately …more

Rita Hoffman

Rita Hoffman
RAC, Managing Partner Regs & Recall Strategies, LLC

Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides …more

Karl Nobert

Karl M. Nobert
Food and Drug Regulatory Attorney, Squire Sanders (US) LLP, Washington, DC

Karl M. Nobert is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval …more

Fubin Wu

Fubin Wu
Co-founder of GessNet, Solutions for Medical Device Safety, Cybersecurity and Regulatory Compliance

Fubin Wu is the Co-Founder of GessNet (http://www.gessnet.com). He architected and led the development of TurboAC™ risk management & assurance case software, in close communications with FDA – Office of Science & Engineering …more

Jim Sheldon Dean

Jim Sheldon-Dean
Principal and Director of Compliance Services, Lewis Creek Systems, LLC

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of health …more

Subhash Patel

Subhash R Patel
Regulatory Affairs & Quality Compliance Consultant at MD Reg Consulting, LLC

Subhash Patel is a seasoned and well-accomplished Regulatory Affairs and Quality professional with over 27 years of Global Regulatory Affairs experience in highly regulated medical device industry. Mr. Patel is a founder and owner of MD …more

Ronald Carlson

Ronald H. Carlson
Regulatory Affairs and Quality Consultant, Carlson Consulting

Ronald H. Carlson Ph.D. has more than 25 years of pharmaceutical industry experience in Regulatory Affairs and Quality. His experience is in the areas of both drugs and biologics in both small and large companies …more

Beth Brascugli De Lima

Beth Brascugli De Lima
CEO, Principal Consultant at HRM Consulting, Inc.

Beth Brascugli De Lima, M.B.A., SPHR-CA, is founder, president, and principal of HRM Consulting, Inc., a California-based human resource consulting firm. Ms. De Lima provides corporate consulting on a national basis regarding employment regulation, compliance and vocational rehabilitation. Her organization has assisted …more

Laura Goldzung

Laura H. Goldzung
President and Founder of AML Audit Services, LLC

Laura H. Goldzung is President and Founder of AML Audit Services, LLC, an anti-money laundering and fraud consultancy specializing in independent testing and compliance consulting services to financial and nonbank financial institutions. Mrs. Goldzung’s expertise include domestic and international training, design and …more

Michael Swit

Michael A Swit
Esq, FDA Lawyer

Michael A. Swit focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the …more

Brent Meyers

Brent Meyers
Vice President – Commerce Bank

Brent Meyers has worked for Commerce Bank since May 2008 and is responsible for business development and commercial card services within the Midwest Territory. Mr. Meyers specializes in Automated Accounts Payable and Electronic Invoice Presentment and Payment (EIPP) solutions. Prior to joining Commerce Bank, he spent …more

Karl Hemmerich

Karl J. Hemmerich
President- Ageless Processing Technologies

Mr. Karl J. Hemmerich, President of Ageless Processing Technologies, has over 35 years of experience in medical device product design, development, manufacturing, and sterilization. He specializes in sterilization method selection and program development with emphasis on component material selection, process development and …more

Harvey Rudolph

Dr. Harvey Rudolph
HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)

Dr. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management. He has been a member of the Joint Working Group on Risk Management since it began in 1995 and is a primary author of ISO 14971. Currently he co-chairs the US Technical Advisory Group for that …more

Casper Uldriks_90x112

Casper E. Uldriks
Former Associate Center Director of FDA’s CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for. …more

Jonathan Lewis

Jonathan M. Lewis
Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC

Jonathan M. Lewis, founding partner, Reliant FDA Experts™ – a division of Advanced Biomedical Consulting, LLC, has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both the industry and in consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries….more

Koshy George

Koshy George
President- Koshy & Associates Consulting, Inc

Koshy George has more than twenty years of experience in validation within the pharmaceutical and biopharmaceutical industries. Mr. George is currently President of Koshy and Associates Consulting Services Inc. He is working as a Quality Assurance Consultant for Cleaning Validation at Genzyme in Boston. Prior to this he was …more

Marian Boardley

Marian Boardley
Consultant, Marian Boardley Consulting LLC

Marian Boardley is an independent consultant who manages projects for dietary supplement manufacturers and distributors. She helps clients in the food, drug, and dietary supplement industries to implement compliance with dietary supplement, food, and other cGMP’s. She regularly trains staff to be ready for FDA inspections and …more

Jan Seal

Jan Seal
International Trade Consultant

Jan Seal is a Management Consultant on International Trade and a Licensed Customhouse Broker with over 35 years of experience in imports and exports. Ms. Seal is a frequent speaker/instructor at nation-wide seminars and webinars for international companies located around the world and international trade organizations. She is …more

Martina LaGrange

Martina LaGrange
Principal, FDA Compliance Group LLC

Ms. Martina LaGrange began her career in Seattle, WA as an FDA Field Investigator. She moved back home to Denver, CO in 1996 where she completed her 14 year career with the FDA as a Medical Device Specialist….more

Shelly Maifarth

Shelly Maifarth
Principal, FDA Compliance Group LLC

Ms. Maifarth began her career with FDA as an investigator and microbiologist in Dallas and Denver Districts from 1972 to 1984, then served as an FDA Compliance Officer in Denver’s District Office for more than 22 years. As a compliance officer, she has significant experience in the medical device, ….more

Dan O Leary

Dan O’Leary
President at Ombu Enterprises, LLC

Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Mr. O’Leary has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, ….more

Joan Pastor

Joan Pastor
Ph.D., President, JPA International, Inc.

Joan Pastor, Ph.D., president of JPA International, Inc. is a licensed organizational and clinical psychologist who provides keynote, training and consultation services to numerous national and international organizations and associations. Ms. Pastor is a certified speaking professional (CSP), a certified mediator, and has an extensive ….more

Ludwig Huber

Dr. Ludwig Huber
Director and Chief Editor, LabCompliance.

Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion….more

Peter Goldmann

Peter Goldmann
MSc, CFE, Owner, White-Collar Crime 101 LLC

Peter Goldman has 25 years of experience as a business journalist and trainer, having launched, edited and published numerous business trade periodicals covering small business, international trade, management strategy, banking and personal finance. Mr. Goldman is a Certified Fraud Examiner (CFE) and a member of the ….more

David Haggard

David Haggard
GMP Regulatory Consultant, David Haggard Associates LLC

David Haggard: Currently leads a consulting practice offering auditing, training and advising to small, medium and large pharmaceutical firms as a follow-up to a 30+ years’ experience with the U.S. FDA and 10+ years with Merck & Co., Inc. His experience with the FDA started as an investigator and advanced to supervisory ….more

Sheila Gladstone

Sheila B. Gladstone
Principal, Attorneys and Counselors, Lloyd Gosselink Rochelle & Townsend, P.C

Sheila Gladstone heads up Lloyd Gosselink’s Employment Law Practice Group and has over 25 years’ experience assisting employers with all aspects of employment law. Ms. Gladstone is a frequent and entertaining speaker and a published author on a variety of employment-related issues. She uses a direct approach and gives….more

Michael Hamrell

Michael Hamrell
President, MORIAH Consultants

Dr. Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. Dr. Hamrell has worked in drug development, clinical research and regulatory affairs for over 30 years. He has worked in pharmaceuticals, contract….more

Vicki Lambert

Vicki M. Lambert
President and Academic Director – The Payroll Advisor™

Vicki M. Lambert, CPP is President and Academic Director of The Payroll Advisor™ a firm specializing in the training of payroll professionals. With over three decades of hands-on experience in all facets of payroll functions as well as over 20 years as a trainer and author, Ms. Lambert is a sought-….more

Marna Hayden

Marna Hayden
Founder and President, Hayden Resources Inc.

Marna Hayden is founder and president of Hayden Resources Inc. She has 30+ years in the field of human resource management and is certified as a senior professional in human resources (SPHR). Hayden Resources Inc. provides management and human resources consulting and outsourcing….more

Nadine M Ritter

Nadine M. Ritter
Senior CMC Consultant at Biologics Consulting Group, Inc.

Nadine M. Ritter, Ph.D., senior consultant for Biologics Consulting Group, Inc., is a protein chemist with expertise in the chemistry, manufacturing and control (CMC) of biotechnology products. She is past Director of Analytical Services Division at major contract testing organization performing R&D, GLP and GMP analytics studies….more

T.C. Soli

T.C. Soli
President of Soli Pharma Solutions, Inc

T.C. Soli, Ph.D., is President of Soli Pharma Solutions, Inc, with training, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 34 years of combined pharmaceutical experience as a consultant and with operating companies…more

Sean_Develin_90_112

Sean Develin
Director, DevRose Systems Ltd.

Sean Develin is the co-founder of DevRose Systems, a UK-based consultancy delivering IT governance and infrastructure and regulatory compliance solutions to companies worldwide. Between 2009 and 2010, he helped launch the MUSA Validated Cloud, one of the first GxP compliant…more

Dannie Rowland

Dannie Rowland
Former FDA Senior Compliance Officer& Acting Director of Compliance for LA District

As an ex-FDA investigator for over 30 years, Dannie Rowland performed numerous FDA inspections, issued numerous 483s and warning letters for manufacturers of medical devices, pharmaceuticals, drugs…more

Gina Lowdermilk_90x112

Gina J. Lowdermilk
BSA/Compliance Auditor and Consultant

Dr Gina J. Lowdermilk, PhD (ABD), CAMS, CRMS is a highly experienced and educated BSA/AML and Financial Regulatory Compliance professional with extensive policy and procedure development and implementation, training, internal audit, monitoring, risk management, and reporting experience. Her emphasis …more

Leo Lagrotte-90X112

Leo J. Lagrotte
Sr. Regulatory Consultant, Quality Solutions and Support, LLC and Former FDA Consumer Safety Officer

Leo J. Lagrotte is a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers as a follow-up to 20 plus …more

Stephen_Inglese_90_112

Stephen Inglese
Founder and CEO, Quality Solutions and Support, LLC

Stephen Inglese is a Founder and CEO of Quality Solutions and Support, LLC. Mr. Inglese began his Quality Systems career with Florida Power and Light (FPL) Company in South Florida. During his career with FPL, he…more

David_Casavant_90_112

David A. Casavant
Executive Director, The Sustainable Workplace Alliance

David Casavant, CFM, LEED AP is the Executive Director of the Sustainable Workplace Alliance, a 501(c)(3) not-for-profit organization dedicated to Health & Safety in the workplace. He is known for his common sense solutions for complex compliance…more

Martell Winters

Martell Winters
Senior Scientist – Nelson Laboratories

Martell Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. Mr. Winters has been at Nelson Laboratories for 20 years and spent most of that time working in the Radiation Sterilization group…more

Steven_Lehat_90_112

Steven Lehat
Founder and President of Law Business World

Steven Lehat is an attorney with over thirty years of experience. He has worked with many multinational corporations including Hyundai, Pier 1 Imports and Bacardi, managing accounts worth hundreds…more

Norman_Marks_90_112

Norman Marks
Evangelist for Better Run Business and Mentor in Internal Auditing, Risk Management and Corporate Governance.

Norman Marks CPA, CRMA has been Chief Audit Executive of major global corporations for over 20 years, and is one of the most highly regarded thought leaders in the global…more

Barry_A_Friedman_90_112

Barry A. Friedman
Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include…more

Steve_Yeger_90_112

Steve Yeger
President- Technical Consultant, Steven C. Yeger Consulting Inc.

Steve Yeger is owner and President of Steven Yeger Consulting, a consulting firm based in the United States that has serviced pharmaceutical clients worldwide. Prior to starting his Consulting career, Steve worked for Wallace Laboratories…more

john_lincoln_large

John E Lincoln
Principal, J. E. Lincoln and Associates LLC.

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant…more

Glenn-Neuman-90X112

Glenn Neuman
Director of Scientific Affairs at New World Regulatory Solutions, Inc.

Glenn Neuman is a seasoned Regulatory Affairs professional with an R&D background. Mr. Neuman has over 20 years’ experience with CLIA Waivers, and presented at CLIAC meetings and at FDA’s watershed CLIA Waiver public workshop…more

Phyllis_Patrick_90_112

Phyllis Patrick
Information Security, Privacy & Compliance Professional, Founder and President at Phyllis A. Patrick & Associates LLC.

Phyllis Patrick is Founder and President of Phyllis A. Patrick & Associates LLC, a consulting group specializing in providing strategic planning, security, and privacy services to the health care industry. The company’s practical approach to security…more

Robert_Minniti_90_112

Robert K Minniti
President and Owner of Minniti CPA, LLC

Robert K Minniti (Bob) is the President and Owner of Minniti CPA, LLC. Bob is a Certified Public Accountant, Certified Forensic Accountant, Certified Fraud Examiner, Certified Valuation Analyst, Certified in Financial Forensics…more

Stanley-Epstei-90x112n

Stanley Epstein
Banking, Payments, Operational Risk & Back Office Specialist and Bank Trainer

Stanley Epstein has had extensive experience in banking and IT specifically the operations, payments, RTGS and the operational risk aspects of banking in the UK, Europe, the USA, Australia and Southern Africa. His bank-operations…more

Cherie_Hennig_90_112

Cherie J. Hennig
Ph.D, CPA

Cherie Hennig, Ph.D., is the co-author of the treatise, Practical Guide to Schedule M-3 Compliance, 2nd edition, published by CCH. She has published numerous articles on Schedule M-3 and Schedule UTP compliance which have appeared in The Tax Advisor…more

Robert_Brewer_90_112

Robert Brewer
Internal Audit and Compliance Consultant

Robert Brewer served as Senior Vice President and Chief Compliance Officer for Office Depot since 2005. In this role, Bob had overall responsibility for compliance activities on a global basis for a retailer who provided supplies and services to its customers through 2,200 worldwide retail stores,…more

James_Barley_90_112

James Barley
Regulatory Affairs and Quality Assurance Consultant

Sean Develin is the co-founder of DevRose Systems, a UK-based consultancy delivering IT governance and infrastructure and regulatory compliance solutions to companies worldwide. Between 2009 and 2010, he helped launch the MUSA Validated Cloud, one of the first GxP compliant…more

Markus_Weber_90_112

Markus Weber
Principal Consultant, System Safety, Inc.

Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. Mr. Weber graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering…more

Edward_Goldberg_90_112

Edward Goldberg
Adjunct Professor International Trade, Baruch College of the City University of New York/ NYU’S Center for Global Affairs

Edward Goldberg has over 35 years experience in international business, global markets and academia. He is an Adjunct Professor at Zicklin Graduate School of Business, Baruch College, City University of New York…more

Nanda-Subarao_90x112

Dr. Nanda Subbarao
Senior Consultant, Biologics Consulting Group

Dr. Nanda Subbarao is currently a senior consultant with the Biologics Consulting Group specializing in analytical, stability, CMC and GLP/GMP quality systems. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs….more

Stephen_J_Cipolla_90_112

Stephen J. Cipolla
Founder of Stephen Cipolla Legal Strategies

Stephen J. Cipolla is the founder of Stephen Cipolla Legal Strategies; a Philadelphia area law firm dedicated to providing cost-effective, practical legal guidance to entrepreneurs, start-ups, and established businesses of all sizes. He counsels clients on all aspects of business law, including contracts….more

Jeff_Morgan_90_112

Jeff Morgan
Principal Consultant, JWM Associates, LLC

Jeff Morgan has over 30 years of combined experience in medical device consulting, development of medical devices and clinical laboratory management. His expertise includes quality systems (FDA QSR, ISO 9001 and ISO 13485) consulting and auditing….more

Lawrence_Heim_90_112

Lawrence Heim
Director – EHS/Environmental Risk, Conflict Minerals and Sustainability

Lawrence Heim is a Director in the Atlanta office of Elm Sustainability Partners, a wholly-owned subsidiary of The Elm Consulting Group International LLC, an independent environmental, health, safety and sustainability (EHSS) consulting practice….more

Mark-Gardner_large

Mark Gardner
M.B.A., J.D.,Attorney and Adjunct Professor at DuVal & Associates

Mark Gardner, M.B.A., J.D., is an attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, dietary supplement, drug, biotech, and food industries…..more

Betty Lane

Betty Lane
Founder and President of Be Quality Associates, LLC

Betty Lane has over 30 years’ experience in medical device quality assurance and regulatory affairs. She is the founder and president of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems……more

Andrew_Campbell_90_112

Andrew Campbell
Pharmaceutical Consultant – Quality & Compliance

Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation – CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management…….more

Jason-Mefford_90x112

Jason Mefford
President, Mefford Associates

Jason Mefford is an internationally acclaimed trainer and business coach. He specializes on ethics, corporate governance, risk management, compliance, GRC and internal audit topics. He is currently the president of Mefford Associates, a professional training, coaching and boutique advisory firm……..more

Jonnie Keith-90X112

Jonnie T. Keith
CIA, CFE, CGAP, CICA

Jonnie Keith has been in auditing over 40 years. He retired in 2012 as the Assistant General Manager (AGM) of Internal Audit with the Metropolitan Atlanta Rapid Transit Authority (MARTA) in Atlanta, Ga. He served in that capacity for over 10 years and was responsible for administering the overall audit activities including: Providing the Board of Directors, the General Manager/CEO (GM/CEO),……..more

Lester Rosen-90X112

Lester S. Rosen
CEO of Employment Screening Resources

Lester Rosen is an attorney at law and CEO of Employment Screening Resources (ESR), a national background screening company accredited by the National Association of Professional Background Screeners (NAPBS). He is a consultant, writer, and frequent presenter nationwide on pre-employment screening and safe hiring issues. He has qualified as an expert witness on issues surrounding safe hiring and due diligence. He has been a speaker for numerous national and statewide conferences………more

Cathleen-M-Hampton_90x112

Cathleen M. Hampton
Human Resource Compliance & Risk Management Consultant

Cathleen Hampton has more than 25 years of experience as a human resources professional providing subject matter expertise in areas such as human capital and work force planning. She serves as full service HR Leader responsible for the alignment of personnel with strategic mission and service level requirements. She is noted for her ability to understand the nuances of her client environments and designing solutions that optimize human capital that best meet the needs of the organization……….more

Angela Bazigos_90x112

Angela Bazigos
CEO, Touchstone Technologies Silicon Valley Inc.

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance………..more

Miles Hutchinson

Miles Hutchinson
CGMA, CPA and President of Sales Tax Advisors, Inc.

Miles Hutchinson is a CGMA, and experienced businessman. He has been an auditor with PriceWaterhouseCoopers and the Chief Financial Officer of a $1 billion real estate development company. Miles is a professional speaker and consultant who has presented over 2,000 seminars and training sessions on a myriad of business and financial topics…………more

Brian Hendrickson-90X112

Brian Hendrickson
Director, BPHendrickson Consulting LLC; Retired FDA National Food Expert

Brian Hendrickson is a retired FDA National Food Expert with more than 35 years’ experience with the agency. As a national expert, he helped develop FDA regulatory policy for high-risk foods and trained FDA and state food inspectors nationwide in food technologies and related hazards, FDA regulations and inspection techniques. He has conducted FDA inspections of food manufactures internationally. Since his retirement in 2011…………more

Daniel Clark-90X112

Daniel Clark
CRCMP, CISRCP, SVP General Auditor at Washington Trust Bank

Daniel Clark has over 25 years of experience in risk management and auditing having served in many senior auditing/risk roles culminating as chief auditor for midsize and large regional and global financial organizations. Mr. Clark has in-depth knowledge on how to integrate diverse processes into a seamless risk based audit approach that keeps audit on the cutting edge of development and value impact. His insights into the audit and risk world translate into meaningful guidance through a communication style that is fun, animated, and very participative…………more

Ray_Graber_90_112

Ray Graber
President at Graber Associates LLC

Ray Graber has a deep and thorough understanding of banking, technology, and finance. His business experience includes banking technology research and consulting at TowerGroup, best practices internet security, policies, and procedures at FleetBoston Financial, wire transfer operations and product launches at Citibank and BankBoston, and treasury operations for a $325 million public company………….more

JeFreda_Brown_90_112

JeFreda Brown
CEO of Goshen Business Group, LLC

As CEO of Goshen Business Group, LLC (formerly Brown Accounting Solutions, LLC), Ms. Brown can provide a unique suite of specialized services that are customized for an organization’s particular needs. Some of her areas of expertise include tax planning, budget preparation, DCAA audit consulting, government contract accounting system and internal controls compliance consulting, pricing proposal development, financial management, payroll compliance, business development/management consulting, professional development training, train the trainer services, business planning, grant writing, 501(c)(3) preparation, and more………….more

Lynn_Fountain_90_112

Lynn Fountain
CGMA, CRMA – Independent Risk, Audit, Accounting, Executive Professional and Training Advisor

Lynn Fountain has over 30 years of experience in the business profession, which includes public and industry accounting, and over 20 years within internal and external auditing combined. Ms. Fountain holds CGMA and CRMA certifications as well as a certificate in Certified Public Accountancy. She is a nationally recognized trainer and speaker…………..more

Craig_Spielmann_90_112

Craig Spielmann
Principal, CEO & Founder of RiskTao, LLC

Craig Spielmann is CEO and founder of RiskTao, LLC, which specializes in risk training and advisory services. He has over 30 years of operational risk management, business development, and technology and audit experience gained from working with the world’s top financial institutions (RBS, Citigroup, J.P. Morgan, Dean Witter, and Merrill Lynch)……………more

Jeffery W Johnson_90_112

Jeffery W Johnson
Senior Consultant, Bankers Insight Group

Jeffery Johnson started his career with SunTrust National Bank in Atlanta as a management trainee and progressed to vice president and senior lender for SouthTrust Bank (a large Southeastern regional bank) and senior vice president and commercial banking division manager for Citizens Trust Bank of Atlanta (community bank)…………….more

Deborah D. Linton_90_112

Deborah D. Linton
Ph.D., DL Veterinary Consulting, LLC

Dr. Linton has more than 20 years of experience in veterinary drug product development for both the US and EU. After completing degrees at Hanover College (B.A. mathematics) and Purdue University (M. S. and Ph.D., population genetics), she worked for veterinary pharmaceutical companies for 16 years at Cyanamid, Fort Dodge Animal Health, and Nexcyon Pharmaceuticals, Inc., Prior to joining Nexcyon, she was a consultant in animal health development for 10 years and returned to consultancy work in 2014. She is active in the Society of Quality Assurance, and has spoken or trained on various quality assurance, clinical trial monitoring, data validity and compliance topics within veterinary drug development……………..more

Kerri Crawford_90_112

Kerri Crawford
Associate – Norton Rose Fulbright South Africa Inc

Kerri Crawford is a technology lawyer based in Johannesburg. She joined Norton Rose Fulbright South Africa’s technology practice in 2014, having trained with the team in 2013. She focuses on the areas of data privacy, information technology and communications, e-commerce, media and broadcasting. Kerri has worked on various data privacy matters for local and international clients. She has also been involved in numerous outsourcing, licensing and services procurement and IT- specific intellectual property matters, including three multi-billion rand broadband network infrastructure projects……………..more

Tom Craig_90_112

Tom Craig
Consultant, LTD Management Inc.

Tom Craig, a real-world supply chain and logistics consultant and professional provides cutting-edge supply chain management consulting with LTD Management. He develops solutions that work for clients– manufacturers, retailers, wholesalers, global, domestic, importers, and exporters………………more

Mario Mosse_90_112

Mario Mosse
President of MMosse Consulting, LLC

Mario Mosse has over 40 years of experience in operational risk management, internal audit and regulatory compliance at financial services companies. He is the president of MMosse Consulting, LLC, where he provides risk management advice and training to the financial services industry. Previously, he was the head of operational risk management at Prudential Financial, Inc. Prior to joining Prudential, Mr. Mosse was with The Chase Manhattan Bank, where he held several senior positions in internal audit and risk management………………more

Chuck Northam_90_112

Chuck Northam
Owner, Safety Resources LLC

He has been a professional Safety Consultant for over 17 years, and been in the safety field for 27 years. He has served as a fire fighter/EMT and have been in the fire service since 1978, currently not active. He has represented safety equipment manufacturers on various products including fall protection, respiratory and confined space. He has experience helping companies with OSHA cases including expert witness testimony and working cases directly with OSHA……………..more

Charles Goredema_90_112

Charles Goredema
Senior Research Consultant – Institute for Security Studies

Charles Goredema is a senior research consultant on trends of economic crime in Africa. A lawyer by training, Mr. Goredema’s career includes a stint in the prosecution of economic crime in Zimbabwe. He was admitted to practice law in 1987. He subsequently lectured courses on criminal justice in Zimbabwe and South Africa. After joining the Institute for Security Studies in August 2000, he researched emerging forms of transnational crime and their financial dimensions. He has worked on research and capacity development projects in more than 15 African countries…………….more

Dev Raheja_90_112

Dev Raheja
Author of the books Safer Hospital Care and Preventing Medical Device Recalls

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance/Manager of Manufacturing Engineering, at Cooper Industries as Chief Engineer, and at Booz-Allen & Hamilton as Risk Management consultant for variety of industries…………….more

Gregory Pattison_90_112

Gregory Pattison
Senior Vice President, GLP Systems

Greg Pattison is a Vice President and Senior Trainer and OSHA CFR 29 1910—General Industry and 1926–Construction. Mr. Pattison was a trainer for Fred Pryor and offered general safety trainings throughout the U.S. His entertaining and informative style offer audiences knowledge that builds critical concepts and understanding to comply with the safe workplace…………….more

Gary E. Ritchie_90_112

Gary E. Ritchie
MS, Director of Scientific Affairs, InfraTrac, Inc.

Gary E. Ritchie is Director of Scientific Affairs for InfraTrac, Inc. located in Silver Spring, MD. Gary is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods including near-infrared and multivariate analysis. Gary has nineteen years of industry experience with increasing responsibility……………more

Alvaro Gutierrez_90_112

Alvaro Gutierrez
International Trade Compliance Consultant at Let’s Talk Trade, LLC

Alvaro Gutierrez has seen the word trade compliance defined numerous ways over the years. Is trade compliance a cost or a way to improve margin? Does trade compliance enhance or hinder the supply chain? Do companies need to invest in trade compliance or ignore it in order to save costs?
With over 18 years of real-life, in-the-trenches business experience, his view is radically different. Alvaro is passionate about trade compliance and enjoys sharing his knowledge and experience with an audience…………….more

Stan Mastrangelo_90_112

Stan Mastrangelo
Consultant

Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant…………….more

Vanessa G. Nelson_90_112

Vanessa G. Nelson
MSA, SPHR, CLRL

Ms. Nelson is founder and President of award-winning Expert Human Resources, which she founded to help companies maintain employment law compliance, avoid workplace litigation, reduce costs, and increase revenue. Vanessa established Expert Human Resources in 2009, after observing companies’ frustrations with complying with constantly changing employment laws as well as continually dealing with workplace litigations…………..more

Bruce Warner_90_112

Bruce Warner
CPA, and Owner – Warner Financial Group, LLC and Bear Lake Tax & Accounting

Bruce Warner is a licensed CPA in Utah and a certified depreciation professional. Since the inception of his small CPA firm over 20 years ago, Mr. Warner has served clients by providing accounting assistance and individual and business tax preparation and planning services. He was manager of financial reporting and manager of depreciation for Northwest Energy Company, located at the time in Salt Lake City, Utah…………..more

Gregory Martin_90_112

Gregory Martin
President of Complectors Consulting LLC

Gregory P. Martin is president of Complectors Consulting which provides consulting and training in the area of pharmaceutical analytical chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry and was director of pharmaceutical analytical chemistry (R&D) for a major pharma company for a number of years. In addition, he has volunteered for the USP (U.S. Pharmacopeial Convention) for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee………….more

Dr. Al Bartolucci

Dr. Al Bartolucci
Emeritus Professor of Biostatistics, University of Alabama

Dr. Al Bartolucci is Emeritus Professor of Biostatistics at the University of Alabama where he also serves as a Senior Scientist at the Center for Metabolic Bone Diseases, AIDS Research Center and Cancer Center….more

Brandy-Lewis-90X112

Brandy Lewis
Principal Quality Consultant and Director, Thirteen Consulting Group Inc

Brandy Lewis has 23 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Ms. Lewis has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models….more

Adriaan Fruijtier

Adriaan Fruijtier
Regulatory Affairs Consultant

Adriaan Fruijtier graduated as a pharmacist from the University of Utrecht, Netherlands. Until March 2004, he headed the oncology group within global regulatory affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA…more

Mark Malinowski

Mark Malinowski
Detective & President of Framework Financial, LLC

Mark Malinowski has over 16 years’ experience working in both the banking industry and as a law enforcement professional conducting financial crimes investigation, detecting fraudulent activity within public and private organizations, and designing fraud prevention programs for various business and government agencies….more

Chris Doxey

Chris Doxey
Consultant, Internal Controls and Business Process Best Practices

Chris Doxey has held senior finance and controller positions at Digital Equipment Corporation, Compaq Computer Corporation, Hewlett Packard, MCI, APEX Analytix, and BSI Healthcare. She has a bachelor’s degree in English, a bachelor’s in accounting, a master’s in business administration, and a graduate certificate in project management……more

William H. Beecken

William H. Beecken
Director of Fraud Services

William H. Beecken, CPA, CFE, MBA, is director of Fraud Services with Assurance Forensic Accounting in Atlanta, Georgia, and former federal supervisory auditor and investigator. He has a bachelor’s degree in economics from the University of the South and a Master of Business Administration degree from Brenau University…more

Kenneth-Christie

Kenneth Christie
Director of Fraud Services

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the chief operating officer for VTS Consultants, Inc….more

Dr. Richard Poser

Dr. Richard Poser
President, First Quality Inc

Dr. Richard Poser has been both receiving and conducting audits in drug, laboratory, device, software and manufacturing environments for over 25 years and teaches from personal experience…..more

Vicki Amsinger

Vicki Amsinger
Principal, Vela HR Consulting

Vicki Amsinger is a HR Consultant based in the Greater St. Louis area who has over 20 years of experience in employee communications, recruitment, training, performance management, policy development, employee relations and human resource information systems……more

Joy McElroy

Joy McElroy
Principle Consultant at Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory……more

Lee Werrell

Lee Werrell
Chartered FCSI FISMM Cert PFS

Awarded Chartered Fellowship of the Chartered Institute for Securities and Investments in 2011 Lee delivered a presentation to the British bankers Association in Jan 2013 on “Responding to a S166 Requirements Notice and managing the Risk Mitigation Program”. In the last 12 months has been involved……more

Sandra J. Hecker

Sandra J. Hecker
RAC, Regulatory Strategist and US Agent – Hecker & Associates, LLC

A biologist/biochemist by training, Sandra Hecker has more than 20 years of experience in drug and biotech development. She was on an Institutional Review Board (IRB) at NIH in the late 1980s, started the Medical……more

Andrew Bissett

Andrew Bissett
Experienced Governance and Risk Executive

ANDREW BISSETT is Commercially focused Risk professional with extensive experience in Enterprise Risk Management, Group Policy Frameworks and Corporate Governance…….more

H. David Kotz

H. David Kotz
Managing Director at Berkeley Research Group LLC

H. David Kotz is a Managing Director at Berkeley Research Group, a leading global expert services and consulting firm, and specializes in regulation of and securities trading by broker-dealers, investment advisers, hedge funds, insurance companies and banks…….more

Brian L Tuttle

Brian L Tuttle
CPHIT, CHP, CHA, CBRA, CISSP, CCNA, Net+

Brian Tuttle is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 17 years’ experience in Health IT and Compliance Consulting………more

Bart Chapman

Bart Chapman
President at OPD Consulting Group

As a board certified physician with over 30 successful years in the biopharmaceutical and medical device industry Bart Chapman MD MBA has been involved in approved NDAs, BLAs and PMAs and directing clinical trials through all phases……..more

Yvonne Ditoro

Yvonne Ditoro
RN, BSN, MBA

Yvonne Ditoro, RN, BSN, MBA is an independent pharmacovigilance operations consultant with extensive broad-based leadership in the global pharmaceutical industry in Pharmacovigilance, Quality Management Systems, Affiliate Safety Operations, Adverse Event Case Management, Compliance, Inspection Readiness……..more

Teri Morning

Teri Morning, MBA, MS, SHRM-CSP, SPHR-CA
Principal at HindsightHR

Teri Morning, MBA, MS, SHRM-CSP, SPHR-CA is the President of her own HR Consulting firm and a new company Hindsight – Employee Relations and Investigation Management software. She has over 15 years human resource, safety and training experience in a variety of professional fields, including retail, distribution………more

Richard Chamberlain

Richard Chamberlain, Ph.D,
President, Extended Clinical Services, LLC

Consulting with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of computerized project scheduling, strategic planning, Quality Management and Computer Systems Validation………more

Javier Kuong

Javier Kuong
President and Principal Consultant, Management Advisory Services & Publications (MASP)

Javier F. K., is the President and Principal Consultant of Management Advisory Services & Publications (MASP), an organization in the US that for 30 years has been devoted solely to consulting, training, publications, research and development……….more

David Harley

David Harley CFE CAMS
Director at Delta Financial Crime Consulting Pty Ltd

EXPERT David Harley CFE CAMS – is a skilled and effective Anti-Fraud, Anti-Corruption and Anti-Money Laundering professional with over 30 years’ experience preventing, detecting and resolving issues that relate to fraud, corruption money laundering and terrorist financing………..more

Harold Thibodeaux

Harold Thibodeaux
Research Investigator

Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeaux’s research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension, Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical antibiotics….more

Steven Wachs

Steven Wachs
VP and Principal Statistician

Steven Wachs has 25 years of wide-ranging industry experience in both technical and management positions. Steve has worked as a statistician at Ford Motor Company where he has extensive experience in the development of statistical models, reliability analysis, designed experimentation, and statistical process control…..more

Rayleen M. Pirnie

Rayleen M. Pirnie
AAP, CEO and Founder, RP Payments Risk Consulting Services, LLC

Rayleen is a recognized payments risk and fraud expert who works with financial institutions and businesses across the nation to help them understand today’s threats and develop appropriate risk mitigation strategies. She also speaks to consumer groups revealing real-world methods to reduce the chances of devastating frauds…..more

Elvin-Chan-90X112

Elvin Chan JD CPA CEng MBCP
Associate Director, APAC Business Continuity at Royal Bank of Canada

Elvin Chan has more than 15 years of experience in managing business interruption risks. He was awarded with Master Business Continuity Professional (MBCP) certification by Disaster Recovery Institute International (DRII) in 2009…..more