WEBINARDESK - Key Persons

Biography: Charity Ogunsanya is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO), and medical device/IVD companies. She has been a much sought-after SME to assume key roles specifically related to remediation and difficult quality and compliance-related deficiencies associated with FDA's Consent Decree, FDA's Warning Letters, and other regulatory bodies' inspectional findings. Her remediation work has constantly resulted in several successful national and international regulatory bodies' inspections, re-inspections, and new product approvals. Her technical expertise covers and goes beyond interpretation, administration, and set up of quality assurance, quality/compliance, quality engineering, aseptic processing, contamination control, quality control, microbiology, sterility assurance, stability, vaccine development, new product design, product release testing and medical device sterilization (ethylene oxide (EtO), gamma, radiation, VHP sterilization) systems and operations for compliance to various regulations. She has a keen working knowledge of the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization, and post-approval inspections. She is a member of the Parenteral Drug Association (PDA), the American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and she is currently attaining her Masters in Biotechnology (Biodefense Concentration) at the Johns Hopkins University Advanced Academic Program.

Biography: Dayna is currently the Payroll Tax & Garnishment Manager at PetSmart Inc. Dayna has been heavily involved in the payroll field over 17 years. Starting as a payroll clerk at a small Tucson company, Dayna moved on to be a Payroll Team Leader at Honeywell Inc. During Dayna's time at Honeywell she obtained her FPC (Fundamental Payroll Certification) through the American Payroll Association. She also received several merit awards for Customer Service and Acquisitions and Divestitures. Dayna is no stranger to teaching she has taught at the Metro Phoenix American Payroll Association meetings and at the Arizona State Payroll Conference. Topics including Payroll Basics, Global/Cultural Awareness, Immigration Basics for the Payroll Professional, Multi-State and Local Taxation and Quality Control for Payroll, International and Canadian payroll. Dayna has her CPP (Certified Payroll Professional) through the APA. She also serves on the National American Payroll Association on the National Strategic Leadership Task Force, Government Affairs Task Force (PA Local tax subcommittee). Dayna has received a Citation of Merit for her service along with being a Gold Pin member of the APA. Besides her payroll accomplishments Dayna is certified in HR hiring and firing practices and is a Six-Sigma Greenbelt.

Job Titles:

• CEO / Managing Partner, Active Food Safety, LLC
• Managing Partner at Active Food Safety

Dr. Hal King is Managing Partner at Active Food Safety, an Advisory Services and Digital Products company, and Founder/CEO of Public Health Innovations, a public health strategy and design company. Dr. King is also an Associate Professor of Public Health at the University of Georgia College of Public Health. Dr. King is a public health professional who has worked in the investigation of respiratory and foodborne and other disease outbreaks (at the Centers for Disease Control and Prevention, U. S. Public Health Service), performed federally funded research on the causation and prevention of infectious diseases (at Emory University School of Medicine, Division of Infectious Diseases), and worked in the prevention of intentional adulteration of foods and food defense in the United States and for Army force health (with the U.S. Army Reserves Consequence Management Unit, 20th CBRNE Command).

Biography: Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry. Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents. Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.

Job Titles:

• Principal

Biography: Jim is the Principal, James Zack Consulting, LLC, and Senior Advisor, Ankura Construction Forum™. The Forum strives to be the construction industry's resource for thought leadership and best practices on avoidance and resolution of construction project disputes globally. Formerly he was the Executive Director of the Navigant Construction Forum™ and earlier, the Executive Director, Corporate Claims Management Group, Fluor Corporation, one of the world's largest EPCM contractors. Mr. Zack was previously Vice President of PinnacleOne and the Executive Director of the PinnacleOne Institute and a Senior Construction Claims Consultant for CH2M HILL, Inc. Mr. Zack has, for more than 48years, worked on both private and public projects throughout the U.S. and in 39 countries abroad. Mr. Zack is a Fellow of AACE, Royal Institution of Chartered Surveyors, Guild of Project Controls, and Society of Construction Claims Specialists International. In the construction claims field, he is a recognized and published expert in mitigation, analysis, and resolution or defense of construction claims and disputes. Mr. Zack is a Certified Construction Manager (CCM), a Certified Forensic Claims Consultant (CFCC), an Expert Certified Construction Claims Specialist (ECCCS), an Expert Certified Construction Delay Analyst (ECCDA), and a Project Management Professional (PMP).

Job Titles:

• Founder and President of ElectroFab Sales

Biography: Michele is founder and president of ElectroFab Sales, a sales agency specializing in helping manufacturers select the right processes for their products since 1985. Michele is currently a director on the board of the American Jobs Alliance and the board of the San Diego Inventors Forum. She was Chair of the California chapter of the Coalition for a Prosperous America from 2013-2018. Michele earned a B. A. from San Diego State University and a certificate in Total Quality Management in 1993. She is a 1994 graduate of San Diego's leadership program (LEAD San Diego) and earned a Yellow Belt Certificate in Lean Six Sigma in 2014. She is the author of three books, the latest being Rebuild Manufacturing - the key to American Prosperity, which is a sequel to the 2012 edition of Can American Manufacturing Be Saved: Why we should and how we can. She has been a blogger for Huff Post, Industry Week, and other newslines and currently blogs for www.themadeinamericamovement.com. She is an authorized speaker for the Reshoring Initiative.

Job Titles:

• Certified Public Accountant
• Crypto Currency and Taxes
• DBA, CPA, CFE, Cr. FA, CVA, MAFF, CFF, CGMA, PI
• President and Owner of Minniti

Dr. Minniti is the President and Owner of Minniti CPA, LLC. Dr. Minniti is a Certified Public Accountant, Certified Forensic Accountant, Certified Fraud Examiner, Certified Valuation Analyst, Certified in Financial Forensics, Master Analyst in Financial Forensics, Chartered Global Management Accountant, and is a licensed private investigator in the state of Arizona. Dr. Minniti received his doctoral degree in business administration from Walden University, received his MBA degree and Graduate Certificate in Accounting from DeVry University's Keller Graduate School of Management, and received his Bachelor of Science in Business Administration degree from the University of Phoenix. Dr. Minniti taught graduate and undergraduate courses in forensic accounting at DeVry University, Grand Canyon University, Kaplan University, Northwestern University, and the University of Phoenix. He designed graduate and undergraduate courses for Grand Canyon University, Northwestern University, and Anthem College. He is a writer and public speaker. He has experience in forensic accounting, fraud examinations, financial audits, internal audits, compliance audits, real estate valuations, business valuations, internal control development, business continuation planning, risk management, cybersecurity, privacy laws, data security, Sarbanes-Oxley compliance work, and business consulting. In addition to his practice, Dr. Minniti is an instructor teaching continuing professional education classes for a variety of providers and CPA Societies. Dr. Minniti is currently serving as a board member on the National Association of Certified Valuators and Analysts (NACVA) Litigation Forensics Board (LFB) and as a committee member on the Arizona State Board of Accountancy's Law Review Advisory Committee.

Job Titles:

• Principal Associate and Director of Citadel Advantage Ltd

Stanley is a Principal Associate and Director of Citadel Advantage Ltd., Since 2001 Citadel Advantage has been working with banks and financial institutions to make them safer and more profitable, through consulting and training, specifically in the key areas of Governance, Risk Management, and Compliance. Stanley has over 40 years of banking and IT experience, 33 of which were with the Standard Bank of South Africa where during the 1990s he filled an industry-level role holding several key positions including that of Chairman of the PASA Risk Committee. He also represented South Africa at two sessions, in New York, of UNCITRAL (the United Nations Commission on International Trade Law). He holds a Master's Degree in Economics and a Bachelor of Commerce (BCom.) degree, both from the University of South Africa, Pretoria. Stanley has had extensive exposure to banking practice and banking operations in a number of countries including the USA, United Kingdom, South Africa, Israel, Europe, and Australia. He has also acted as advisor to a number of central banks on payment systems, oversight, policy, and payments risk issues. More recently, he spent time in the high-tech sector as a payment systems designer and consultant to a global payments software developer

Job Titles:

• 6 - Hour Virtual Seminar on Payroll Virtual Boot Camp: Wage and Hour
• Fair Labor Standards Act: Wage and Hour Compliance for 2021
• Going Paperless in Payroll in 2021
• Payroll Overpayments: Handling Them Correctly in 2021
• Wage and Hour Compliance: Its More Than Just Calculating Overtime
• Year - End Payroll: Close Out 2020 With Confidence - and Prepare for 2021