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  • Analysis and Risk Assessment of Listeria in Frozen Foods

  • Foreign Supplier Verification Programs (FSVP)

  • Singapore Seminar on FDA Data Integrity for Computerized Systems

    Overview: The Problem: We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following? • Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News • Overview and Key Requirements of Part 11 & Annex 11 • How to use a Risk Based Assessment to reduce work while still achieving Data Integrity and Compliance? • How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity? I often refer to 21 CFR 11 and Annex 11 as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement Data Integrity, it is often very hard to apply requirements for DATA INTEGRITY to computerized system, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the agencies have stepped up data integrity inspections and the number of citations on the subject is skyrocketing! This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity. This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. What is Data Integrity and how is it implemented 2. How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance? 3. Data Integrity Frequently Asked Questions 4. Validation Master Plan 5. Risk Based Assessment 6. Complete Validation for a System (software development lifecycle) 7. Automated Test Tools 8. Infrastructure Requirements 9. Change Control 10. SOPs Who will benefit: • VP of IT • Director of IT • Quality Managers • Project Managers (for DATA INTEGRITY / IT) • Validation Specialists • Database Administrators • System Administrators • Directors / Senior Directors of Discovery • Directors / Senior Directors of Development • Directors / Senior Directors of Commercialization • Document Managers • Training Managers • Consultants • Data Managers • Safety Managers Agenda: Day 1 Schedule Day 1 Schedule Lecture 1: Introduction / Background • Introductions / Participants' Understanding • Participants' Objectives for the Course (Please come prepared to discuss) Lecture 2: Data Integrity • What is Data Integrity • How is it implemented • Data Integrity Frequently Asked Questions Lecture 3: 21 CFR 11 & Annex 11 • 21 CFR 11 • Annex 11 • 21 CFR 11.10(a) - Computer Systems Validation Lecture 4: Risk Assessment & Requirements • Risk Assessment for Requirements • Gathering Requirements • Entity Relationship Diagram • Process Decomposition • Exercise on how to create Requirements • SOPs Day 2 Schedule Lecture 1: Design • Design Specifications • Software Configuration and Build • Exercise on how to create Design Specifications Lecture 2: Verification & Testing • Traceability Matrix • Verification and Testing • Other Documents Lecture 3: Special Topics • Test Tools for DATA INTEGRITY • Infrastructure Requirements Lecture 4: Change Control & SOPs • Change Control Speaker: Angela Bazigos CEO, Touchstone Technologies Silicon Valley 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. Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Executive Education in Life Sciences and on the Stanford Who's Who Registry for contributions to the Lifescience industry. Location: Singapore Date: April 24th & 25th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Mandarin Orchard Singapore Address: 333 Orchard Road, Singapore 238867 Tel: (65) 6235 7788 Price: Price: $1,695.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)* Until March 10, Early Bird Price: $1,695.00 from March 11 to April 22, Regular Price: $1,895.00 Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900946SEMINAR?channel=mailer&camp=seminar&AdGroup=foodprotection_april_2017_SEO Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel
  • HACCP Training Course

    • Date April 25, 2017 – April 26, 2017
    • Time 12:00 AM - 12:00 AM
    • Location San Antonio, TX
    • Website http://fsns.com/

    Sponsored by Food Safety Net Services (FSNS)

  • Analytical Method Validation in FDA process - 2017

    Overview: An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle. Why should you Attend: Observations that test methods are inadequate or the firm does not have appropriate data that demonstrates the method performs as intended rank high on the list of observations in the laboratory. Areas Covered in the Session: FDA System Based Inspection Guidance Laboratory Control System Most common observations in the laboratory Warning letter observations and analysis Who Will Benefit: Quality Control Manager Supervisors Analysis and Microbiologists Speaker Profile: John (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Goldratt's Theory of Constraints - 2017

    Overview: This applied to his logistics system, which another reference depicted as a "continent spanning conveyor," but continuous flow in his factories achieved the same purpose at the manufacturing level. This, and the relatively low inventories carried in the chemical process industries, shows that it is quite possible to go beyond the Theory of Constraints by looking for ways to eliminate variation in processing and material transfer times. Why should you Attend: No manufacturing process can work faster than its slowest operation, the constraint or capacity-constraining resource. This carries over into project management where no project can finish more rapidly than the events on its critical path. The implications in manufacturing include longer cycle times and more inventory, both of which make it more difficult to meet customer demands. Areas Covered in the Session: The constraint or capacity-constraining resource (CCR) limits the throughput of a manufacturing process just as the critical path defines the minimum time in which a project can be completed. Variation in processing and material transfer times will reduce throughput because time lost at the constraint can never be recovered favorable variation does not offset unfavorable variation. Who Will Benefit: Manufacturing Managers Engineers Supply Chain Professionals Project Management Professionals Speaker Profile: William Levinson is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He holds degrees in chemistry and chemical engineering from Penn State and Cornell Universities, and night school degrees in business administration and applied statistics from Union College, and he has given presentations at the ASQ World Conference, TOC World 2004, and other national conferences on productivity and quality. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Lean Documents and Lean Configuration - 2017

    Overview: The webinar will first present the key differences between ISO 13485 2015 versus ISO 13485 2003.Next, the speaker will provide an overview of the updated standard. Why should you Attend: This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices. Areas Covered in the Session: ISO 13485 2015 versus ISO 13485 2003 Overview of ISO 13485 2015 Systemic Requirements Management Requirements Resource Requirements Realization Requirements Remedial Requirements Who Will Benefit: Managers, Supervisors, Directors, and Vice-Presidents R&D Manufacturing Engineering Design Assurance Quality Assurance Operations Document Control Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com Speaker Profile: Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Project Management Business Administration - 2017

    Overview: This course begins with general principles of Project Management Business Administration (PMBA) and continues to elaborate on specific topics relevant to pre-bid scenarios, execution phase strategies, and close out dilemmas. Why should you Attend: Do you know how many successful projects it takes to cover the loss from one bad project? Do you understand the stress on a company when a project does not have positive cash flow? Do you want to be sure that when layoffs come around, that you are kept on board? Areas Covered in the Session: How to identify threats and opportunities during all stages of a project How to leverage your project performance into job opportunities How to translate execution strategies to individual accountability How to mitigate claims and litigation How to sell your clients for future projects How to make yourself priceless to your company Who Will Benefit: Project Managers Assistant Project Managers Project Directors Program Managers Project Executives Speaker Profile: Heath Suddleson has more than 25 years managing projects in the design and construction industry where he has led teams in managing billions of dollars worth of projects. In these roles, Heath has served as the Contractor, the Architect/Engineer, and even represented the Owner. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Food Defense Workshop

  • Regulatory Compliance by Implementing the Cost Effectively - 2017

    Overview: This webinar will introduce and overview the concept of containing compliance costs - working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. Why should you Attend: What is the result or impact of the regulatory environment on the business? Companies find themselves in the position of doing too little or too much relative to compliance because they are simply not sure. Too little in terms of compliance makes you vulnerable to the FDA's auditing/checking function opening your company to a varying array of sanctions that could significantly impact your business. Areas Covered in the Session: Regulatory compliance cost containment overview Effective compliance documentation - operations, compliance, & training Internal/independent audits Quality by Design Harmonizing your processes Effectively handling FDA inspections Who Will Benefit: Team Leaders Managers Directors Senior Directors Vice Presidents Speaker Profile: Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex regulatory, training and documentation issues. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • FDA Regulations for Qualification and Validation Processes - 2017

    Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Why Should You Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? Areas Covered in the Session: Requirements and approaches for Analytical Instrument Qualification Risk based validation approach Going through the qualification phases User requirements, writing the specifications Who Will Benefit: Laboratory managers, supervisors and analysts IT managers and staff Consultants Laboratory suppliers of material, equipment and services Senior quality managers Speaker Profile: Joy McElroy 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 role at Abbott Laboratories where she oversaw their Quality Control Lab. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • 3-A Annual Meeting

    • Date May 1, 2017 – May 4, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Minneapolis, MN
    • Website http://www.3-a.org
  • 3-A SSI 2017 Education Program and Annual Meeting

    • Date May 1, 2017 – May 4, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Bloomington, MN
    • Website http://www.3-a.org
  • 3A 2017 Education & Annual Meeting

    • Date May 1, 2017 – May 4, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Hilton Minneapolis/St. Paul Airport, Bloomington, MN
    • Website http://www.3-a.org
  • How to Meet FDA QSR and ISO 13485 Requirements - 2017

    Overview: A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Why should you Attend: This presentation will review the QSR and ISO requirements for supplier evaluation and assessment. It will also provide cost efficient and equally compliant options for many of the most common practices in supplier management programs. Areas Covered in the Session: QSR and ISO requirements for supplier selection QSR and ISO requirements for supplier assessment. Recommended processes for new supplier qualification in a cost efficient manner. Who Will Benefit: Supply chain management Purchasing management Regulatory management QA management Executive Management Speaker Profile: Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com

  • FSPCA Preventive Controls for Human Food (PCQI)

  • Microbiology and Food Safety Course

    • Date May 2, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Fresno, CA
    • Website http://fsns.com/

    Sponsored by Food Safety Net Services (FSNS)

  • Associated Illinois Milk, Food and Environmental Sanitarians 2017 Spring Conference

    • Date May 3, 2017 – May 4, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Bloomington, IL
    • Website http://www.aimfes.org
  • New Jersey Association for Food Protection Spring Seminar

  • Seminar on Re-Assessing Macronutrient Needs - Requirement, Quality and Health Impact

    ILSI Southeast Asia Region is hosting a 1 1/2 day seminar to provide an overview of the most recent scientific knowledge and research findings on current and optimal macronutrient intakes, and to discuss the implications for dietary recommendations in the ASEAN region. The seminar targets nutrition and health professionals from government departments and agencies; academia; research organizations; and food industries.