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  • Aseptic Technique Understanding and Cleanroom Behavior - 2017

    Overview: Compounding sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. Why should you Attend: This course will review proper cleaning, gowning and ways to avoid the common sources of contamination that exist in a clean room environment. Areas Covered in the Session: In sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It is providing sterility, safety, and efficacy to the sterile product, especially various injections for patients. Who Will Benefit: Aseptic Operators Aseptic Sample Handlers Personnel who work in a Biological Safety Cabinet Speaker Profile: Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com

  • Latest FDA Changes to the Process Bullet Proof 510k - 2017


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  • HACCP Workshop (Advanced)

  • Certified Food Safety HACCP Manager Review

    The Exam for this Workshop will be held on July 28.

  • Control Change in Medical Device Engineering - 2017

    Overview: This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. Why should you Attend: FDA and ISO call for change control but do not provide any further guidance as to how to create a compliant system. The situation gets complicated when a company has suppliers or contract manufacturers and changes and approvals must pass from one to the other. Areas Covered in the Session: Change control procedure Pre release and post release change control Change transfer between company and suppliers Forms and SOP's Who Will Benefit: Development Engineers Production Management QA/ QC Personnel Engineering Management Regulatory Personnel Speaker Profile: Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com

  • Cyber Attacks, Beyond Disaster Recovery - 2017

    Overview: Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the grim reality that a cyber-attack is inevitable. It's not a matter of if an attack will occur, only when. Why should you Attend: A poor response is often more damaging that the cyber-attack itself. According to recent reports, cyber-attacks cost the average American business $15.4 million per year, double the global average of $7.7 million. Areas Covered in the Session: Cost of a cyber-crime How a Cyber Incident Response Plan differs from a Disaster Recovery Plan Components of a Cyber Incident Response Plan Plan testing Cyber Incident Response Team Development and obligations Incident communications Evaluating solution provider Plans Who Will Benefit: Risk Manager Information Security Management Operations Speaker Profile: Rayleen M. Pirnie is the founder and owner of RP Payments Risk Consulting Services, LLC. based in Missouri. She is a nationally recognized payments risk and fraud expert who offers specialized consulting services, procedural and risk management reviews, and payments education. Rayleen’s specialized skill is delving into the world beyond the payment rules; areas where organizations often find themselves in positions of liability or loss with little to no clear guidance. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Effective Supplier Qualification Program - 2017

    Overview: FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct. FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns. Areas Covered in the Session: Learn the pre-selection, selection and assessment process through the use of various tools Methods, techniques and strategies that work and are proven with supplier relations and qualification Learn how to apply risk-based approaches and why and how to "rank" suppliers Supplier Agreements, Quality Agreements and other documentation including Audits/Assessments Who Will Benefit: QA/QC/Compliance/Regulatory Affairs Engineering/R&D/Technical Services Purchasing/Procurement/Sourcing Consultants Speaker Profile: David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Microbiology and Food Safety Course

    • Date August 4, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Green Bay, WI
    • Website http://fsns.com/

    Sponsored by Food Safety Net Services (FSNS)

  • Achieving Compliance Excellence - 2017

    Overview: We will discuss each of those keys in detail to enhance understanding and to provide the needed information to replicate the approach in your organization. Why should you Attend: Because as much as we try, most regulated industries don't have a set approach for developing a compliance program that is integrated into the fabric of their organization, that serves real valuable functions to improve operations, improve and maintain human competence, and enhance competitiveness. Areas Covered in the Session: Defining your Critical Processes and why that is important The Benefits of Developing Sound Regulatory Documentation Why Harmonizing your Processes is Critical to Consistency in Operations and Regulatory Compliance Who Will Benefit: Directors Managers Scientists Technicians Associates Speaker Profile: 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. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Validation Program to a Building from Top to Bottom - 2017

    Overview: Many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build a sustainable validation program. Why you should attend: How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program. Areas Covered In the Session: Discuss what FDA is really looking for in process validation Specify the deliverables associated with software validation Common pitfalls to avoid when executing validation protocols How to estimate costs and time associated with validation Who will benefit: Internal Auditors Senior Management Compliance Officers QA Managers QC Managers Purchasing Managers Speaker Profile: Jonathan M. Lewis has over twenty-two years’ experience in the areas of executive management, quality control (QC), quality assurance (QA), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, dietary supplement, food, and animal food industries. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • FDA Inspection and Respond to 483 & How to Prepare them - 2017

    Overview: In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection. Why should you Attend: FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter. Areas Covered in the Session: Personnel Preparation Facility needed to support inspection Behavior during inspection-what not to sign Internal/ Mock audits 483 response Who Will Benefit: Engineering Personnel Engineering Management Quality Management Corporate Management Manufacturing Management Division Management Speaker Profile: Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • CAPA within a Device Quality System - 2017

    Overview: You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you. Why should you Attend: Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And yet, many medical device manufacturers struggle to establish and maintain and effective CAPA process. Areas Covered in the Session: FDA and NB expectations for CAPA Lessons Learned from 483s and warning letters Common problems CAPA How to structure your CAPA process How to use IT tools to monitor and maintain your CAPAs Metrics to ensure your CAPAs are timely and effective A toolkit for CAPA Best Practices Who Will Benefit: Quality Systems Specialists Document Control Specialists Quality and Compliance Specialists Internal Auditors and Managers Training Specialists CAPA Specialists Speaker Profile: Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Environmental Monitoring Program at FDA Regulations - 2017

    Overview: Upon completion of this training, you will be able to Describe how Clean room Environmental Monitoring Program fits into the Regulations. Explain the basis of the Four (4) Phases of Clean room transitional monitoring. 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 Cleaning Validations of your manufacturing equipment? Areas Covered in the Session: Applicable Regulations - Where does the EM Program fit in the Regulation? - Role of Clean room Environmental Monitoring Program? Basics of Setting a Robust and Effective EM Program - Key Considerations - Relevant Material Verification Processes - Steps and Content of an EM Program Testing Procedure Who Will Benefit: Quality Control, Quality Assurance Microbiologist, Facilities Chemist, Analysts Manufacturing 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
  • Laboratory-Developed Tests - Medical devices 2017

    Overview: This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. Why should you Attend: This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laboratory community, and others. Areas Covered in the Session: "Enforcement Discretion" and how it has been applied to LDT regulation Extent of CLIA '88 authority over LDT performance Role of US Congress in answering the question of FDA authority International (EU) approach to LDTs Who Will Benefit: QA Specialist Complaint Coordinator Regulatory Specialist QA Manager QA Trainer All above in Medical Device companies Speaker Profile: Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • ISO 14971 Hazard Analysis at Medical Device - 2017

    Overview: The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Why should you Attend: FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced. Areas Covered in the Session: Explanation of Hazard Analysis terms Hazard analysis Process explanation using a template Examples of terms will be given Hazard analysis examples will be covered step by step Who Will Benefit: Engineer Engineering Manager Regulatory Personnel QA Speaker Profile: Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Introduction to Food Science Course

    Rutgers University invites you to transform, broaden and update your food science skills with this highly focused, practical training! Get the Best of a 4-Year Food Science Education in Only 5 Days!
  • Reshaping your HACCP Plan with Preventive Controls

    • Date August 22, 2017 – August 24, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Columbus, OH
    • Website http://fsns.com/

    Sponsored by Food Safety Net Services (FSNS)

  • Medical Devices for Risk Management Techniques 2017

    Overview: This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them. Why should you Attend: Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks. Areas Covered in the Session: Overview of the ISO14971 standard as it applies to medical device companies Integrating the new standard with ISO 13485 as part of your overall QMS Conducting a review of the intended use of your device Stages of Risk Management as well as Tools and Techniques Judging the probability that harm may occur from those hazards Who Will Benefit: Design Engineer Manufacturing Engineer Quality Engineer R&D Personnel R&D Project Managers Quality Managers Auditors Regulatory Affairs Specialist R&D Manager Speaker Profile: Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
  • Argentine Food Safety Commission 2nd Symposium 2017

    • Date August 23, 2017 – August 24, 2017
    • Time 12:00 AM - 12:00 AM
    • Location Buenes Aires, Argentina
    • Website

    For more information on this meeting, contact Fabiana Guglielmone at fabiana.guglielmone@unilever.com.

  • FSPCA Preventive Controls for Human Food (PCQI)