Quality & Reliability

LEARNING OBJECTIVES • Understand human error: factors and root causes. • Understand the importance of human error reduction: regulatory and business. • Define the process to manage Human Error deviations. • Identify root causes associated to human error deviations. • Learn how to measure human error rates at your site. • Identify how to control human error and what I can do to support human reliability. WHO WILL BENEFIT • Training managers and coordinators • Operations • Manufacturing • Plant engineering • QA/QC staff • Process excellence/improvement professionals • Industrial/process engineers • Compliance officers • Regulatory/legislative affairs professionals • General/corporate counsel Use Promo Code SPRS20 and get flat 20% discount on all purchases. To Register (or) for more details please click on this below link: http://bit.ly/2TeStAa Email: support@trainingdoyens.com Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882

OVERVIEW FDA requires that all documentation related to GxP products (GMP, GLC, GCP) be created and maintained in accordance with specific rules. From the color of the ink used to the retention requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation. The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation guidelines, deliverables and how to document them. Use Promo Code XMSNY19 and get flat 20% discount on all purchases. To Register (or) for more details please click on this below link: http://bit.ly/36Hyoqu Email: support@trainingdoyens.com Toll Free: +1-888-300-8494 Tel: +1-720-996-1616 Fax: +1-888-909-1882

Learn to determine what why and how of non conformances occurring in the laboratory. Register now. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Root-Cause-Analysis-RCA-in-the-Laboratory-Addressing-Non-Conformances-509217/JULY-2019-ES-TRAININGREGISTRY

This course will explain how to utilize risk-based quality tools to determine supplier classification. An example supplier risk assessment will be reviewed during the course. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Establishing-a-Robust-Supplier-Management-Program-508398/JULY-2019-ES-TRAININGREGISTRY

Learn how to prepare for an FDA inspection and how to behave during one by attending this webinar by Dr. Loren Gelber. Register Today. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -https://www.onlinecompliancepanel.com/webinar/How-to-Prepare-for-FDA-Inspections-and-Customer-Audits-of-Pharmaceuticals-505331/May-2019-ES-TRAININGREGISTRY

This webinar will help you have an understanding of successful Test Method Validation and the detailing of real-life case studies. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -https://www.onlinecompliancepanel.com/webinar/Test-Method-Validation-to-Verify-your-Device-Performance-503591/May-2019-ES-TRAININGREGISTRY

Learn about elemental impurities either through thorough risk assessments or through testing. And it will provide an understanding of the standards and guidelines. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Elemental-Impurities-Tests-for-Pharmaceutical-Products-according-to-the-ICH-Q3D-and-USP-232-233-Guidelines-507031/APRIL-2019-ES-TRAININGREGISTRY

Attend this webinar to learn the most important areas of medical device safety and how complaint handling and CAPA process is used during FDA inspections. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Medical-Device-Complaints-CAPA-506097/APRIL-2019-ES-TRAININGREGISTRY

Learn all the new SFCR rules which focus on food safety needs along with avoiding penalties by complying with the regulations. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/New-Safe-Foods-for-Canadians-Regulation-508013/APRIL-2019-ES-TRAININGREGISTRY

This webinar will provide valuable guidance on how to use extraction techniques to validate the cleanliness of a device. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Cleaning-Validations-Using-Extraction-Techniques-504912/MARCH-2019-ES-TRAININGREGISTRY

Learn the key differences between NAFTA and USMCA, legal requirements, and the custom clearance process. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/From-NAFTA-to-USMCA-Key-differences-505468/MARCH-2019-ES-TRAININGREGISTRY

This session will provide you information with procedures for controlling electronic signatures and electronic records and how 21 CFR Part 11 is connected with this area. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/21-CFR-Part-11-Electronic-Record-and-Signature-Validation-509394/MARCH-2019-ES-TRAININGREGISTRY

This webinar is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/QbD-Approach-to-Analytical-Method-Lifecycle-Design-Development-Validation-Transfer-504438/MARCH-2019-ES-TRAININGREGISTRY

This course provides guidance on tools to plan and execute test method validation and transfer also a comprehensive overview of the international regulatory authority requirements. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Analytical-Method-Validation-and-Transfer-506228/MARCH-2019-ES-TRAININGREGISTRY

Get an overview of the regulations as they pertain to the manufacturing, marketing, distribution and other operational activities engaged by companies in the tobacco industry. This course will describe the best practices for developing a compliance strategy, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.Price:$150.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Tobacco-Industry-Trends-for-Computer-Systems-Regulated-by-FDA-508423/JANUARY-2019-ES-TRAININGREGISTRY

Due to the variety of differences in the definition of case management and roles and functions, there is much confusion in the field as to what case management is and how it is applied. Without a national perspective on this issue, many case management departments are not designed to respond to the challenges of health care reform. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Best-Practice-Case-Management-Roles-and-Functions-How-to-Optimize-RN-and-Social-Worker-Skill-Sets-504932/NOVEMBER-2018-ES-TRAININGREGISTRY

Regulatory expectations are clear about manufactures' responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standards, maintain compliance to regulatory requirements and consistently meet established expectations Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Establishing-a-Robust-Supplier-Management-Program-505529/NOVEMBER-2018-ES-TRAININGREGISTRY

This webinar discusses methods for estimating process capability for both normal and non-normal data. Pre-requisites for estimating process capability (e.g. establishing process stability) are discussed first. Distributions are briefly described and methods for estimating ppm levels are presented. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Process-Capability-Assessment-for-Normal-and-Non-Normal-Data-503555/NOVEMBER-2018-ES-TRAININGREGISTRY

FDA inspections look for noncompliance with applicable manufacturing regulations. During the inspection the FDA investigator makes a "list of observations" that gives examples of violations. The list is known as the "483." Some observations are very serious and can easily lead to receiving a Warning Letter, which threatens legal action. Your response to a 483 plays a critical role in how the agency will evaluate the inspection. A poorly written response or not responding at all will certainly lead to a Warning Letter and follow up action by FDA. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Managing-the-FDA-form-483-Inspection-Observations-503502/SEPTEMBER-2018-ES-TRAININGREGISTRY

This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer, report, or otherwise manage data that will be submitted to FDA and/or must be available for FDA review upon inspection or audit. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Mobile-Applications-and-Computer-Systems-Regulated-by-FDA-508531/SEPTEMBER-2018-ES-TRAININGREGISTRY