Manufacturing Skills - Management

The attendees will learn how to leverage best practices across all systems by creating a standardized program for FDA data governance. 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/Data-Governance-for-Computer-Systems-Regulated-by-FDA-502212/MAY-2018-ES-TRAININGREGISTRY

Importance of regulatory and testing requirements of products for compliance by applying sequential steps in testing product to rule out presence of Endotoxin. 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/Regulatory-and-Testing-Requirements-of-the-Bacterial-Endotoxin-Testing-BET-or-LAL-Program-507758/MAY-2018-ES-TRAININGREGISTRY

This webinar will help you have an understanding of successful Test Method Validation and the detailing of real-life case studies. 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/Scrutinizing-Test-Method-Validation-TMV-to-Verify-the-Performance-of-a-Medical-Device-504196/MAY-2018-ES-TRAININGREGISTRY

Attend this webinar to learn how the new FDA Guidance on Elemental Impurities is related to ICH Q3D and USP Chapters 232 and 233. 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/New-Elemental-Impurities-Tests-for-Pharmaceutical-Products-According-to-the-New-ICH-Q3D-and-USP-232-233-Guidelines-505938/MAY-2018-ES-TRAININGREGISTRY

The attendee will gain an understanding of the importance of conducting an investigation and measuring the effectiveness of CAPAs. 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/Ensuring-Data-Integrity-in-Investigations-504603/MAY-2018-ES-TRAININGREGISTRY

The 2-day seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality. Statistical Process Control

FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions.

Overview: This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Why should you Attend: This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.

Overview: In this webinar, we will review CAPA as part of Quality Management System (QMS), reasons why organizations need to use CAPA, what is its purpose. We will describe CAPA concepts and procedures. We will also describe FDA investigation procedure of CAPA. Why should you Attend: Corrective and preventive actions both include stages for investigation, action, review, and further action if required. Implementation of corrective and preventive actions is the path towards improvement and effectiveness of Quality Management Systems.

Gain a clear understanding of what FDA inspectors look for when evaluating complaint handling and medical device reporting programs. 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/GMP-Complaint-Systems-FDA-s-Adverse-Event-Reporting-Product-Recalls-502220/APRIL-2018-ES-TRAININGREGISTRY

The attendees will learn how to leverage best practices across all systems by creating a standardized program for FDA data governance. 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/Data-Governance-for-Computer-Systems-Regulated-by-FDA-502212/APRIL-2018-ES-TRAININGREGISTRY

Attendees will learn the fundamentals for reviewing batch records in a pharmaceutical environment. 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/Efficient-and-Effective-Batch-Record-Reviews-to-Improve-your-Process-Capabilities-505980/APRIL-2018-ES-TRAININGREGISTRY

Training program on onboarding process in GMP environment. Learn how to differentiate the training requirements for full-time employees and contractors. 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/Onboarding-Employees-in-a-GMP-Environment-Best-Practices-for-Foundational-Employee-Success-506161/APRIL-2018-ES-TRAININGREGISTRY

This webinar focus on effective organizational downsizing strategies as well as the impact on employees who are laid off or those employees who remain. 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/Downsizing-Best-Practices-and-Beyond-509200/APRIL-2018-ES-TRAININGREGISTRY

Attend this webinar to know the theory of lean documents and lean configuration to present a fresh approach to linked and cascading documents, files, and 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/Risk-Management-Utilizing-Lean-Documents-and-Lean-Configuration-507585/APRIL-2018-ES-TRAININGREGISTRY

Learn how importers need to be aware about the new drawback regime and resulting refunds. 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/U-S-Customs-Duty-Drawback-Refunds-Understanding-the-Recent-Changes-505997/APRIL-2018-ES-TRAININGREGISTRY

Understand how purchasing and acceptance activities are linked and combine to facilitate effective supplier management 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/Acceptance-Activities-in-FDA-s-Quality-Management-System-507314/APRIL-2018-ES-TRAININGREGISTRY

This webinar will examine current medical device registration requirements in Brazil and recent regulatory changes. 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/Understanding-the-Brazilian-Regulatory-Environment-for-Medical-Devices-506563/APRIL-2018-ES-TRAININGREGISTRY

This process capability webinar will show how to handle situations in which the distribution is not a bell curve. 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-When-It-s-Not-a-Bell-Curve-505754/APRIL-2018-ES-TRAININGREGISTRY

Learn an overview of the status of GMO's in the US, FDA's policy on GMOs, FDA's biotechnology policy and consultation program and global GMO labeling regulations.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/USDA-GMO-Labeling-What-to-Expect-from-the-2018-Final-Rule-503432/APRIL-2018-ES-TRAININGREGISTRY