Manufacturing Skills - Management

This webinar will present use of Hatto (sudden awareness) report, stakeholder-initiated CAPA to drive improvement. 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/The-Hatto-Sudden-Awareness-Report-Use-Stakeholder-Initiated-CAPA-to-Drive-Improvement-507502/FEBRUARY-2019-ES-TRAININGREGISTRY

This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach. 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/Implementing-the-ASTM-E2500-Validation-Method-509460/FEBRUARY-2019-ES-TRAININGREGISTRY

Know the basics of GMPs for any medical marijuana production operation, so that your unit is fully compliant when cannabis is federally recognized. Live Webinar. 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/GMP-s-for-Medical-Marijuana-Insight-into-Manufacturing-Labeling-Tracking-and-Disposal-requirements-505324/JANUARY-2019-ES-TRAININGREGISTRY

Understand regulatory requirements for batch record review and what to look for while reviewing batch records. Register for this webinar today. 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/Efficient-and-Effective-Batch-Record-Reviews-to-Improve-your-Process-Capabilities-506336/JANUARY-2019-ES-TRAININGREGISTRY

Understand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for software enabled Medical Devices. Enroll for the webinar today. 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/IEC-62304-for-Medical-Device-Software-502216/JANUARY-2019-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

Overview: Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them. You'll learn techniques that can help you identify hazards and potential harms. You'll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products.

This webinar will cover the OSHA Requirements for Implementing a Noise Conservation Program. This webinar will cover in detail why hearing loss occurs and what can be done to prevent it - both on and off the job. 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/OSHA-Requirements-of-Implementing-a-Noise-Conservation-Program-509358/SEPTEMBER-2018-ES-TRAININGREGISTRY

This webinar will discuss the Consideration of IQ, OQ, and PQ and their equivalents for processes, equipment (production and test), product, and cGMP e-records / e-signatures. IQ/OQ/PQ validations deliver evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. 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/IQ-OQ-PQ-in-the-Verification-and-Validation-Process-508676/SEPTEMBER-2018-ES-TRAININGREGISTRY

This FDA audit webinar will highlight the purpose of FDA audits and scope, understanding of QSIT audit and how to develop an audit preparedness plan. It will also give understanding of what the FDA will look for at the conclusion of your audit and how to communicate with FDA before and after the 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/Regulatory-Inspections-How-to-prepare-for-a-visit-from-an-FDA-auditor-506970/SEPTEMBER-2018-ES-TRAININGREGISTRY

This webinar will explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance, and the difference between real human error and systems, process, and management deficiencies. 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/Human-Error-Prevention-in-Pharmaceutical-Manufacturing-503932/SEPTEMBER-2018-ES-TRAININGREGISTRY

Learn how to write SOP and work instructions and explore the true purpose and function of compliance documents. 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/Applying-Global-Standards-to-Life-Sciences-Compliance-Documentation-504874/AUGUST-2018-ES-TRAININGREGISTRY

Learn the complexity, issues and solution for designing and implementing a stability program for large molecule therapeutics. 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/Implementing-a-Stability-Program-for-a-Biologic-508572/AUGUST-2018-ES-TRAININGREGISTRY

Attend this webinar to understand what international regulations should be referenced, ISO classification of rooms and how it should be applied and more. 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/Auditing-for-Microbiological-Aspect-of-Pharmaceutical-and-Biopharmaceutical-Manufacturing-503200/AUGUST-2018-ES-TRAININGREGISTRY

Understand the validation and regulatory requirements for the sterile filtration of pharmaceutical products. 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/Sterile-Filtration-of-Pharmaceutical-Products-Validation-and-Regulatory-Requirements-502453/AUGUST-2018-ES-TRAININGREGISTRY

Attend this webinar to gain an appreciation of the regulatory CMC and use of inactive ingredients manufactured from various firms. 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/Discussion-Regarding-the-Substitution-of-a-New-Inactive-Ingredient-in-an-Approved-Parenteral-Drug-Product-505414/JULY-2018-ES-TRAININGREGISTRY

Learn 21 CFR subpart J of FDA regulations related to CAPA, how to integrate CAPA with other branches of QMS. 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/CAPA-Simplified-A-One-Form-Easy-To-Complete-Method-for-Simplifying-Your-CAPA-Process-507402/JULY-2018-ES-TRAININGREGISTRY

This webinar provides information that will identify and correct common issues that may arise during validation of methods required in drug development. 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/Common-Problems-and-Mistakes-in-Method-Validation-in-Drug-Development-Process-505094/JULY-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 Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations

Discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination. 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/Microbiological-and-Business-Risk-of-Not-Testing-Raw-Materials-for-Microbial-Presence-505482/JULY-2018-ES-TRAININGREGISTRY