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
In this webinar we stress the project manager integration roles: how their product integrates to the customer's suite, how their team integrates into the operational staff, and how new technology integrates with their product. 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/Integration-Management-The-Project-Managers-Key-Role-504229/SEPTEMBER-2018-ES-TRAININGREGISTRY
This training on residual solvents will discuss the regulatory landscape for residual solvents and compliance requirements, including interpretation of the majors' sections (classes of solvents, options for describing levels, analytical procedures).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/Residual-Solvents-Take-Advantage-of-the-New-Flexibility-in-Revised-USP-467-507766/AUGUST-2018-ES-TRAININGREGISTRY
The Pharmaceutical and Biotech industries are going through tremendous changes that have been increased by the recent global financial challenges. The FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping companies speed up development and improve their operations. 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/Sampling-How-Large-a-Sample-Do-I-Need-Determining-the-Right-Size-for-Accurate-Cost-Effective-Results-506454/AUGUST-2018-ES-TRAININGREGISTRY
Validation of computer systems is a regulatory requirement within the life sciences. "How much to validate" is one of the biggest challenges validation teams face. The struggle to balance time and available resources with compliance requirements often leads to insufficient testing and/or project overruns, which in turn can lead to significant regulatory and safety risks.
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/Effective-and-Practical-use-of-FMEA-For-Risk-Based-Approach-to-Computer-Systems-Validation-503169/AUGUST-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
Attend this introductory trade logistic session that provide valuable assistance to corporate import team and give company the tools to assess potential gaps.
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/Complying-with-Customs-laws-and-Responsibilities-under-the-Customs-Modernization-Act-507252/AUGUST-2018-ES-TRAININGREGISTRY
This webinar will notify how US FDA updated its PMA acceptance process and refuse to accept policy for initial reviews of (k) submissions.
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-FDA-s-Revised-Medical-Device-Product-Guidance-Refuse-to-Accept-Policy-for-510-k-s-and-Acceptance-and-Filing-Reviews-for-Premarket-Approval-Applications-PMAs-503623/JULY-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
Join this webinar to understand how Risk Management applies throughout the product life cycle and links to design control, production and process controls, and CAPA.
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/Risk-Management-Techniques-for-Medical-Devices-506211/JULY-2018-ES-TRAININGREGISTRY
Join this webinar Design of experiments "DOE" which is a systematic method to determine the relationship between factors affecting a process and the output of that process.
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/Effective-Design-of-Experiments-DOE-Strategies-503955/JULY-2018-ES-TRAININGREGISTRY
Attend this webinar you ll be able to identify the gaps in your current Aerospace Quality Management Systems AQMS and start planning your transition to the revised standard.
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/AS9100-2016-Rev-D-Transition-Key-Changes-You-Need-To-Know-Before-Sep-2018-509894/JULY-2018-ES-TRAININGREGISTRY
Know everything about 21 CFR Part 11 compliance and how to control electronic signatures and electronic records.
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/21-CFR-Part-11-Electronic-Record-and-Signature-Validation-508215/JULY-2018-ES-TRAININGREGISTRY
Attend this webinar to gain an understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
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-Validation-Overview-of-Why-and-How-507096/JULY-2018-ES-TRAININGREGISTRY
This webinar will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.
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/Reliability-Engineering-Fundamentals-for-Medical-Devices-503951/JULY-2018-ES-TRAININGREGISTRY
Attend this webinar series by expert speaker Dev Raheja, to get complete guidance on Fundamentals of Reliability and Safety Engineering for Medical Devices.
Price:$500.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link https://www.onlinecompliancepanel.com/webinar/Fundamentals-of-Reliability-and-Safety-Engineering-for-Medical-Devices-Webinar-Series-504744/JULY-2018-ES-TRAININGREGISTRY
Understand more about acceptance sampling plans for process validation and production lot acceptance by attending this audio conference.
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/Acceptance-Sampling-Plans-for-Process-Validation-and-Production-Lot-Monitoring-507734/JULY-2018-ES-TRAININGREGISTRY
This webinar provides insight into the kinds of clues an auditor might use in determining what areas to focus on.
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/Through-the-Eyes-of-an-Auditor-502991/JUNE-2018-ES-TRAININGREGISTRY
Join this training to examine the clinical data and literature review requirements found in MEDDEV 2.7.1 revision 4 to ensure CERs to meet notified body 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/Medical-Device-Compliance-with-MEDDEV-2-7-1-Rev-4-for-Clinical-Evaluation-CER-Reporting-508671/JUNE-2018-ES-TRAININGREGISTRY
This course is essential for medical device companies interested in submitting software enabled medical devices to the FDA for 510K approval.
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/Successful-510-k-Documentation-for-Software-or-Software-Containing-Medical-Devices-507429/MAY-2018-ES-TRAININGREGISTRY