Manufacturing Skills

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

Join this webinar to understand relevant inspection steps in relation to Root Cause, how to use RCA to better effect, what RCA tools really, 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/Problem-Solving-Root-Cause-Analysis-in-Pharma-Manufacturing-503456/JULY-2018-ES-TRAININGREGISTRY

This webinar will explain the various US and international regulatory requirements for clean room classifications and the environmental monitoring of clean room environments. 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-Environmental-Monitoring-for-Pharmaceutical-Clean-Rooms-508386/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

By attending this webinar you will learn how to identify and eliminate multiple root causes impacting your organization's bottom line, evidence contributing to root cause conditions and methods to correct root causes, also explains suggestions for keeping processes safe from competitors.

Auditing Foreign Vendors for FDA Compliance 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/Ensure-Your-Foreign-Vendor-is-FDA-Compliant-Conducting-Vendor-Audits-Monitoring-and-Use-Checklists-503813/JUNE-2018-ES-TRAININGREGISTRY

The webinar will provide systematic approach in understanding FDA's thinking as well as practical approach to why and how to develop device without doing unnecessary work while focusing on what's really needed. As we satisfy FDA's needs, results will likely be positive.

During natural disasters new media claim there is no communications with effected area.Hurricanes destroy a large area including power and communications,however, when storms pass Amateur Radio operators are first to operate using backup power and provide communications to hospitals, FEMA and SHARES.

All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Attend this webinar to learn about good design principles, with the control measures necessary to maintain microbiological control in pharmaceutical facility water systems. 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/Good-Design-Practices-For-Pharmaceutical-Water-Systems-509151/JUNE-2018-ES-TRAININGREGISTRY

Join this session to discuss the implementation of risk management and knowledge management pillars for the controlled substances systems at the pharmaceutical facilities. 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/Processing-of-cGMP-Controlled-Raw-Materials-504506/JUNE-2018-ES-TRAININGREGISTRY

Learn how to create and maintain good documentation that meets FDA computer system validation and compliance standard. 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/Good-Documentation-Practices-to-Support-FDA-Computer-System-Validation-and-Compliance-504252/JUNE-2018-ES-TRAININGREGISTRY

Attend this webinar to understand the FDA and USP Requirements for System Suitability Testing in the Pharmaceutical Laboratory. 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/System-Suitability-Testing-in-the-Pharmaceutical-Laboratory-Addressing-FDA-and-USP-Compliance-509647/JUNE-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

Training on allergen management will describe, with latest approaches for cleaning, validation, monitoring and preventative controls under FSMA. 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/Allergen-Cleaning-Validation-and-Preventative-Risk-Mitigation-506388/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

Attend this webinar to know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. 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/Bonified-CAPA-Investigations-503630/JUNE-2018-ES-TRAININGREGISTRY

During the hour presentation participants will learn new approaches to understand strategic risk 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/Recognizing-and-Managing-Strategic-Risks-506358/JUNE-2018-ES-TRAININGREGISTRY

This two-day workshop covers the essentials of production and process control. Beyond the fundamental elements, the workshop provides practical methods to help create a robust system for device production - one that can withstand a rigorous FDA Inspection or MDSAP Audit. Exercises provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning Letters, the Quality System Inspection Technique (QSIT), and the Medical Device Single Audit Program (MDSAP) provide an opportunity to apply the information.