Quality, ISO, Six Sigma Training Courses

Per ICH Q10 Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. However integrating the principles of QRM into our quality processes is complex especially in a pharmaceutical organization.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/PHARMACEUTICAL-QUALITY-RISK-MANAGEMENT-506610/JULY-2017-ES-TRAININGREGISTRY

"Foreign material" is extraneous matter found in food that may render the food unfit for human consumption. Strictly speaking, foreign material is not biological, but metal, paper, paint, glass or other materials. Legally, the term also refers to all contamination of a non-microbial source, including human hair, parts of insects, cleaning fluids and even particles of the wrong food, such as meat in a vegetarian 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/FOREIGN-MATERIAL-CONTAMINATION-PREVENTION-PROGRAM-502598/JULY-2017-ES-TRAININGREGISTRY

This course provides a comprehensive presentation of the principles of measurement uncertainty analysis for direct and multivariate measurements and measurement systems. Knowledge of the uncertainty of measurement of testing and calibration results is fundamentally important for laboratories, their clients and all institutions using these results for comparative purposes. Uncertainty of measurement is a very important metric of the quality of a result or a testing method.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/UNCERTAINTY-CALIBRATION-TESTING-LABORATORIES-506003/JULY-2017-ES-TRAININGREGISTRY

For medical device manufacturers, human factors engineering has gradually become part of the standard expectations for products on an FDA approval pathway. Though it is possible to execute successful studies that only meet the FDA's minimum standards for human factors, this strategy does not necessarily result in products that have been optimized for safety and usability.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-DEVELOPMENT-LIFECYCLE-505949/JULY-2017-ES-TRAININGREGISTRY

This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization's performance specifically related to equipment, processes and documentation.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-QUALIFYING-SUPPLIERS-VENDORS-504232/JULY-2017-ES-TRAININGREGISTRY

This webinar explores the components of third party service provider risk. Developing a common understanding and definition of third party service provider risks, the participant will form a comprehensive base upon which meaningful review and interaction with senior management can occur. The session introduces a holistic way of looking at risks associated with third party service providers so that Boards of Directors, Senior Managers and other organizational leaders will develop and demonstrate thoughtful process behind this meaningful and valid way of competing in today's business world.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/2017-THIRD-PARTY-RISK-MANAGEMENT-508287/JULY-2017-ES-TRAININGREGISTRY

Changes in technologies and supply-chain arrangements have coincided with the expansion of regulations and standards to the entire supply chain. Unfortunately, many suppliers have not kept up or find themselves in a strange new world. It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations and requirements.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/QUALITY-MANAGEMENT-LEAN-DOCUMENTS-CONFIGURATION-504115/JULY-2017-ES-TRAININGREGISTRY

The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision in over a decade to the ISO 13485 Quality Management Systems standard, and the changes to the EU's Medical Device Regulation that was just approved in April 2017. All of these events have far-reaching effects on Quality Management Systems so it is critical to understand what has changed within ISO 13485:2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.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/workshop/QUALITY-MANAGEMENT-ISO13485-2016-504371/JULY-2017-ES-TRAININGREGISTRY

This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled for impurities. Pharma water systems must be designed, validated and monitored to ensure that the water produced meets specifications around the clock.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/PHARMACEUTICAL-WATER-SYSTEMS-509631/JULY-2017-ES-TRAININGREGISTRY

Validation of test methods is a critical requirement for the drug development process. Testing of drug substance and drug product for quality requires validated methods. In addition, testing samples for PK/PD studies requires methods that are consistent, robust, rugged, sensitive, and specific in a variety of matrices. Collecting sufficient data prior to validation that can reliably support acceptance require is a frequent issue.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/DRUG-DEVELOPMENT-PROCESS-509856/JULY-2017-ES-TRAININGREGISTRY

Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases.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/EXCEL-SPREADSHEETS-502490/JULY-2017-ES-TRAININGREGISTRY

This webinar will cover the basics on how to maintain a good Design History File (DHF) that will help a manufacturer in a regulatory compliance audit. The webinar will cover the structure of a DHF and steps to ensure that the DHF is completed as the design and development process progresses. The DHF needs to be maintained as design changes are performed. Information in the DHF can help facilitate design decisions, which often can affect the safety of the device. The DHF provides the knowledge base needed for the manufacturer to maintain the device. It also provides the secrets to a successful Design Control 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/GOOD-DESIGN-HISTORY-FILE-AUDIT-506688/JULY-2017-ES-TRAININGREGISTRY

Measurement systems analysis (MSA), or gage reproducibility and repeatability (R&R), quantifies measurement variation from inspectors (reproducibility) and the gage itself (repeatability). This returns a measurement of the gage's precision, or ability to get the same result consistently from the same part. Precision is the counterpart to accuracy, or the gage's ability to get, on average, the correct measurement from a part. Gages must be precise as well as accurate to perform their jobs. While ISO 9001:2008 required only accuracy (as ensured by calibration), the automotive ISO/TS 16949 standard requires MSA as well.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/SYSTEM-ANALYSIS-508858/JULY-2017-ES-TRAININGREGISTRY

This webinar will present a unique perspective on risks associated with extractables, leachables & elemental impurities (ELEI) in cGMP manufacturing of pharmaceutical, biologic and medical device products. The webinar will start with a definitional review of the topic and then present the current FDA perspective on impurities of these types in product. After that introduction, the instructor will present quality and compliance considerations related to ELEI.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/EXTRACTABLES-LEACHABLES-cGMP-MANUFACTURING-507103/JULY-2017-ES-TRAININGREGISTRY

Food Inspections, Recalls and Criminal liability address the spectrum of proactive to reactive compliance elements within the food industry. From pre to post harvest, from food manufacturing to retail/restaurant, compliance activity is both embraced and, in some cases, avoided. This webinar will cover foundational statutes of state and federal inspection activity (USDA and FDA) of food, as well as recall authority. Current trends in recalls will be explored. We will also analyze recent changes to the prosecutorial landscape of criminal liability in regards to food.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/FOOD-INSPECTIONS-RECALLS-CRIMINAL-LIABILITY-505438/JULY-2017-ES-TRAININGREGISTRY

TRENDS FOR THE ENVIRONMENT/EPA-- Over the years EPA has continued to create regulations; now approaching 90% of the almost 30,000 pages of federal regulatory requirements. This is not expected to continue. How the new president and his administration will affect regulations in place and in the pipeline is still unclear at this time.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/EHS-RULES-REGULATORY-CHALLENGES-502195/JUNE-2017-ES-TRAININGREGISTRY

During this webinar, strategies for remote monitoring will be discussed, including the review of data for trends, how to make the most of writing queries, and what "red flags" to look for that may indicate issues on site. Across the industry, companies are striving to find ways to improve operational efficiencies. Currently, over 80% of site-based documentation today is still fully paper based, with both cost and risk consequences for the entire clinical trial 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/REINVENTING-REMOTE-MONITORING-CLINICAL-TRIAL-503276/JUNE-2017-ES-TRAININGREGISTRY

While it is vital that a food company must have knowledgeable managers on staff to keep up with food safety and quality, it is equally vital that the knowledge be shared with those front line employees. This can be a great weakness within companies as the task seems overwhelming and outside everyone's job description. Employees are your last line of defense in many cases for preventing food quality or safety deviations. Training them in a manner that is effective, useful and empowering is a priceless investment in the success of the company.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/FOOD-SAFETY-QUALITY-TRAINING-PROGRAM-502906/JUNE-2017-ES-TRAININGREGISTRY

This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise.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/CCO-CRO-FUNCTION-506414/JUNE-2017-ES-TRAININGREGISTRY

In many countries around the globe, certain medicines with a long history of use are allowed to be sold over the counter (OTC) at certain doses without a prescription. So the safety and efficacy are well known from a public health/patient safety perspective, a contaminated OTC medicine could potentially impact a larger user population than a prescription medicine.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/PRESCRIPTION-GMPs-FDA-FORM-483-506801/JUNE-2017-ES-TRAININGREGISTRY