Quality, ISO, Six Sigma Training Courses

Recently the FDA released their draft guidance for industry entitled "Request for Quality Metrics". Much discussion of quality metrics has ensued regarding this guidance and its elements. This presentation provides an integrated view of the aspects of Quality Metrics including the required supporting quality culture..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/METRICS-PROGRAM-503090/AUGUST-2017-ES-TRAININGREGISTRY

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. We’ll discuss the top mistakes that companies make and how you can avoid them..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/TOP-PROCESS-VALIDATION-MISTAKES-509627/AUGUST-2017-ES-TRAININGREGISTRY

There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is then collected and plotted on a control chart. Using Nelson's rules of statistical use of control charts, the individual uncertainties are monitored. This allows for early observation and intervention before a non-compliance occurs..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-DESIGN-ANALYTICAL-METHOD-502373/AUGUST-2017-ES-TRAININGREGISTRY

Laboratories that perform cell-based methods must meet stringent GMP guidelines for analytical procedures. In addition, standard operating procedures that specifically address working with cells should be in place to maintain control of a live assay system. GMP inspections should cover additional topics in cell-based laboratories to confirm procedures are sound from a regulatory perspective.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-AUDITING-CELL-BASED-METHODS-506592/AUGUST-2017-ES-TRAININGREGISTRY

Nobody at your facility has been hurt in more than a year. Weekly inspection forms are returned with no non-compliances. Are the facility's safety plans really working that well or is it just luck? Conducting a safety audit is one of the proven ways to answer that question.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/IMPLEMENTING-EFFECTIVE-SAFETY-AUDITS-507553/AUGUST-2017-ES-TRAININGREGISTRY

Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.

Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail.

Japan's classification system differs from that of the United States or European Union Medical devices are classified to Class I, II, III, or IV depending on their risk level Medical devices must also comply with Japanese Industrial Standards and these standards define industry-wide safety and performance requirements Strict new package insert requirements Change to MAH Licensing rules A new MAH License category for In Vitro Diagnostic (IVD) devices A new registration system for manufacturers A new QMS conformity assessment system New formats for pre-market certification and pre-market approval applications Expanded scope of third party certifications Rules for software as a medical device Rules for transferring pre-market certifications And Much More...

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable. One such example is the Medical Device Single Audit Program [MDSAP], where Authorized Organizations would be allowed to carry out a single GMP audit on medical device manufacturing facilities and have it stand to support registrations across the current participating member countries: U.S. Canada, Brazil, Australia and Japan.

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements

Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.

We will consider the following: The Design Control requirements of the CGMPs, 21 CFR 820.30 The Design History File - documenting Product Design Control and its nine elements The Device Master Record and the Device History Record The EU's Medical Device Directive The "Essential Requirements"; and their documentation The remaining elements of a Technical File / Design Dossier Trends Two attendee projects

The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA's authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (water pipe) tobacco, pipe tobacco and nicotine gels, among others. The rule went into effect on August 8, 2016.

This course will cover the current regulations and importance of preparing and handling sterile and hazardous pharmaceuticals. It will also review the proposed regulation concerning all aspects of handling hazardous drugs and is appropriate for medical, nursing and pharmacy workers. Understanding these regulations will allow users to future-proof their facility and employ best work practices when performing both non-sterile and sterile HD handling.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/USP-HAZARDOUS-DRUGS-HANDLING-HEALTHCARE-505360/AUGUST-2017-ES-TRAININGREGISTRY

This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi requirements management KPA, helps companies meet FDA's design control 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/COMPLIANCE-FDAs-DESIGN-CONTROL-504040/AUGUST-2017-ES-TRAININGREGISTRY

Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP guideline, recently released EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.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-CLINICAL-TRIALS-506955/AUGUST-2017-ES-TRAININGREGISTRY

Open Payments is a federal program under the Centers for Medicare and Medicaid Services (“CMS”) that collects certain information relating to payments and other items of value provided to physicians from drug and device companies. Examples include: speaking fees, gifts, meals, and covering the cost of travel expenses to name a few. The Open Payments program also includes information on ownership interests a physician may have in a drug or device 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/COMPLIANCE-CMS-PHYSICIAN-OPEN-PAYMENTS-RULE-503037/AUGUST-2017-ES-TRAININGREGISTRY

With mobile platforms more user friendly, and with computers, tablets and smart phones becoming more powerful, we see an increase in the offering of apps. Some of these apps are specifically targeted to assist individuals in the management of their health and wellness, while other apps are targeted to healthcare providers as tools to assist in the delivery of care.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/MOBILE-MEDICAL-APPS-CYBERSECURITY-509085/AUGUST-2017-ES-TRAININGREGISTRY

Poor quality is only one of the Toyota Production System's Seven Wastes, and it is the only waste that makes its presence known. ISO 9001 has focused historically on avoidance of poor quality, although ISO 9001:2015 is far more explicit in its requirement for continual improvement of all aspects of organizational performance. The idea of auditing for performance and results rather than compliance with a quality management standard has meanwhile gained recent visibility, although this webinar will show that "rather" is not an 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/ISO-9004-ISO-WORLD-CLASS-PERFORMANCE-506043/AUGUST-2017-ES-TRAININGREGISTRY

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.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-MEDICAL-DEVICE-BIOLOGICS-INDUSTRY-505657/AUGUST-2017-ES-TRAININGREGISTRY