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  • 1 Request Info

    Drug dissolution testing and establishing plasma drug levels in humans 2017

    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.
  • 2 Request Info

    Design Controls for Medical Devices - Regulations, Myths, Challenges, and Best Practices 2017

    Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet is still one of the most frequent areas for 483 and Warning Letter observations. This 2 days seminar will help you understand and develop design controls processes and tools that are a competitive strength for your company. Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And design problems can have disastrous results for your customer and for your company.
  • 3 Request Info

    The DHF, DMR, DHR, and Technical File - Design Dossier 2017

    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
  • 4 Request Info

    FDA's Latest Regulations for Computer Systems Used in the Tobacco 2017

    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.
  • 5 Request Info

    Webinar On Supplier Quality Management Utilizing Principles of Lean Documents and Lean Configuration

    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
  • 6 Request Info

    Statistical Process Control -verification, validation, risk management, Manufacturing, and QA/QC 2017

    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, from a risk management perspective
  • 7 Request Info

    Audit Like the FDA - How to develop and implement an efficient and effective audit program

    This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks.
  • 8 Request Info

    Seminar on Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)- Before 30 April 50% Discount for its All Seminars

    This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered: Total Product Life Cycle and Your Medical Device An Overview of U.S. FDA Medical Device Regulation Regulations for Design and Product Development Premarket Notification - 510(k) and Premarket Approval (PMA) Regulations for Production & Process Control Readiness for FDA Facility Inspection Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900772SEMINAR?trainingregistry_SEO
  • 9 Request Info

    An Advanced Course on Lean Documents, Lean Configuration and Document Control

    In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents. Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner.
  • 10 Request Info

    Webinar On Accounting and Reporting to Management on a Lean Basis

    This webcast will present an overview of lean processes with a focus on the accountant's role in the process of innovative reporting in a lean environment. As entities implement lean approaches in manufacturing, retail and service environments, accountants have realized that our reports are not as understandable or informative as they could be.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/ACCOUNTING-REPORTING-MANAGEMENT-505507/APRIL-2017-ES-TRAININGREGISTRY
  • 11 Request Info

    Webinar On Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

    Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls requires tracing backwards and forwards in order to link the requirements to their satisfaction, a problem faced by many companies is in having to maintain duplicate information across many controlled documents.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/DESIGN-INPUTS-OUTPUTS-TRACEABILITY-MATRIX-504902/MARCH-2017-ES-TRAININGREGISTRY
  • 12 Request Info

    LEAN SIX SIGMA YELLOW BELT CERT.

    Certification from Thayer School of Engineering at Dartmouth College; this workshop is for non-engineers that want to learn the basics of lean and six sigma process improvement and problem solving.
  • 13 Request Info

    "LEAN SIX SIGMA BLACK BELT CERT"

    Thayer School of Engineering at Dartmouth College Certification LSS Black Belt Training – (twenty 4-hour sessions) • Lean Six Sigma Black Belt workshop, LIVE (instructor-led) online sessions 8:30 am to 12:30 pm Eastern U.S. Time (2 session per week for 10 weeks) for a total of 10 days. • Certification from Thayer School of Engineering at Dartmouth upon successful completion of all requirements Note: All sessions are recorded for download to your computer in the event you miss a session or for review purposes
  • 14 Request Info

    Shutdown Turnaround Optimization Program Public Training Course

    Many industries spend the majority of their maintenance budget on shutdowns. Turnarounds represent a significant amount of downtime. The Shutdown Turnaround Optimization Program (S-TOP) delivers the minimum required shutdown scope and absolute minimum downtime. S-TOP accomplishes this by addressing mechanical, production, inspection, regulatory, and engineering project critical paths. The course objective is to improve outage management and execution through the systematic application the S-TOP best practices. Participants will learn how to implement and manage the 6 critical steps behind cost efficient and effective Shutdowns while maintaining a high level of safety.
  • 15 Request Info

    Preventive Maintenance Essential Care & Inspection Techniques Training Course

    IDCON's practical training course for maintenance technicians and operators teaches how to care for equipment and perform fundamental condition monitoring (inspection) techniques. Participants learn the basics behind effective lubrication, balancing, alignment, cleaning, electrical and installation practices. They will learn about common components such as motors, bearings, gearboxes and much more.
  • 16 Request Info

    Develop and Manage Preventive Maintenance Training Course

    IDCON's training gives you the knowledge to develop and implement a Preventive Maintenance System in a cost effective manner. Based on a simple step-by-step process that includes concepts such as criticality, failure modes, preventive failures, early failure detection methods and writing effective instructions for maintenance and operations.
  • 17 Request Info

    Webinar On Lean A3 Problem Solving

    A3 Problem Solving is a hands-on Lean tool that goes beyond problem solving to include clear communication, collaboration and coaching others to strive for excellence. This is a proven approach to finding effective, real solutions while also building your lean culture. This webinar is for any organization who wishes to understand A3 thinking or develop the ability to think critically, communicate well and enable collaborative approaches to problem solving and improvement.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://www.onlinecompliancepanel.com/webinar/LEAN-A3-PROBLEM-SLOVING-502057/FEBRUARY-2017-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar On Why and How to use Design of Experiments

    Design of Experiments (DOE) is a key tool for quality management and continual improvement, as well as part of the Six Sigma body of knowledge. It allows the scientific determination, beyond a quantifiable reasonable doubt, of whether there is a difference between two or more treatments (such as a control or experiment) or treatment combinations. This in turn allows us to determine whether a proposed improvement worked and also to pinpoint the source of poor quality when a cause and effect diagram suggests multiple sources.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/DESIGN-EXPERIMENTS-501996/JANUARY-2017-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar On Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

    The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/AUDITING-QUALIFYING-SUPPLIER-VENDOR-501737/DECEMBER-2016-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar On Drive Continuous Improvement with Shingo Maps and ISO 9001:2015

    Shingo process maps were developed originally to support kaizen events and other improvement events. They can, however, support managed continual improvement along with ISO 9001:2015's requirement (7.5) for documented information; a common role of the traditional process flowchart.Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link http://onlinecompliancepanel.com/webinar/SHINGO-MAPS-ISO-9001-2015-501917/DECEMBER-2016-ES-TRAININGREGISTRY