Manufacturing Skills - Management

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Courses

  • 1 Request Info

    21 CFR Part 11 Guidance for Electronic Records - 2018

    Overview: This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. Why should you Attend: This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.
  • 2 Request Info

    21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

    All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records. Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods and complex filing systems for purposes of retrieval and control. These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry.
  • 3 Request Info

    AB RSLogix PLC Training

    Business Industrial Network provides on-site Allen- Bradley Programmable Logic Controller (PLC) troubleshooting training as well as seminars. (1.6 CEU) Now also free RSLogix 5000 training software to every attendee. No one else comes close to matching the value we offer.
  • 4 Request Info

    Applied Statistics, with Emphasis on Verification, Validation, Sample Size, and Risk Management, in R&D, Manufacturing, and QA/QC

    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
  • 5 Request Info

    Auditing and Inspecting Preclinical Research for GLP Compliance

    The Good Laboratory Practice (GLP) guidelines have progressed through various transitional phases to become guidelines in some countries and regulatory/statutory instruments in others. The objective of the GLPs is to ensure that a standard approach is undertaken, covering traceability and accountability of medical research and drug development process. This webinar discusses various aspects of auditing and inspecting preclinical research compliance with GLP. 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-and-Inspecting-Preclinical-Research-for-GLP-Compliance-503774/DECEMBER-2017-ES-TRAININGREGISTRY
  • 6 Request Info

    Benefits of your SPC Program for Maximizing the 10 Keys

    Overview: Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified. However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Why should you Attend: The webinar will provide a high level overview of Statistical Process Control. Ten important keys to maximize the benefits of SPC in any company are described in detail. The ten keys range from technical considerations to management practices. An understanding of these important factors will allow SPC to be implemented effectively so that the expected benefits may be realized.
  • 7 Request Info

    Branding Your Culture

    Richard Mills provides proven methods to focus on the most important part of your company - your culture. Companies have products, services, intellectual property, financial assets, people and market recognition. The one thing that ties all of these resources together is culture. An organization's culture is the life force that defines its goals, fuels its development and measures its successes. What the marketplace perceives of an organization is usually the products it produces or services that it provides. The outward image of the company is its brand. This is not bad but it is a shortcoming of what is completely "behind the veil". Currently, a vast majority of brand loyalty the link to a company and its culture and not just the product or service. It is the ability to leverage this loyalty and culture that will provide market strength and grow when it would otherwise not occur.
  • 8 Request Info

    Cleaning Validations Using Extraction Techniques

    Cleaning validations are an essential step in the medical device development process. One of the most common methods is using extraction techniques to validate the cleanliness of a device. This webinar will provide valuable guidance on how to achieve a thorough validation of a cleaning process. These cleaning processes may include initial cleaning validations, in process cleaning validations, or reprocess cleaning validations.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/Cleaning-Validations-Using-Extraction-Techniques-507793/DECEMBER-2017-ES-TRAININGREGISTRY
  • 9 Request Info

    Communications for Medical Facilities and First Responders

    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.
  • 10 Request Info

    Control for Medical Devices and Combination Products

    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.
  • 11 Request Info

    Corrective and Preventive Action (CAPA)

    Overview: Medical Device managers, engineers, QA personnel, as well as lean program leaders. Do you find yourself constantly struggling to create, manage, and maintain all of the information found in Corrective and Preventive Actions (CAPA)which is often redundant, repetitive, and chained together in a cumbersome way? Do you find that your design and manufacturing resources are spending way too much time on documenting the CAPA process and not enough time on actually correcting and preventing systemic issues? This webinar presents a fresh new approach based upon solid principles and proven practices - as well as an alternative that avoids many of the pitfalls of traditional ways of preparing these documents.
  • 12 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.
  • 13 Request Info

    Ensuring Medical Devices are safe and [Effective] for Intended Uses

    Overview: Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them. You'll learn techniques that can help you identify hazards and potential harms. You'll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products.
  • 14 Request Info

    Expectations for Products Used in Early Phase

    FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.
  • 15 Request Info

    Guidance on Inactive Ingredients- FDA Update

    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
  • 16 Request Info

    How to apply statistics to manage risks and validate processes in 2018

    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
  • 17 Request Info

    How to Identify and Eliminate Multiple Root Causes

    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.
  • 18 Request Info

    ICH Q11- API Manufacturing - 2017

    Overview: This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
  • 19 Request Info

    Incentivizing True Growth - Targeting the Right Behavior

    Richard Mills delivers in-depth insights on incentivizing individuals, teams and entire organizations with plans that reward positive results and acknowledges mutual success. Territorial concerns and isolationist actions can be avoided with the proper balance of targets, metrics and milestones. When goals are set for a single sector of the organization and they do not match the goals of another sector, then offsets must be applied to compensate for the actual control that each group has to achieve their respective goals.
  • 20 Request Info

    Is it Method Verification or Validation

    Overview: The Webinar will discuss the distinction between and requirements for method validation and method verification, to comply with ISO/IEC Standard 17025:2005 for laboratory accreditation in food/water microbiology. Quantitative and Qualitative methods have different performance measurement requirements and require different statistical analyses. Why should you Attend: Without a clear understanding of the different analytical approaches for verification and validation, laboratories often end up doing more unnecessary, costly work, with little benefit. Very often the inappropriate analytical strategy used is unacceptable to meet the requirements for accreditation and the effort needs to be repeated. Learn to do it right the 1st time.