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Courses

  • 81 Request Info

    Webinar on 2011 FDA Guideline on Process Validation

    Overview: The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. Why should you attend: This is a topic very near and dear to those who are involved with qualification and validation. Of all the topics regarding compliance this subject area has to be the most re-invented. Who Will Benefit: Compliance Personnel QA Personnel validation Personnel Speaker Profile: Louis Angelucci is a pharmaceutical professional and Certified Quality Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1WhE3Zn
  • 82 Request Info

    Webinar onFDA Regulation of Combination Products

    Overview: A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Areas Covered in the Session: Definition of combination product FDA Regulatory Pathways Primary Mode of Action User Fees Who Will Benefit: Regulatory professionals working in the field of combination products Speaker Profile: Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1LLEDvl
  • 83 Request Info

    St. Petersburg Conference on Equipment, Facility, and Process Qualification and Validation - A Simple Top to Bottom Sustainable Approach

    Overview: Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: • Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ), • Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer • For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software validation effort or through the equipment qualification program? Location: St. Petersburg, FL Date: December 3rd & 4th, 2015 Time: 9 AM to 6 PM Venue: Courtyard St. Petersburg Downtown Address: 300 4th St N, St Petersburg, FL 33701, United States Until November 15, Early Bird Price: $1,295.00 From November 16 to December 01, Regular Price: $1,495.00
  • 84 Request Info

    Hong Kong Conference on Validation and Part 11 Compliance of Computer Systems and Data

    This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to report. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures. The 2-day course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates.
  • 85 Request Info

    Sydney Conference on Validation and Part 11 Compliance of Computer Systems and Data Australia

    The 2-day course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.
  • 86 Request Info

    Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future at Las Vegas, NV

    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 Why should you attend? This seminar / workshop will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, their similarities, as well as the two different device classification schemes. Required and desirable contents will be discussed.
  • 87 Request Info

    Seminar on Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing at Boston, MA

    The 2-day seminar explains how to apply statistics to manage risk 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. • 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
  • 88 Request Info

    Product Information for Medicinal Products in the EU at Boston, MA

    Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices. It is also important that patients and caregivers, as appropriate, are made aware of the information contained in the Package Leaflet (PL) and should be encouraged to read it prior to and during their treatment.
  • 89 Request Info

    Seminar on Medical Device Complaint Handling at San Diego, CA

    Does your Complaint Management system provide value to your company? It does if your company handles complaints efficiently and effectively - taking them through the reporting, classification, investigation, corrective action, and design change phases. Your system is effective if it recognizes the requirements to report to regulatory agencies (such as FDA, the EU, and Health Canada) and ensures you make the reports on time. An integrated system addresses multiple elements: Designated individuals and their required skill sets Procedures to define the process and standardize work Records to maintain and their prescribed content Reports to file with regulatory agencies and their timeframe The workshop covers all of these elements and includes checklists to help you integrate them into your QMS. To help clarify the issues, the workshop includes FDA Warning Letters.
  • 90 Request Info

    Modern Approaches to Process Validation: Requirements for Process Design, Design of Facilities and the Qualification of Equipment and Utilities

    Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are: • Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ), • Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer • For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software validation effort or through the equipment qualification program? Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.
  • 91 Request Info

    Designing and Monitoring Approvable Medical Device (cardiovascular) Protocols

    Construction of an approvable clinical trial protocol requires, excellent scientific writing and organization skills. Also paramount is gathering necessary information to manage the statistical analysis and data management of the study. This usually starts with a literature review, establishing key efficacy and safety parameters and determining proper sample size. Sample size calculations are a very important aspect of clinical trials, as are the consent and data collection forms, therefore the statistics and data management departments must be included for their input into the protocol and timelines.
  • 92 Request Info

    Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)

    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
  • 93 Request Info

    Supplier Management for Medical Device Manufacturers

    Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections.
  • 94 Request Info

    Seminar on Supplier Management for Medical Device Manufacturers Berlin, Germany

    In this seminar you will review all the quality management system requirements of FDA and ISO 13485 and then learn how to set up and manage an audit system that complies with these requirements, yet is risk-based so that your company makes the most efficient use of auditing resources for both internal and supplier audits. The seminar will include interactive exercises to reinforce the fundamentals of conducting and documenting quality system audits. Auditing principles taught in this seminar will be based on ISO 19011:2011 Guidelines for auditing management systems.
  • 95 Request Info

    Webinar on Sample Size and Statistical Rationale for Medical Device Packaging Validations

    Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes. Areas Covered in the Session: Statistical Rationales-the importance and application of developing an appropriate sample size for testing Compliance and guidance for: Medical device sterile barrier systems Determining sample size for sterile barrier systems (packaging systems) A process for developing an appropriate and statistically valid test population
  • 96 Request Info

    Webinar on Validating Radiation Sterilization for Medical Products

    Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success. The following subjects will be covered in detail: Materials Guidances - AAMI TIR # 17, ASTM Sterilization validation and Bioburden Shelf Life Test Methods - Accelerated Aging design Product design.
  • 97 Request Info

    Webinar on Introduction to Risk Assessment

    Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.
  • 98 Request Info

    Webinar on Medical Device Product Development Process

    We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork. The process is a methodical approach that can be used with almost any product development process from concept to production.
  • 99 Request Info

    Webinar on Medical Devices - ISO 13485 – Do You Really Know What You Need To?

    A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines. What must a documentation system look and feel like to ensure compliance? These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp. Clean rooms 101, we can assist in what to do and what not to do. From the infrastructure, to the maintenance, PPE, etc. It is a holistic system that must be maintained at optimal standards at all times. How is the quality within the organization? Materials must be accounted for and properly maintained. Only the highest quality materials should be utilized to create a unique and durable product.
  • 100 Request Info

    Webinar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

    This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.