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Courses

  • 421 Request Info

    The Electronic Common Technical Document (eCTD): Strategies & Tools to Build a Successful Submission

    The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is highly recommended for marketing applications in the United States, and is mandatory in other regions, including Canada, Japan, and Europe. The eCTD format has become mandatory in key markets for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. In the US, the eCTD format has become a requirement for all New Drug Applications, Biologics License Applications and Abbreviated New Drug Applications following the 2012 reauthorization/update of the Prescription Drug User Fee Act (PDUFA). Further, the Generic Drug User Fee Act and Medical Device User Fee Act also impose mandatory electronic submissions to FDA. This course, while focusing on the US requirements, also provides . . .
  • 422 Request Info

    Introduction to Medical Combination Products

    This course covers current FDA regulatory compliance with respect to developing and marketing Combination Products. A focus is placed on relevant aspects of FDA regulations as well as the practical aspects of getting the Combination Product to market. Several example products will be highlighted to provide practical, hands-on instruction. The first part of the course provides general context for the overall topics surrounding combination products. Later, a more in-depth discussion on implementation within a complete combination product development environment is presented. FDA's regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course. This course will be most valuable to medical device/product professionals who need a firm understanding of how to gain FDA approval for combination products. The course is geared toward personnel that are newer to the industry or need to gain perspective of how to develop a successful . . .
  • 423 Request Info

    Introduction to Medical Device Submissions - 510ks, PMAs, and Exemptions

    This course covers current FDA regulatory compliance with respect to developing and marketing medical devices. A focus will be placed on relevant aspects of FDA regulations and the practical aspects of bringing a medical product to market. The course will initially cover the general context for medical device regulations. Later, a more in-depth discussion will begin to look at each of the submission categories in detail. FDA's regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course. Who Should Attend This 510(k) and PMA medical device submissions training course will be most valuable to medical device/product professionals who need an understanding of how to get medical devices into the US market while respecting FDA regulations. The course is geared toward professionals that are newer to the industry or who need to gain an understanding of submissions for the first time. Engineers, managers, supervisors, scientists . .
  • 424 Request Info

    Introduction to Effective Medical Writing

    Medical writing is both a science and an art. The art of medical writing is to comprehend and present scientific information clearly to suit the specific target audience's level of understanding including patients, the general public, physicians and/or regulatory agencies. Often it is not poor science that kills a scientific paper; rather, it is the lack of clarity and continuity. Poor writing can be very costly to companies and frequently slows the review process of regulatory submissions. In this 2-day course, you will learn about the different types of medical writing and how to write effectively. We will examine various types of writing including abstracts, regulatory documents, and patient education materials. We will also consider ethical issues that face medical writers. You will gain insight into the design of effective documents and what goes into putting together a compelling manuscript. You will also learn how to keep your writing free of medical jargon and common . . .
  • 425 Request Info

    Design Control for Medical Device Professionals

    This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines. Among the topics to be discussed are: context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion. Who Should Attend This course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers needing an understanding of Design Control per the FDA's CFR 820.30. The course also . . .
  • 426 Request Info

    Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries

    Course notes and interactive exercises address how to write effective correspondence and reports in support of the company's activities. You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable documents, and how to revise and refine your own and others' writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues. Who Should Attend Scientists, engineers, and technicians in research and development will find this course valuable, as will quality assurance (QA), information technology (IT), manufacturing, and other operations professionals. This course is also useful for administrative staff that must prepare documentation in support of R&D and operations activities. Additionally, the course is helpful for anyone who wants an in-depth and comprehensive overview of the structure of . . .
  • 427 Request Info

    Integration of Risk Management Principles and Activities into the Quality System

    The market’s Tolerance for Failure of Drugs, Devices and IVDs has reduced significantly since the 80s. This reduced tolerance is a reflection of a general loss of confidence in the medical industry. Adoption and certification of Quality Management Systems (QMS) has provided some recovery of that lost confidence but not enough – more is needed New requirements combined with concepts and applications of Risk Management as a practical set of principles, have emerged and when integrated with Quality Management Systems re-build confidence for the three major stakeholder groups: Regulators, Industry and most importantly the Medical Community - including users & patients. This course will cover Risk Management principals associated standards and practices together with how to develop, apply and implement strategies that reduce risks in the areas of drugs, devices and IVDs while working within established Quality Management Systems. Topics covered include: •Current US and international . .
  • 428 Request Info

    European Union Regulatory Issues – New Product Development

    This two-day course is designed to provide individuals with a detailed understanding of the important regulatory guidelines involved in the development of a new product plan within the EU. The program will also cover effective strategies for correctly applying the current regulations to ensure that rejections are avoided. The course will provide the attendee with a thorough knowledge of the following topics: •How to develop a regulatory strategy •How to deal with pricing and reimbursement issues in your development •How to validate your regulatory strategy (scientific advice) and how to choose between centralized and national scientific advice •When does your product qualify as an orphan medicinal product and what are the advantages if it does? •How to deal with pediatric development plans •What has to be considered for Advanced Therapy Medicinal Product and oncology medicinal products
  • 429 Request Info

    Best Practices for Cleaning Validation Program

    This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with process validation principles to facilitate reasonable and informed decision making and activity planning. Regulatory requirements and the latest industry practices will be included in the discussion to identify questionable practices that may be misdirected as well as the better practices that support and align with current process validation principles. The program will describe a risk-based approach for establishing an effective cleaning validation program, including the development of policies, master plans and the appropriate content for each study to be performed incorporating critical quality attributes and critical process parameters and process control. In addition, validation maintenance and life cycle aspects will be reviewed. Cleaning validation examples will be included from different sterile and non-sterile product types, and different types of dosage forms . . .
  • 430 Request Info

    Effective Document Management for the Pharmaceutical, Biotech and Medical Device Industries

    Course Description - Course runs 9:00 to 5:00 both days If you didn't write it down, it didn't happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don't tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls. This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant. Who Should Attend Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing . . .
  • 431 Request Info

    Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach

    Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the company's responsibility to ensure their suppliers/vendors meet all regulatory specifications for the supplied materials, components, equipment and/or services. For many years, industry has implemented procedures for selection, approval and qualification of suppliers and vendors. However, in many cases these protocols were not being implemented effectively or formally documented. Making these programs part of a risk-based quality system approach that the FDA and other regulatory agencies have come to expect from industry is critical. The course includes a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact . . .
  • 432 Request Info

    GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

    This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites. Additionally, attendees will learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct, as well as, dealing with its consequences, while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies. Additionally, the course will cover methods to detect misconduct and deal with fraud in clinical trials by: •Defining the basic requirements of Good Clinical Practices . . .
  • 433 Request Info

    Process Validation for Medical Devices

    The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with the principals of process validation. Internationally, regulators believe through careful design and validation of the process and appropriate process controls, a manufacturer can establish a "high degree of assurance" that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing. More recently, with the introduction of risk management to medical devices, it is important to correctly apply the principles of risk management when implementing and maintaining process validation activities. Newer products and processes pose additional challenges to organizations. New processes are more complex thereby making process validation more difficult. Using the tools developed in this course, participants will be able to . . .
  • 434 Request Info

    Medical Devices - Developing Effective Post Market Surveillance and Complaint Handling Systems

    As users and regulatory agencies are becoming less ‘tolerant' of medical device failure, regulatory agencies are placing greater emphasis on post market surveillance as a way to improve risk management and protect public health. This course will review the regulatory expectations for post market surveillance and outline how to apply the requirements to medical devices. Topics include: complaint handling & vigilance systems, Medical Device Reports (MDR), implementation challenges, medical device tracking, impact of post approval studies, compliance requirements & meeting them, and complaint systems inspections. Throughout the course, examples and case studies will help participants apply the concepts being covered. Who Should Attend This course will be of great value to medical device professionals involved in post market surveillance/complaint handling. It is primarily designed to benefit the following disciplines and personnel: •Post Market Surveillance •Complaint Assessment . . .
  • 435 Request Info

    Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications

    The European Union (EU) provides an attractive marketplace for medical device distribution. Development of requirements harmonized across the 27 member states should make it a straightforward process to get products approved in each country - but is it? This course works through the requirements for medical devices, the steps to obtain entry into the marketplace (including setting up a number of on-going procedures and relationships), and shares some lessons learned from the Course Director, who has over 20 years of experience with CE marking medical devices for distribution in the EU. The course will introduce the Medical Device Directives (AIMD, MDD & IVDMDD), the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity, the significance of Notified Bodies, Competent Authorities, and Authorized Representatives. Additionally, the significance of the QMS, ISO 13485 and ISO 14971, and reference to ISO 14000 will be explained as necessary . . .
  • 436 Request Info

    Introduction to Statistical Analysis of Laboratory Data

    Basic Methods (Day One). This section of the course will detail the basic and intermediate statistical concepts that are essential for professionals in the field. The first day emphasizes the principles of descriptive and inferential statistical applications and focuses on actual study examples, problem solving and interpretation of results. Throughout the course the participants are encouraged to ask questions and discuss examples relevant to their own work. Advanced Topics (Day Two). This section of the course will go beyond the basics and cover more complex issues in laboratory investigations with examples.
  • 437 Request Info

    Adverse Drug Events - Reporting & Regulatory Requirements

    This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues. Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail. Participants will be provided with templates for reporting requirements in each region covered. Multiple exercises are included to reinforce the lecture material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs.
  • 438 Request Info

    Product Quality Reviews

    Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. If used effectively, these reviews can be a powerful Quality Assurance tool. The Product Review Process includes: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action, Change Management and Management Review which are enablers identified in ICH Q10, The Pharmaceutical Quality System. It also includes the ICH Q10 enablers of Knowledge Management and Quality Risk Management. Contemporary guidance suggesting that the Annual Product Review can support the concept of Continued Process Verification and Quality Metrics. The purpose of the course is to educate the participant in the regulatory requirements for the Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool.