Medical Devices

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  • 421 Request Info

    Webinar on Hazard Analysis Following ISO 14971- Risk Management

    In this webinar we will explain in detail the process of conducting a hazard analysis and how to integrate hazard analysis into the design program. Join today. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link -
  • 422 Request Info

    Webinar on Simplified CAPA Process - 21 CFR Subpart J of FDA Regulations

    Learn 21 CFR subpart J of FDA regulations related to CAPA, how to integrate CAPA with other branches of QMS. Register today for this webinar. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link -
  • 423 Request Info

    Writing in the Regulated Environment When English Is Your Second Language

    Course Description - Course runs 9:00 to 5:00 both days This course presents a comprehensive overview of the structure of American English to give non-native writers of English the tools they need to produce clear, complete, and comprehensive documents. Participants will learn about English within the context of the type of writing the therapeutic products industry requires. The course covers the structure of the language and how to control the individual components, as well as the choices writers have in delivering messages. The course also addresses specific aspects of English that are problematic for individual participants. Attendees should come prepared with specific questions they want answered during the course.
  • 424 Request Info

    Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment

    This is a three-day course designed to provide individuals with an in depth understanding of the design, balancing, commissioning, operation and maintenance of HVAC systems in a regulated environment. The course consists of lectures and imbedded exercises. Participants will also be placed in several real life situations such as completing a compliance review of floor plans and air flow diagrams, room pressurization schemes, ductwork design, and air balance reports; conducting emergency egress analysis during a system failure; HVAC risk assessment; and change control analysis including the impact of modifications requested by the end user. The course is designed to provide the attendee with thorough knowledge of the following topics: •The governing regulatory agencies with direct impact on HVAC systems •FDA and EU classified space comparison •What constitutes Good Engineering Practice •The major components of an HVAC system •A high level overview of Psychrometrics
  • 425 Request Info

    Water Purification Systems for Regulated Industries - Design, Chemistry and Validation

    The course consists of interactive lectures, discussions, and imbedded exercises. Participants will also be placed in several real life situations where they complete a compliance review of a schematic process flow diagram, analyze failures using trend reports, critique a risk assessment, and perform a change control analysis including the impact of requested or proposed modifications. The course is designed to provide the attendee with a practical understanding of the following topics: •Basic water chemistry •Water quality selection criteria •EPA, EU, and WHO drinking water standards •The governing regulatory agencies with direct impact on water systems •Analytical water grades (1, 2, 3) and reagent water types (I, II, III, IV, with A, B & C subgroups) •Pharmacopeia water grades (Purified, Highly Purified, Water for Injection & Clean Steam) •Pretreatment component equipment - selection and operating principals •Final treatment options (reverse osmosis, vapor compression, single-effec
  • 426 Request Info

    Cleanroom Microbiology for the Non-Microbiologist

    This course provides comprehensive practical information on microbial contaminants and contamination control in modern cleanrooms. Extensive guidance is presented on the daily functions and monitoring necessary to maintain required cGMP microbial and particle cleanliness levels in cleanrooms. Topics to be discussed include: •Basics of microbial biology and physiology •Cleanroom design requirements •Sources of microbial contamination in cleanrooms •Non-viable airborne particle standards and monitoring •Airborne and surface microbial standards and monitoring •Origin and minimization of pyrogen contamination •Cleaning technologies and operations •Disinfection and sanitization materials and techniques •Rapid microbial monitoring methods •Training methods for proper contamination control Emphasis is placed on attendees sharing information on their practical cleanroom knowledge and experiences with the group. An extensive appendix providing tables, technical discussions, and . . .
  • 427 Request Info

    Understanding Sterilization Methods for Products and Devices

    The course provides a basic but comprehensive presentation of sterilization procedures as they are used in the pharmaceutical and medical device industries.After you complete this course you will understand how and why specific sterilization methods are used in particular applications, how the methods are validated, and the strengths and weaknesses of different methods. You will understand what equipment is used in sterilizations, sterilization cycle development, sampling of products for sterility, and sterility assurance.You will also be presented with the latest developments in the microbial monitoring techniques used in sterility estimations. An extensive appendix providing detailed discussions of some sterilization topics and scientific literature references is included with the course notes. The purpose of the appendix is to provide supplementary material for attendees who wish to go deeper into specific aspects of sterilization after the course.
  • 428 Request Info

    Clinical Trial Design for Medical Devices

    Clinical studies are an integral part of the approval process for medical devices. While some devices may be approved with little or no clinical data, for others, manufacturers need to demonstrate, with safety and effectiveness data in the target population, that the product is safe for human use. This course offers an overview of the regulatory process for medical device applications, including medical device clinical trial design and implementation. Throughout, examples and case studies will help participants apply the concepts being covered. 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.
  • 429 Request Info

    Project Management for Medical Device Product Development

    Efficient and effective project management of medical device product development projects can significantly impact the project scope, timelines and budget for the development of a product. Project managers must understand the development process and the key aspects of the stage gate phases and design control requirements in order to be able to plan and execute effectively. Successful completion of the product requirements gathering, product design, verification and validation are key project milestones and this course focuses on the best practices for managing these projects from developing the Charter to conducting Lessons Learned. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.
  • 430 Request Info

    Writing Effective Standard Operating Procedures and Other Process Documents

    This course presents a comprehensive overview of process writing that the binding regulations require. There's a tenet among regulatory bodies: "If you didn't write it down, it didn't happen," and while the regulations tell companies what they need to do and document, they don't tell them how. Determining how systems work and how processes occur and documenting them is up to companies to assess. This course presents process writing within the "big picture" of controlled documentation and gives industry standards for delivering information. Effectively prepared process documents keep companies on track and compliant. Participants will learn how to write documents that ensure consistency in operations. A workshop in process writing gives participants the opportunity to actually write about a process and then assess the results. The course also addresses problematic areas of the English language and affords participants the chance to voice their questions. Participants will learn . . .
  • 431 Request Info

    Clinical Document Management – A Trial-by-Trial Approach to Compliance

    This course explores the international challenges of trial records management: people, culture, and systems. With so many trials occurring in Brazil, Russia, India, China, South Korea and Turkey, as well as the US, Canada and Europe, the confluence of cultures presents unique challenges. This course offers suggestions for building a workable, sustainable system for clinical documents and data with practical templates, processes and solutions to common problems. This course also reviews the range of documentation that sponsors and sites need to control and generate for a successful outcome. It also addresses what to do with records once a trial is complete. Who Should Attend Conducting clinical trials and accruing accurate and viable data is the most expensive component of the drug development paradigm. Clinical teams are held accountable to ensure the most efficient and effective delivery of high quality data from each and every trial that they complete. Even in this day of . . .
  • 432 Request Info

    Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries

    A robust audit program is a key stone of an effective Quality System. The need for internal (self-inspection) quality auditing has been recognized, and is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. In addition it is starting to become the industry expected "norm" in the area of pre-market clinical development. Experience reveals that many internal company quality audits and many external supplier/contractor quality audit programs are ineffective. This course provides the rationale, strategies, techniques and tips, on how to plan and perform effective audits. The course explores the politics, psychology and all the technical aspects of auditing, including discussions of their logistics, tools, and frequency. The course evaluates the talents and personnel characteristics required of those who consistently perform thorough audits which yield optimal compliance . .
  • 433 Request Info

    Selecting & Managing CROs

    This course will provide the attendees with the specific methodology and management techniques to successfully outsource pharmaceutical programs that should then be more likely to be completed on time, within budget, and most importantly, with a high level of quality and performance. Participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient given the state of the industry. The following topics will be discussed: •Types of CROs •All or none - What should you outsource? •How the FDA views CROs •Sponsor responsibilities •Writing the RFP •Evaluating responses to the RFP •Pre-Qualification of vendors and vendor audits •Contract negotiations and partnering with CROs •Managing the CRO The processes in managing CROs, including study plans, in-field site visits, preparation for inspections, and monitoring evaluation programs will be discussed.
  • 434 Request Info

    Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

    This course provides a comprehensive description of the various regulatory and legal standards and their specific application to the advertising and promotion of drug and medical device products including detailed analysis of advertisements and promotion. These include regulations and policies of the FDA, FTC, DEA, PHS, Office of the Inspector General (OIG), state attorneys general and prosecutors, and professional guidelines of relevant organizations including ACCME, ACP, PhRMA and the AMA. The course will cover marketing and promotional issues specific to brand-name (prescription and OTC), generic, and compounding pharmacy contexts, including such areas which are "in flux" as Continuing Medical Education, Advertising of Compounding Products, Off-Label Promotion, Gifts to Physicians, and Direct-to-Consumer Advertising. Advertisements and case studies, including notable enforcement actions by the FDA and FTC will be discussed. Additionally, case law will be examined in detail . . .
  • 435 Request Info

    Comprehensive Overview of FDA Regulatory Compliance for Medical Devices™

    This course discusses the FDA's regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections. The course provides the attendees with the most important regulatory resource materials needed to understand agency policies and enforcement actions. Issues to be covered include: •Structure of the FDA and current FDA regulatory compliance practices - how to work with FDA investigators •The regulatory approval process – "what the FDA is looking for" in 510ks, PMAs and other pre-approval applications •The scope of FDA's compliance programs, policies and potential enforcement actions •Discussion of post-marketing notification and reporting programs •Strategies for development of an in-house compliance program for GMPs which . . .
  • 436 Request Info

    Validation of Computer Systems

    This course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized. Topics to be discussed include: •The regulatory expectations for computer validation •Relevant FDA warning letters •The tasks and deliverables expected for computer validation •Why validation processes vary so much •Strategies for practical, yet defensible computer validation •Sops required for system operation and maintenance •21 CFR part 11 and it's implications for common regulations •An active discussion of part 11 examples and audience questions •The implications of GAMP 5 on computer validation and how to transition from GAMP 4 •Auditing GXP computer systems and suppliers
  • 437 Request Info

    FDA Inspections - What Regulators Expect and How to Prepare

    This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities. Additional benefits of this class include discussion of: •FDA authority and process including 483s, Warning Letters, recalls, and other potential actions •The FDA inspection process and approach •Device Master Records requirements •The use of a mock audit and outside certifying audit •Required documentation, format, and archive •How to respond to inspection and audit results •Parallel process from the EMEA, TGA, PMDA, and other international regulatory agencies •A chance to actively learn form fellow participants and well as from an instructor who brings 30 years of practical regulatory experience to a lively combination of lecture, discussion, and exercises
  • 438 Request Info

    Biostatistics for Non-Statisticians

    The first two days of this course will introduce and detail the basic and intermediate statistical concepts that are essential for professionals in a biological, public health or medical environment. The first day will emphasize the principles of descriptive and inferential statistical applications while the second day will focus on actual study examples, problem solving and interpretation of clinical (efficacy and adverse events) results. Throughout the course, participants are encouraged to ask questions and discuss examples relevant to their own work. The third day of course will cover more complex issues in research investigations and clinical trials. Topics will include: •Association studies including correlation and regression analysis with clinical applications to multiple intervention strategies •Examination of Phase II and III clinical trials analysis. Comparative studies will contrast superiority, equivalence and non -inferiority approaches to design and analysis . . .
  • 439 Request Info

    Advanced Topics in Biostatistics for Non-Statisticians

    This pharmaceutical and medical device training course begins with a brief introductory discussion that will introduce and outline the types of clinical investigations conducted. This includes Phase II (non- randomized and randomized) and Phase III randomized clinical trials. It will emphasize the principles of clinical investigations and the issues to be addressed in the remainder of the course. Also the concept of the p-value and power will be reviewed. Statistical topics will include, but are not limited to: •Multiple primary and secondary endpoints in clinical trials and the techniques for addressing the multiple testing procedures that have been proposed •Missing data in clinical trials, the types of missing data that can arise and the issues involved for handling and interpreting the results from lack of data •Adaptive designs in clinical studies when an interim analysis indicates a possible midway correction in study design to preserve the integrity of the study . .
  • 440 Request Info

    Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices

    Efficient and effective management of clinical trials can significantly impact the time, scope and budget for the development of a drug. Project managers must understand the development process and the key aspects of all phases of Clinical Development in order to act, react and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones to achieving proof of concept for any new drug. Phase 3 clinical trials are critical to gain regulatory approval for the market and Phase 4 allows expansion and extension of the indication for a drug. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations. The course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural differences. Guidance for the how-to as well as problem-solving . . .