This webinar on risk-benefit decisions in medical device manufacturing provides attendees with an understanding of the two recently released FDA draft guidance documents - “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” and “Design Considerations for Pivotal Clinical Investigations for Medical Devices”. It also covers the relationship to regulatory submissions and the risk/benefit analysis important in a Risk Management System. Why Should You Attend: In the increasing scrutiny of the safety and effectiveness medical devices, you and your company need a firm grasp of developing issues. Your quality and regulatory department needs a clear understanding of…

This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US data for discussions with FDA. Description FDA acceptance criteria for non-IND/IDE clinical trials are based on internationally recognized standards of quality, ethics, and practices for human subject protection. An adequately designed non-US study can be used to greatly reduce the time of cost of getting the tested product to the US…

This 6-hr virtual seminar will present a detailed overview of regulatory requirements necessary for establishing a medical device quality system in the US, which is relevant and applicable for quality system management in global jurisdictions of medical device products. Why Should You Attend: Quality is the key to success in business. This is no exception for the medical device industry! It is imperative that medical device industry fully understand the regulatory requirements, which are relevant and applicable to the quality of the products so that each and every requirement can be defined, documented, implemented and maintained in an effective manner.…

This 90-minute training on the FDA system based inspection technique will focus on the responsibilities of the laboratory within the systems based inspection approach and will help the personnel in the quality control laboratory understand their role in the new FDA focus on Systems. Description FACT: Many organizations do not understand the FDA move to Systems Based Inspections. One of the focus areas for many inspections is the laboratory and it is important that laboratory personnel understand the FDA system based inspection technique and the type of things the FDA will look at when they decide to investigate the Laboratory…

This Sterility or Bioburden test Webinar/training will discuss on various items that should be investigated to determine the root cause and the follow up to the investigation. Why Should You Attend: All sterile products require some level of sterility and bioburden testing during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet specifications can be critical from a regulatory and safety standpoint. You need to know what and how to investigate during these potential failures or out-of-specification conditions to identify the root cause. You also need to know if…

This 90-minute webinar on Part 11/Annex 11 audit and enforcement will tell you what the auditors are trained to look for during a Part 11/Annex 11 “tag along” audit. It will cover inspection trends with examples of some recent 483s and warning letters and show what you need to do to have a successful inspection outcome. Description Regulatory compliance requirements for CFR 21 Part 11/Annex 11 (also known as ERES) have undergone several revisions since its inception during the late 1990s. While the agencies have endeared themselves to the industry by adopting a flexible audit approach for ERES, they are…

This 120-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. Description This webinar is designed to provide participants with a lifecycle approach to developing and validating analytical methods. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises. The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the…

Why Should You Attend: This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement. The DMF section will explain preparation and explain the types of information essential for any Drug Master File. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular…

Course Description: Learn from successful case studies on how to Transfer a Medical OEM Molding Operation to a world class molder and Transferring an Assembly Operation from one OEM supplier to another manufacturer with Validated Systems and Processes. This 2-day seminar will provide valuable assistance and give a process and procedure to all regulated companies that are transferring equipment, molds, dies, systems and processes to suppliers. It will show how quality, verifications and validations process will meet today’s standards for the FDA and CE Mark. This interactive workshop will guide you in the procedures and process of transferring equipment, tools…

This 90-minute webinar on compliant foreign manufacturing facilities will help you understand the problems that can occur with foreign manufacturers of pharmaceuticals. Recent inspections and enforcement actions by FDA have brought the topic into greater focus. Why Should You Attend: The FDA regulates foreign manufacturers of pharmaceuticals to be imported into the United States. Remote monitoring of quality assurance parameters can present challenges for foreign manufacturers in Central and South American and Asia. Failure to comply with FDA standards can lead to extremely large fines, enhanced scrutiny, and rigid monitoring. Proper determination of stability characteristics and expiration dates must be…

This 90-minute webinar on medical device quality assurance practices will review robust quality assurance principles and teach you techniques and lean methods to help you implement FDA Quality System Requirements. Why Should You Attend: Quality assurance work force is considered as the bearer of bad news. It should be the bearers of good news. They can anticipate adverse events and near misses before they happen and prevent them from happening. This seminar emphasizes elegant solutions to quality improvements resulting in high return on investment. This is one of the good news management is looking forward to. Then your organization can…

This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner. Why Should You Attend: To be able to achieve sustainability and to remain sustainable and competitive in global medical product markets, it is necessary to streamline regulatory compliance processes, in particular, the Good Clinical Practice (GCP) for clinical trials and studies and beyond. To establish and maintain GCP, it is critical to accurately define, document…

This OSHA inspection webinar will cover aspects of an OSHA inspection from how establishments are targeted, how to limit the scope of an inspection or investigation, how not to self-incriminate, and when and how to appeal. Why Should You Attend: An OSHA inspection can be a costly and disruptive experience for any employer, especially if that employer has not dealt with the Agency, does not have an in-house safety professional or attorney. An OSHA inspection that goes badly essentially says the employer has a defective safety program, is not sufficiently focused on the safety and health of its employees, or…

This Disinfection and Cleanroom Cleaning training will teach you how to choose the best disinfectants, know the different performance parameters of disinfectants, methods to qualify disinfectants, writing and executing cleaning procedures. Areas Covered in the Seminar: * Disinfectants commonly used in the industry, their modes of action, efficacy, and toxicity. * Understanding the nature of contaminants in the cleanroom and which disinfectants will be effective against them. * Benefits and drawbacks for using each type of disinfectant used in the Pharmaceutical Industry. * Bodies that regulate disinfectant manufacturers and testing required by manufacturer’s for label claim. * Learn disinfectant testing…

Course Description: Do you use a Contract Sterilizer for your medical device sterilization? Are you not an expert in industrial sterilization? If you answered “yes” to either of these questions, this seminar is a must for you and your team members. The FDA and your Notified Body will look to you, the medical device manufacturer, for the answers to deficiencies in the sterilization process whether sterilization is performed at your location or at a contract sterilizer. In this seminar you will be provided a basic understanding of radiation and EO sterilization processes and validation methods associated with both methods. Typical…

Why Should You Attend: This presentation begins with an overview of the biological self versus non-self mechanism resulting in the anti-drug response of biopharmaceuticals. The next section describes how to differentiate the risk associated with internal attributes of the drug from the risk derived from external factors. That guideline in conjunction with the latest industry recommendations and regulatory guidelines provides a logical approach to the risk strategy. The second-half of the presentation demonstrates how to use pre-clinical results to further characterize (but not predict) the immunogenicity response and utilize this information to be ready for adverse effects during clinical trials.…

This 90-minute webinar will help you understand the 510K process including some history about 510ks versus PMAs and give you the necessary information to know when to file a 510k, as opposed to a PMA, or to not file any 510K of a new or existing medical device. Why Should You Attend: FDA is responsible for overseeing entry into the market of all medical devices. All devices, unless exempt, must go through a pre-market review for safety and efficacy. Anyone who wants to be a player in the medical device market must have a sound understanding of what is expected…

This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. Why Should You Attend: This webinar will address frequently observed issues and problems with method validations. Validated methods are required for Phase III of the drug development process. Moving methods from the development phase to the validated phase ready for sample analysis does not always occur without unforeseen issues arising. Differences in laboratories and analysts, as well as instrumentation can contribute to delays in validating methods. Setting appropriate specifications and criteria based on…

This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times. Why Should You Attend: The Clinical Research Coordinator (CRC) plays a key role in the site’s success at audits/inspections, and must therefore know how to ensure the site is ready for an audit or inspection at all times. In order to ensure audit/inspection preparedness, the CRC must be aware of the applicable regulatory and sponsor requirements, guidelines and SOPs, and ensure the conduct of…

This 3-hr virtual seminar will discuss the requirements and compliance in medical device adverse event reporting and medical device surveillance/vigilance system in the US, Europe and Canada. It is designed to help the audience with their global compliance in adverse event reporting and surveillance/vigilance system during pre- and post-marketing. Why Should You Attend: To be able to achieve sustainability and to remain sustainable and competitive in global medical device markets, it is necessary to streamline regulatory compliance processes, in particular, the Adverse Event (AE) Reporting during clinical studies and post-marketing. Thus, to establish and maintain a medical device AE reporting…