Drug Web-based Seminars

SUBSTANCE ABUSE AND THE ADA WHAT YOUR MANAGERS NEED TO KNOW ...such as handling substance abuse in the workplace. Active drug users in the workplace can impact productivity and cause attendance and absenteeism problems in addition to performance issues. Find out whether these workers are protected by the ADA and what your supervisors should do to manage substance abuse issues that occur. Recovering Alcoholics and Drug Addicts also can cause issues. Find  more...

GMP for Phase 1 Products - Webinar By GlobalCompliancePanel Overview: This presentation will cover the contents of the guidance that was given. FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP. Tuesday, August 7, 2012 10: 00  more...

GMP Compliance for Dietary Supplements - Webinar By GlobalCompliancePanel Overview: The U. S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. Wednesday, June 13, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

First in Class First in Man Compounds Targeting Tumor Bioenergetics from Lab Bench to Clinical Trials Working with the FDA to me Overview: Many anticancer drugs are not tumor selective. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting. Preventing a therapeutic level to be achieved in a patient. Thursday, June 28, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Lipid Based Formulations and Targeting Tumors - FDA Considerations of Nanotechnology in Drug Manufacturing Drug Delivery and Dru Overview: Many anticancer drugs are poorly soluble and require higher dosing to achieve some level of delivery to tumors and tumor cells. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting. Tuesday, June 12, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

RAPS Approved Seminar on Microbial Control Monitoring and Validation of Pharmaceutical Water Systems at Mumbai Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary  more...

RAPS Approved Seminar on Complying with GMP and CGMP Requirements Streamlining Quality Assurance and FDA Compliance at Mumbai Overview: Each lecture will be 90 min in length. There will be morning and afternoon breaks of 30 min each which will be reduced to 15 min, if needed to accommodate long lectures. Lunch will be at least 1 hr in length. The instructor will be available for questions and discussions during all breaks and lunches and will also be available for a minimum of 30 min at the end of each day. The  more...

Essentials of Drug Safety and Pharmacovigilance - Webinar By GlobalCompliancePanel This webinar is designed to give pharmaceutical and biologic companies operating in the U. S. and EU an introduction to the fundamentals of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities. Thursday, April 19,  more...

Preparation for FDA EU Pharmacovigilance Inspections - Webinar By GlobalCompliancePanel This webinar is designed to give pharmaceutical firms operating in the US and EU practical information, practices and insight to help ensure compliance with the most recent drug safety and pharmacovigilance regulations. Tuesday, April 3, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Title 21 Code of Federal Regulations for Food and Drugs - Webinar By GlobalCompliancePanel Overview: United States Food and Drug Administration ("FDA") is the federal agency responsible for ensuring that foods are safe; drugs for human and animals, biologics and medical devices are safe and effective; electronic products that emit radiation as well as cosmetics are safe. Thursday, March 29, 2012 10: 00 AM PST | 01: 00 PM EST  more...

FDA Compliance for Drug and Medical Device Labeling and Off Label Promotion What is Acceptable or Not Acceptable - Webinar By Gl Overview: This webinar is intended to discuss the best practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). Wednesday, March 14, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Business Process Optimization in Pharmacovigilance - Webinar By GlobalCompliancePanel Overview: This webinar will describe how to assess and optimize Pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the  more...

Challenges that must be Considered When First-in-Human and Subsequent Phase I studies are Contemplated - Webinar By GlobalCompli This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process. The FiM and other Phase I studies set the tone of all future Pre NDA studies. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Drug Development Process - From Discovery to Marketing - Webinar By GlobalCompliancePanel This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. Wednesday, February 15, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Reusable Device Cleaning Disinfection and Sterilization Validations Overview and Key Design Considerations for Device Engineers Validation of reusable medical devices requires that the manufacturer develop methods for cleaning (after use) washing to remove all foreign matter possibly disinfecting and repackaging for the next use. The diversity of medical devices their intended use and classification in accordance with the food and drug administration requires that the manufacturer develop and validate the reprocessing  more...

Risk Analysis for Portfolio of Drug Development Programs - Webinar By GlobalCompliancePanel Building in strategic risk scenarios into portfolio planning can buffer the organization against the unexpected. Examples might be clinical trial failure, shifts in the marketplace or insufficient resource capacity. This webinar covers various portfolio planning tools and techniques with a focus on strategic risk management. Thursday, February 2, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Portfolio Optimization for Global Drug Development - Webinar By GlobalCompliancePanel ...s selecting the "best" portfolio of internal and external drug development programs for funding and balance company resources including money, manpower and manufacturing capacity. Projects could be interdependent, have multiple development scenarios, and are subject to multiple business rules specific for the company environment. Value of each project depends on multiple factors, and could be  more...

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC ...cts are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDAa ™s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both  more...

Why is Drug Induced Liver Injury an Important Mirror of Drug Safety and How to Spot this early - Webinar By mentorhealth Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1: 10, 000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. Wednesday, November 30, 2011 10: 00 AM PST | 01:  more...

The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...

Surviving a DEA Inspection by a Hospice Program BY GCP The Drug Enforcement Administration (DEA) has been focusing on the prescribing of Schedules II narcotic substances by practitioners caring for their patients in a certified Hospice Program where narcotic drugs are prescribed for the individual patient.  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a ...dentiality, fitness for duty evaluations, when and why to drug test, the relationship between conduct problems and mental illness, and how to directly address mental health problems with managers and employees. Why you should attend: Rrisk of litigation if psychiatric disabilities aren't handled correctly, mental illnesses are one of the most treatable disorders but only a third of  more...

ISO 13485 as a Quality Management System for Medical Devices by GlobalCompliancePanel This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

The Law and Psychology of Mental Health Issues at Work Substance Abuse Depression and the Bermuda Triangle of the ADA the FMLA a This workshop helps HR professionals understand how to navigate the difficult and often murky challenge of dealing with "invisible disabilities." To make matters more confusion, the recent amendments to the A. D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. This practical workshop address both the legal and psychological issues  more...

Adverse Event Reporting for Dietary Supplements and OTC Drugs - Webinar By GlobalCompliancePanel Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs. Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to  more...

The Risk to Subject Safety of Not Accurately Reporting Adverse Events - How to Assess and report AEs and SAEs - Webinar By Globa The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately.  more...

What to Expect and How to Prepare for FDA Inspections - GlobalCompliancePanel ...cent headlines demonstrate, non-compliance with US Food & Drug Administration US FDA laws and regulations could cost your firm millions. In addition to significant revenue losses, violative US FDA inspections may also lead to injunctions, consent decrees, warning letters, FDA 483 's Notice of Inspectional Observations, product non-approvals, import detentions, recalls, criminal  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is clear. Covered also will be what the  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ... manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ... 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ... Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the FDA processes and why the Sponsor's / CRO's Monitors are so important. Areas Covered in the Session: * What doe the FDA look at when Auditing/ Inspecting a study? * The  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ... for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485: 2003 will find themselves very closely compliant with FDA's Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...n a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/ or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities. Rapid  more...

Elements of the Lot Disposition Process - Webinar By GlobalCompliancePanel ...tem procedures for the disposition of intermediates, API, drug substances, medical devices, finished product, and in-house manufactured components. It will describe a well-defined Quality role, identify requirements for resources, and outline the expectations for documentation review. Additionally, the course will look at the creation of disposition packages for approval and rejection of  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel ...eceiving/ shipping order forms and invoices, inventories, drug destructions, and theft/ loss reports. * DEA Security Requirements: This section covers the steps that a hospital can take in order to be in full compliance with the security requirements. Why you should attend: Understanding DEA regulations is important and the steps suggested in this training will give you a better insight  more...

FDAs New Process Validation Guidance - Webinar By GlobalCompliancePanel ...verhaul of FDA's primary validation standard brings U. S. drug. API, and biologics process validation up to par with the advanced and modern expectations of European authorities and CDER's sister medical device division. The new requirements expand validation from a one-time activity into a full lifecycle philosophy, encompassing statistics, risk management, project management, and new  more...

Recruiting is Critical to Your Success What is the Secret - Webinar By GlobalCompliancePanel Overview: This presentation will go over the steps required for your recruiting process to be successful. The ability to bring in (recruit) on-time study participants whether they be 'normal healthy adults' or patients with the condition being studied is essential for a CRO, a site, a CPU/ CRU for conducting on-time study starts with the full complement of volunteers. For this reason the  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel ...Drug, and Cosmetic Act history basics will be covered as will implementing FDA regulations relevant to the Food, Dietary Supplement and OTC Drug industries that have followed. Some more recent major new regulations such as the Dietary Supplement Health & Education Act (DSHEA), the Bioterrorism Act, and the Food Safety Modernization Act will also be covered. Areas Covered In the Seminar:  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally. In addition to the regulatory and criminal consequences of off-label promotion, companies that promote off-label may be  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...idence of the disease, where do you propose to market the drug * Identify potential locations for the study (eg which countries have a high incidence of the disease, where do you propose to market the drug * Obtain statistical input to calculate sample sizes and prepare the statistical plan. * Ensure availability of suitable non-clinical and clinical research data (eg Phase 1,  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...e under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based. Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger,  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ... come under increasing negative publicity due to multiple drug recalls and pulling of product off the market, importation of tainted foods, lead based paint in toys, and recent public concern over insufficient oversite of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to "shoot itself in the foot", including once highly respected  more...

Utilizing Good Requirements as a Foundation for the Effective Validation of PDMA-related Computerized Systems - Webinar By Globa ...sm for compliance to the requirements of the Prescription Drug Marketing Act (PDMA), while accomplishing this with a manageable level of effort. However, these systems can get bogged down during implementation due to the need for excessive validation testing and documentation. This, in turn, can lead to lengthy and sometimes fatal delays for roll-out to production. How can such systems be  more...

Controlled Substances and the Pharmacist - Webinar By GlobalCompliancePanel ...The public media has been reporting the abuse of narcotic drugs prescribed for pain management with its focus on the legitimacy of prescriptions and the dispensing by a pharmacist. Both federal and state regulations have placed the responsibilities on the physician who wrote the prescription and the pharmacist who filled the prescription. Today's pharmacists will need to familiarize  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...iting times, the use of foreign sites is appealing to all drug developers, especially generic and 505(b)(2). Due to shortcomings found during site inspections, lack of inspection resources and the general tightening of FDA safety reviews, FDA has started imposing some a unwrittena requirements for the acceptance of such data. This webinar explores these requirements and how you can ensure  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...on products as 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. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each  more...

Webinar on Pharmacovigilance Audit - Webinar by GlobalCompliancePanel ...drug safety and pharmacovigilance audit, including compliance with applicable worldwide laws, regulations and guidance. In addition, attendees will learn how to compare the company's pharmacovigilance operations to applicable best practices. The course will cover all aspects of drug safety and pharmacovigilance compliance including the collection, assessment and reporting of adverse event  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order.  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ... process + Japan's Effort to Reduce "The Drug Lag" + Japan's Desire to Eliminate Bridging Studies and Participate in Ph. III Global Trials Agenda for Part II: Japan - Understanding the Dynamics of the Changing Structure, Regulatory Requirements and Compliance Processes for Life Science Products * Marketing Authorization Processes a Filings &  more...

ISO 13485 as a Quality Management System for Medical Devices - Webinar By GlobalCompliancePanel Overview: This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485: 2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel ...rticipants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U. S. will also be covered. Why should you attend: Anyone who wants to market OTC drugs in the U. S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/ webinar. It will provide background for  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel ...drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel ...on products as 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. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each  more...

Project Management for the Phase 3 LCM Life Cycle Management of the Drug Development Process - Webinar by GlobalCompliancePanel This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running phase 3 clinical trials.  more...

GMP Expectations for Products Used in Early Phase IND Studies - Webinar by GlobalCompliancePanel 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. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...a-analyses, the new regulation states." FDA requires that drug, biologics, and medical device manufacturers obtain FDA approval of their warning labels before the drugs or devices are marketed and sold. Manufacturers generally must also obtain FDA approval before making changes to labeling information. However, in limited circumstances, companies can revise or supplement their warning labels  more...

ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ... 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections..." The  more...

European Drug Safety and Pharmacovigilance Compliance - Webinar by GlobalCompliancePanel This webinar will describe European PV requirements, including compliance with applicable laws, regulations and guidance. In addition, attendees will learn how to compare the company's PV operations to applicable best practices in Europe.  more...

Navigating Pediatric Trials from recruitment to successful on-time completion - Webinar by GlobalCompliancePanel ...Drug companies face many challenges in pediatric clinical research. Pediatric trials come with a high level of complexity and cost. In order for professionals to carry out a successful pediatric drug development plan, they need the right infrastructure and information to avoid obstacles such as slow recruitment, noncompliance and difficulties in developing the right study criteria and  more...

FDAs New Enforcement of 21 CFR Part 11 - Webinar by GlobalCompliancePanel FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just from 2007 to 2010, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003  more...

Signal Detection and Case Processing Business Process Optimization in Pharmacovigilance - Webinar by GlobalCompliancePanel ...y perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings. The methodology has helped companies increase compliance at reduced cost. The scope covers all pharmacovigilance  more...

Managing the IDE Investigational Device Exemption Submission for Compliance Success - Webinar by GlobalCompliancePanel An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to  more...

The FDA Tripod - Clinical Trial Regulations Compliance and GCP in Drug Development - Webinar by GlobalCompliancePanel This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms,  more...

Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel ...tinue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers. It's in everyone's self interest to improve the quality of investigations and CA/ PA. This webinar will provide regulated companies the core principles and practices needed to implement an effective and efficient CA/ PA process. This presentation will begin by defining risk in  more...