Drugs Web-based Seminars

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...

FDA Compliant Practice for Labeling and Off-Label Communication Through Social Media - Webinar By GlobalCompliancePanel ...tion by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans). This webinar will also discuss the FDA proposed and recommended practices for responding to both non-public and public unsolicited requests made through emerging electronic media (e. g., social media or other public electronic media). In addition, several public comments  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...

The Controls for Outsourcing Manufacturing and Testing - Webinar GlobalCompliancePanel The webinar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA regulated industry will be discussed. Of course, regulatory requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance  more...

New Amendments of Critical Parameters in Canadian Clinical Trials - Webinar By GlobalCompliancePanel This presentation will help you to understand the last changes that occurred in Canadian ethics regulations. The presentation will clarify for sites and sponsors how to easy the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the  more...

Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A Part 210-211 - Webinar By GlobalCompliancePanel The manufacture of drugs is controlled by ICH-Q7A and 21 CFR Part 210 & 211. Although these standards were written 24 years apart, they complement each other in many ways. Thursday, September 29, 2011 10: 00 AM PDT | 01: 00 PM EDT  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...

How to Survive a DEA Inspection Series Controlled Substances and Hospitals - Webinar By GlobalCompliancePanel This training will cover several recommendations to improve the hospital's Due Diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.  more...

A Simpler Approach to Implementing or Validating CGMPs to 21 CFR 11 Electronic Records Signatures - Webinar By GlobalComplianceP The verification and validation of electronic records and electronic signature software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of FDA Guidance's, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to  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...

CAPA Challenges and FDA Expectations - By GlobalCompliancePanel CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.  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...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/ DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...ts occurring during the conduct of clinical research with drugs or devices utilizing human subjects. See why AEa ™s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/ his charge. Learn how well-controlled and well-conducted clinical trials that follow the Code of Federal Regulations and the Principles of GCP are important to  more...

Develop and Execute the Company Software VV Program - Webinar By GlobalCompliancePanel Overview: The verification and validation of medical software is coming under increased scrutiny by the U. S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to structure, run, and document  more...

Root Cause Analysis - The Heart of a Successful CAPA Program - Webinar By GlobalCompliancePanel Overview: Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective  more...

Developing the Master VV Plan to Meet US FDA ISO 13485 and 14971 Requirements - Webinar By GlobalCompliancePanel Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different  more...

Controlled Substances and the Hospital Pharmacy - Webinar By GlobalCompliancePanel Overview: This webinar will cover several recommendations to improve the hospital's Due Diligence when dispensing Schedules II through V controlled substances in a hospital setting and what steps that can be taken to detect and prevent the illicit use or diversion of any controlled substance. Objectives of the Presentation: The following areas are covered: * DEA Office of Diversion  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ...s of scientific and journal articles on off-label uses of drugs for many years now, but the regulations and rules in recent years were burdensome, and the Department of Health and Human Services Office of the Inspector General (OIG) has been diligently pursuing off-label promotion as a form of Medicare fraud. In February 2008, the FDA issued guidance that permits the dissemination of medical  more...

Project Management for Clinical Trials - Webinar By GlobalCompliancePanel ...epare a contingency plan for unavailability of comparator drugs in some countries. * Decide on detailed timelines for study preparation, performance, and evaluation, including critical time points. * Start some initial feasibility into the countries of interest. * Ensure investigator brochure is available * Identify and decide on study management technologies and processes  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel Overview: There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard 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  more...

Developing and Using the Product Risk Management FileReport - Webinar By GlobalCompliancePanel Overview: Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation  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 Overview: There is an on-going major shift in the emphasis of U. S. FDA cGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success. The Agency has 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  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...

Validating Excel and Word Applications Documents - Webinar By GlobalCompliancePanel Overview: Both the U. S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e. g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel Overview: This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale. Three of the most common tools will be discussed. One very simple approach  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry)  more...

Basics of OTC Drug Labeling Compliance - Webinar By GlobalCompliancePanel ... 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 OTC Drug labeling regulations and an understanding of how to comply with FDA requirements. Potential FDA enforcement actions regarding OTC drug labeling will also be covered.  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel An overview of the 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  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...rs 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 prior to FDA approval (through changes being effected (CBE) supplements) to ensure consumers are  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G ...c health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for "single-entity" and "co-packaged" combination products. FDA proposes to create 21 CFR  more...

Process Validation for Drugs and Biologics ...ings a new webinar on the topic of Process Validation for Drugs and Biologics. Webinar will be on March 17, 2010. Webinar will be presented by James Harris. Mr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During  more...