Agency Web-based Seminars

The Interactive Agency Emerging Media and Design - Online Course Curious about interactive agencies, check out this course at UCSD Extension, Digital Arts Center Today's marketing and advertising worlds are quickly moving to digital with both online and offline campaigns being directly impacted by emerging media channels. Led by Digitaria Interactive Executive Vice President Warren Raisch, this course is intended for creative individuals from digital arts,  more...

Prepare for Tougher cGMP Compliance Audits - Webinar By GlobalCompliancePanel Overview: This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs. Wednesday, June 20, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

FDA Inspections - Dos Donts - Webinar By GlobalCompliancePanel Overview: The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that your products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful inspection is being prepared to communicate how your quality systems assure this state of  more...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectations - Webinar By Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out  more...

Writing and Maintaining Quality Standard Operating Procedures SOPs to Guarantee FDA Compliance - Webinar By GlobalCompliancePane A cogent understanding and thorough knowledge of the regulations for SOPs is a necessity for product development and clinical testing organizations with the goal of agency approval, and product commercialization. Thursday, March 15, 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...

The Investigational Medicinal Product Dossier IMPD EU CTA vs FDA IND Comparing the Content and Agency Expectation - Webinar By G This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective  more...

FDA Inspections - Dos Donts - webinars by gcp The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

FDA Inspections - Dos Donts The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.  more...

Good Documentation Practices for Laboratory Operations - Webinar By GlobalCompliancePanel ...s of non-compliance. During this webinar, you will review agency and industry standard expectations of Good Documentation Practices plus see examples of these practices (both good and bad!) as they apply to the pharmaceutical laboratory. Why Should You Attend: Discover what the FDA and EU regulations say about documentation Learn what your signature and/ or initials mean on a  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...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 statement clearly reflects the renewed FDA interest in examining industry  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Gods Administration (TGA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA) * Use of comparability protocols * Submission strategies * Concept of research exemptions Who Will Benefit: * Microbiology * Quality Control * Quality Assurance *  more...

Tougher US FDA cGMP Compliance Audits - When Youre Not Ready - Webinar by GlobalCompliancePanel ...ance 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 recent public concern over insufficient oversite of new product introductions (and grandfathered product) by means of the 510(k) system. Business continues to  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ... 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) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...ining for industry has been available from any regulatory agency or official (governmental, nongovernmental or industrial) organization. Unfortunately, this lack of guidance may cause some in industry to think that training is a simple process. However, for training to be an effective and efficient tool that contributes to performance, it must be done properly. Areas Covered in the Session:  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...equires 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. Specifically, section 519(e), as added by SMDA, required  more...

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli ... + PMDA (Pharmaceutical and Medical Device Agency) + PAFSC (Pharmaceutical Affairs and Food Sanitation Council) o Patents and Trademark Considerations * Beginning Your Company Involvement in Japan o Local Office and Personnel Requirement Options o Language Requirements o Possible License Types * Objectives of  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel ... 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) need to do internally. A review of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to  more...

The FDAs Working Group Reports I II - New Directions - Webinar by GlobalCompliancePanel ...rview: This webinar will examine 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) need to do internally. Examination of two recently published reports by the FDA's CDRH (devices) have identified major areas of concerns: 1) 510(k) Working Group's Preliminary Report and Recommendations, and 2)  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...sent. The rule also provides clarification as to what the Agency considers to be new information to be incorporated into a label change. Specifically, new information "must reveal risks of a different type or greater severity or frequency than previously included in submissions" and includes meta-analyses, the new regulation states." FDA requires that drug, biologics, and medical device  more...

The Most Common Problems in FDA Software Validation Verification - Webinar by GlobalCompliancePanel ...d 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 statement clearly reflects the renewed FDA interest in examining industry  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product Determine which Center will review my combination or non-combination product? These topics and more will be addressed during this Webinar,  more...

Preparing for and Surviving an FDA Inspection - Webinar by GlobalCompliancePanel ...cation activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the arrival of an investigator for an  more...

Key Modules of an Effective CAPA SOP - Webinar by GlobalCompliancePanel ...Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs, especially CAPA. It will examine how these goals of the Agency have translated into action in the past half year, with trends evident in 483 observations and Warning Letters. A key to effective relations with the FDA is the emphasis on proving a company is "in control" to an  more...

Asphalt Pavement Management Recycling Preservation Online Certificate Program The Asphalt Pavement Management, Recycling & Preservation Online Certificate Program consists of three modules covering pavement evaluation, management, recycling and preservation. Those who are faced with the challenges of maintaining roadways on a shrinking budget will learn cost and energya efficient strategies to extend the useful service life of pavement. The instructor, Blair Barnhardt, has  more...