Food Web-based Seminars

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...

Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims Updates from the FDA - Webinar By GlobalC ...our products 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 An update on FDAa ™s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling  more...

Intelligent Routing for Temperature Sensitive Goods - Webinar By GlobalCompliancePanel The session will cover strategies to provide real-time cold chain temperature tracking and traceability.  more...

Preventing Food Safety Problems BY GCP Most industries have become reasonably sophisticated in terms of applying the principals and tools involved in quality control and improvement.  more...

ISO 13485 for Medical Device QMS by GCP This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485.  more...

Excel Spreadsheet Validation to Eliminate 483s by gcp This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.  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...

What to Expect and How to Prepare for FDA Inspections - GlobalCompliancePanel ...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 investigations and prosecutions, seizures, compliance problems,  more...

Product Recalls - Planning and Conducting Food Recall - Webinar By GlobalCompliancePanel Creating an effective Product recall process that will protect both the consumer and company's/ brand's reputation requires careful planning and active involvement of each involved department.  more...

Understanding ISO 13485 vs ISO 9001 for Successful QMS in Medical Device Industries - Webinar By GlobalCompliancePanel ...written 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,  more...

Navigating the Regulatory Environment for the Implementation of Alternative Microbiology Technologies - Webinar By GCPanel ...implementation * Current perspectives from the U. 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 *  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel ...Food, 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  more...

Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel ... Promoting a 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  more...

Meet FDA Expectations for a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel ...sing 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, higher profile  more...

Change Control -- Your Companys GMP Weak Point - Webinar By GlobalCompliancePanel ...ective 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  more...

Food Safety Management Systems - ISO 220002005 - Webinar By GlobalCompliancePanel ...w: This presentation will assist organizations within the food chain to understand the requirements to meet the international standard for Food Safety Management. Areas Covered in the Session: The following areas will be addressed: * Key terms and definitions * General Requirements * Documentation * Management Responsibility * Resource Management * Planning  more...

Chemical Control for Food Manufacturers Ingredient Cleaning and Hazardous Materials - Webinar By GlobalCompliancePanel ...e in this area due to the recent focus on biosecurity and food safety. Learn and teach your team to implement a world class program that will protect your organization and exceed your customers expectations. Areas Covered in the Session: * What types of materials are to be considered * Acceptable control levels * Methods and tools for control * Review * Quiz Who  more...

Internal Audits Maintaining your Quality Systems at the Ready - Webinar By GlobalCompliancePanel ... audits are a core component of the Quality Assurance and Food Safety program. Ensuring the team representatives are trained and calibrated is a critical aspect of the program. An untrained team will miss important audit items, compromising the confidence in the companya ™s ability to assess and improve its own systems. Why you should attend: Maintenance is often found to present the  more...

Operational Risk Management Ensuring Safety for Food Systems - Webinar By GlobalCompliancePanel ...today's movement into more and more serious controls over food safety and security, the liabilities associated with recalls and deaths are creating new approaches to determine and reduce the likelihood of risks associated with contaminated foods. Risk assessment involves determining where and what types of risks are involved throughout any food process, assigning quantitative values to those  more...

Preventive and Corrective Maintenance Protect your assets Protect your consumers - Webinar By GlobalCompliancePanel ...t the greatest area of opportunity for improvement in the food safety chain. Lack of control of parts and condition of equipment often contributes foreign material to the product resulting in costly product recoveries. Untimely repairs affect productivity as well as customer order fulfillment. A systematic approach to maintenance is critical to operations, quality and safety. Areas  more...

Medical Device Tracking Latest FDA Update and Expectations - Webinar By GlobalCompliancePanel ...Food and 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 ...ncy) + 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 the Rules Governing Medicinal Procedures o Market  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...

How to Prevent Food Safety Problems Using Your Current Quality System - Webinar by GlobalCompliancePanel ...ved in quality control and improvement. Unfortunately, food supply chain members have lived outside of the quality world and have not invested the time, training or money to learn and apply the disciplines needed to bring quality into preventive levels of control. Visual inspection in many industries has long ago been rejected as a means of quality improvement since it is expensive and does  more...

Crisis Management and Risk Communication - Webinar by GlobalCompliancePanel ...issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes and how well it succeeds in today's highly competitive marketplace.  more...

Microbiological Foodborne Threat - Risk Mitigation and Crisis Management - Webinar by GlobalCompliancePanel As your company's system continues to grow, the potential for "crisis issues" to occur grows proportionally. The concern for food safety to your customers and employees must be a constant area of focus for all operators in the system. Ultimately, how well your company manages the crisis situations it will make a significant difference in how your company brand is perceived in the public's eyes  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...

Food Traceability Program and Efficacy Verification - Webinar by GlobalCompliancePanel ...Food Safety and Quality standards as required by BRC fundamental clause 5. 0, SQF item 4. 5, 9 CFR will be covered. The purpose of traceability and its value to the brand will be explored. The resources necessary to achieve an effective result will be presented. A customer perspective on the importance of product traceability from a customer perspective will be shared with the attendees to  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...

A Guide for Compliance with Document Control Requirements for Food Manufacturers - Webinar by GlobalCompliancePanel An essential part of the Food and Site Security Plan and the Bioterrorism Act. of 2002 section 306. The control of food safety and quality records as required by customers, regulators and internal audit and legal disciplines.  more...

Foreign Material Control GlobalCompliancePanel brings a new webinar on the topic of Foreign Material Control. Webinar will be on March 9, 2010. Webinar will be presented by Melinda Allen. Ms. Allen is a Food Safety and Quality Consultant in the Food Industry. Melinda has had a long and dedicated career of Quality Assurance and Food Safety leadership with companies such as YUM Brands and Quiznos.  more...