Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
Travis Austin MacKay
Product Id: 702154
This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.
Ginette M Collazo
Product Id: 704107
This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
Dr. Afsaneh Motamed Khorasani
Product Id: 705131
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Product Id: 703814
Skilled auditors require a method that aligns what they experienced during the reviewing process with what they compose during the writing process. This report writing workshop will provide foundation resources that participants can continually turn to during intense, complex audit engagements.
Dr. Afsaneh Motamed Khorasani
Product Id: 705130
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Product Id: 705148
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food
Karl M. Nobert
Product Id: 702224
This webinar will provide an introduction to FDA rules governing manufacturing, testing, labeling and marketing of pet food in the U.S. In addition to facility inspections and product recalls, the webinar will summarize and assess FDA’s enforcement activity in the U.S. pet food market paying particular attention to enforcement trends and risks.
Product Id: 706066
The webinar will provide you with valuable information about setting up a food fraud vulnerability assessment so that you are better prepared to meet the food fraud-related requirements of GFSI Certification Programme Owners and the economically motivated adulteration requirements of the U.S. Food Safety Modernization Act.
Product Id: 705097
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
Product Id: 705157
This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.
Product Id: 703211
This training on source water protection will address the issue of source water protection and the potential impact on the food industry. Attendees will learn the best practices for the protection of source water and risk management from a microbiological perspective.
J. Jeff Schwegman
Product Id: 702893
This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.
Product Id: 705497
This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.
Product Id: 701866
This Food Safety system webinar focus on how effectively basic process and quality control concepts that can be implemented in time in any food handling operation.
John E Lincoln
Product Id: 702766
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
Product Id: 701812
This food safety webinar will discuss the currently accepted food safety practices and how the newly evolving system for food safety is about to be put in place.
Product Id: 701598
This Food Safety system webinar will discuss how the current traceability capabilities, costs and trends will become integrated into food safety systems and explore the different approaches like Barcode, RFID, Manual systems, simple tagging etc.
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents
John E Lincoln
Product Id: 704848
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
David L Chesney
Product Id: 704933
This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.
Product Id: 703902
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.