How to Prepare a Standard Operating Procedure (SOP)?
Dr. Afsaneh Motamed Khorasani
60 Min
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.
US FDA's Cybersecurity and NIST Framework Requirementsfor Networks
John E Lincoln
90 Min
Product Id: 706971
Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry.
P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3
John E Lincoln
90 Min
Product Id: 706963
This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.
Cybersecurity - The Latest US FDA Requirements
John E Lincoln
90 Min
Product Id: 706949
Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry.
Performing Effective Management Review of the Quality System
David L Chesney
90 Min
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.
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
Travis Austin MacKay
120 Min
Product Id: 702317
This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.
Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
Travis Austin MacKay
90 Min
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.
CGMP controlled Raw Materials
Charity Ogunsanya
90 Min
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.
Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations
Travis Austin MacKay
60 Min
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.
Report Writing for Auditing Professionals
Phil Vassallo
90 Min
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.
Measurement Uncertainty in Microbiology
Michael Brodsky
60 Min
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.
Human Error Reduction in GMP Manufacturing
Ginette M Collazo
90 Min
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.
Good Documentation Guideline (Chapter <1029> USP)
Dr. Afsaneh Motamed Khorasani
60 Min
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.
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
90 Min
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.
Will your food fraud vulnerability assessment pass an audit?
Karen Everstine
60 Min
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.
FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products
Carolyn Troiano
90 Min
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.
Process Capability Analysis, and What to Do if it's Not a Bell Curve
William Levinson
60 Min
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.
Risk Management of Source Water used in the Food Industry
Michael Brodsky
60 Min
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.
Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products
J. Jeff Schwegman
90 Min
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.
The Most Serious FDA 483s - How to Avoid Them
John E Lincoln
90 Min
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.