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.
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.
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.
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.
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.
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.
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.
How to undergo an FDA Inspection Successfully
Marie Morin
90 Min
Product Id: 705170
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
FSSC 22000 Food Safety System Certification
Farhad Mehrabi Nejad
90 Min
Product Id: 705479
To be certified with FSSC 22000; a food manufacturing needs to implement processes that address all the Requirements of FSSC 22000. This Webinar lumps together the Processes including Resources and Trainings needed to implement FSSC 22000.
Safe Drinking Water - Another Oxymoron?
Michael Brodsky
60 Min
Product Id: 703944
This training program will discuss the sources and causes of waterborne disease and what microbial options are available to assess and minimize the risk.
FSMA Foreign Supplier Verification
Bryan Armentrout
60 Min
Product Id: 704952
This webinar will teach you what is expected under the new requirements of the Food Safety Modernization Act. Every food company that manufactures or supplies food under FDA jurisdiction is now or will be required to have a Foreign Supplier Verification Program in place.
3.5 hr Virtual Boot Camp: How to Survive an FDA Food Facility Inspection
Angela Bazigos
3.5 hrs
Product Id: 705520
This Virtual Boot Camp will provide an overview of the FDA inspection program, how to prepare for an inspection of your facility and the FDA program that applies to foreign food facility inspections.
Novel Foods Regulation in the European
Vicente Rodriguez
60 Min
Product Id: 705495
Learn what foods or food ingredients are considered 'Novel Foods'. Learn about novel foods applications, pre-marketing authorization procedures and the assessments required to demonstrate safety.
Making the Connection between FSMA and GFSI Requirements
Miranda Peguese
90 Min
Product Id: 705061
This webinar will explore the complex relationship between GFSI and FSMA and will outline how GFSI certification can help manufacturers reach regulatory compliance.