WEBINARS

 

Food and Dietary Supplements Regulatory Compliance Training - Live Webinars, Recordings & CDs

CGMP controlled Raw Materials

webinar-speaker   Charity Ogunsanya

webinar-time   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.

Recording Available

* Per Attendee $399

 

Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

webinar-speaker   Travis Austin MacKay

webinar-time   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.

Recording Available

* Per Attendee $279

 

Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations

webinar-speaker   Travis Austin MacKay

webinar-time   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.

Recording Available

* Per Attendee $349

 

Report Writing for Auditing Professionals

webinar-speaker   Phil Vassallo

webinar-time   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.

Recording Available

* Per Attendee $249

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   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.

Recording Available

* Per Attendee $299

 

Measurement Uncertainty in Microbiology

webinar-speaker   Michael Brodsky

webinar-time   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.

Recording Available

* Per Attendee $249

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   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.

Recording Available

* Per Attendee $299

 

Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

webinar-speaker   Travis Austin MacKay

webinar-time   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.

Recording Available

* Per Attendee $279

 

Human Error Reduction in GMP Manufacturing

webinar-speaker   Ginette M Collazo

webinar-time   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.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Karl M. Nobert

webinar-time   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.

Recording Available

* Per Attendee $399

 

Will your food fraud vulnerability assessment pass an audit?

webinar-speaker   Karen Everstine

webinar-time   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.

Recording Available

* Per Attendee $329

 

FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

webinar-speaker   Carolyn Troiano

webinar-time   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.

Recording Available

* Per Attendee $299

 

Process Capability Analysis, and What to Do if it's Not a Bell Curve

webinar-speaker   William Levinson

webinar-time   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.

Recording Available

* Per Attendee $229

 

Risk Management of Source Water used in the Food Industry

webinar-speaker   Michael Brodsky

webinar-time   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.

Recording Available

 

Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products

webinar-speaker   J. Jeff Schwegman

webinar-time   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.

Recording Available

* Per Attendee $299

 

Inexpensive Food Safety and Traceability Solutions Using Process and Quality Control Concepts

webinar-speaker   John Ryan

webinar-time   60 Min

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.

Recording Available

* Per Attendee $249

 

The Most Serious FDA 483s - How to Avoid Them

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $299

 

Food Safety and Security - Ensuring Food Safety from Farm to Fork

webinar-speaker   John Ryan

webinar-time   60 Min

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.

Recording Available

* Per Attendee $229

 

Integrated Food Safety Traceability Systems - Traceability Capabilities, Costs and Trends

webinar-speaker   John Ryan

webinar-time   60 Min

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.

Recording Available

* Per Attendee $249

 

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

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.

Recording Available

* Per Attendee $249

 

 

 

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