All FDA Regulated Industry
The New EU-Medical Devices Regulation (745/2017)
The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class, participants will be introduced to the new requirements in the Medical Device Regulation (M..
The New ISO 14971 - How to Create a Risk File for Medical Devices
This course will give an introduction into the new ISO 14971 and how to create a risk management file according to the ISO 14971. The course will give you an overview of the requirements and how a smart implementation of these requirements in your product documentation is possible and finally what are the expectations of the European Notified Bodies.Areas CoveredWhat is the Medical Device Single Audit Progr..
The Risks Embedded in Using Social Media for Product Promotion
What a firm can say in social media and what an individual can say, are two different worlds, but it is easy to jump unknowingly from the individual to the corporate world of what is legally acceptable to FDA. Firms need to extrapolate corporate boundaries for how they can use and not use social media. What a firm says and how firms deliver a message are equally laden with risk. And ripe for FDA’S administr..
US National Bioengineered Food Disclosure Act (GMO Labeling)
The new rule was highly anticipated by industry and will hopefully bring clarity to the long-standing GMO questions, cover financial and risk impact to businesses as well as helping consumers with educated food choices based on science, in short session encapsulates everything industry needs to know on launching the NBFDSA.Areas Covered Background on US GMO (Genetically Modified Organism) LabelingBasi..
USDA New Proposed Rule on BioEngineered (GMO) Food Disclosure
The USDA announced the National Bioengineered Food Disclosure Standard on December 20, 2018. The National Bioengineered Food Disclosure Law, passed by Congress in July of 2016, directed USDA to establish this national mandatory standard for disclosing foods that are or may be bioengineered. The standard will provide a uniform way for food manufacturers to disclose whether food or its ingredients were bioeng..
What to Expect with the New FSMA Internal Adulteration Regulation
IA establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm. The session will explain coverage, summarize requirements for facilities that manufacture, process, pack or hold human food. Also, exemptions will be discussed as well as best practice approaches and Food Defense Qualified Individual detail.Areas Covered Food defense plan..
What You Should Know About Export Requirements for FDA Regulated Products from the US to Foreign Countries
This training will provide an in-depth explanation of FDA-Regulated Products that were exported from the United States to Foreign Countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products. Then, it also will discuss the FDA procedures that exporter must comply with in order to meet the Modernization Act agreement. Lastly, it explains what local g..
Writing and Enforcing Effective Standard Operating Procedures (SOP)
This course addresses how to write effective SOPs, and work instructions in support of your company's activities.Learning ObjectivesFood and Drug Administration (FDA), the International Organization for Standardization (ISO) requirements for documentationEffective written SOPs and work instructionsMandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the Int..
Writing and Revising SOPs for Increased Operational Efficiency
This webinar will highlight important fundamental knowledge for writing effectively in the context of clear, concise, effective SOPs. This webinar will also help focus on an efficiency mindset that can lead to operational gains without sacrificing quality. This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficienci..
Writing SOPs to Enhance Understanding and Compliance
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective. You will learn techniques for creating concise and easy-to-read SOPs that your employees can understand and will follow. Well-written SOPs result in more consistent process output an..
Writing Validation Master Plans: Best Practices for Authoring a Compliant Document
This webinar will discuss the major components of Validation Master Plans. It will discuss how the VMP is different from Validation SOPs. Various regulatory requirements for Validation Master Plans will be discussed as well as effective guidelines for authoring a VMP and a team writing approach to authoring a Validation Master Plans will be discussed. Various types and examples of VMPs will be given and dis..
Writing World Class Compliance Documentation
Standard operating procedures and work instructions can be an effective tool in the control and standardization of operations, the conduct of training, the meeting of all regulatory requirements, and as user support tools to guide individual performance and to manage the execution of that performance. The key is in knowing how to apply the proper techniques to their creation.Standard Operating Procedures an..
You Must Comply With the USDA Final Genetically Modified Organism (GMO) Label Rule
The need for GMO labeling has been a hot topic for over 15 years. Scientific inquiry regarding the safety of GMO products has generated more questions that have been answered and has added fuel to the controversy.After extensive review and industry input, the National Bioengineered Food Disclosure Law) PL114-216) was signed into law on July 2016. The rules impact many types of food including beer, dairy pro..