All FDA Regulated Industry
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..
Tobacco Industry Trends for Computer Systems Regulated by FDA
The Tobacco Control Act went into effect by the FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (..
Trial Master File – Clinical Data Systems
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content, and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). This seminar will help you understand in detail the new requirements for trial ..
Understanding Human Error in Manufacturing: Methodology for Investigations
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be controlled reducing the likelihood of these occurrence..
Understanding Initial IND Submission - The First 30 Days
This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for an initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical hold. What’s more; the options/ ways to respond to the clinical hold are also discussed to help the sponsor effectively work toward the resolution ..
Understanding the Drug Supply Chain Security Act: Latest Regulatory Developments and Best Practices
The Drug Supply Chain Security Act (DSCSA) outlines requirements for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers. Some requirements began in November 2014 and several key requirements began at various stages in 2015. The requirements, development of standards, and the system for product tracing will continue to be phased in until 2023. H..
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..
Verification, Validation, Master Planning for U.S FDA and ISO 13485 Compliance
How can companies address the U.S. FDA’s tougher stance and product, process and QMS V&V? One major failing is the lack of sufficient or targeted risk-based V&V Master Planning. Why do companies need a Validation Master Plan? What is it? How is it structured? Supporting systems/documents? How should each individual V&V plan be structured? Clarification of validation terms. Device, product, proce..
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..
Write It Right – Well Written Procedures Are Essential For QMS Effectiveness
The webinar will help you to write clear, unambiguous, and flexible SOPs. You will learn techniques for creating easy-to-read and understand SOPs that your employees can consistently follow.Well-written procedures are a critical ingredient in an effective and efficient quality management system. They are an essential part of meeting the regulatory requirement to “establish and maintain” a suitable and effec..
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 Effective Standard Operating Procedures and Work Instructions
Standard Operating Procedures and work instructions – the documentation required by regulation – are essential to the effective and compliant running of any regulated business. Unfortunately, many individuals in those businesses miss the valuable opportunities that properly developed Standard Operating Procedures/Work Instructions can provide. Regulated documentation can serve a variety of purposes other th..