Clinical Trial and Clinical Research
STED - File: How to Improve Your Technical File
The STED-File with the special format as technical documentation covers a lot of countries and help to have technical documentation in global acting companies. A STED-File collect all the data’s and can help you to keep the overview to deal with this format regarding the several requirements in countries, which required STED-Format e.g. Australia, Canada, etc. Another topic is how to deal with the STED-Form..
Step by Step Process for Successful Sterility Failure Investigations
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, the environment, and the like. As such, there is no one size fits all investigation. Microbiological testing covers a wide range of products, processes, an..
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your par..
Test Method Validation – The Lifecycle Approach
This webinar will help personnel in the Analytical Method Development Laboratory, Quality Control Laboratory and Quality Assurance understand the evolving expectations for analytical method validation. The paradigm that test method validation is one experiment performed just before method transfer must be replaced with a proactive, lifecycle approach that includes the three stages of Analytical Method Proce..
The FDA Inspection: Preparation, Performance and Follow-Up
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discu..
The Human Error Tool Box: a Practical Approach to Human Error
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 manipulated reducing the likelihood of these occurrenc..
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..
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..
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..