All FDA Regulated Industry
Applying Risk-based Approaches to Processes Under the Quality Management System
Just about every process in the QMS can be driven through risk-based thinking. Creating a simple and effective plan is key to a successful application. This discussion will outline specific proven approaches to specific processes, ensuring both a rigorous approach and one that is acceptable to auditors/inspectors.Areas Covered The “big” ones: purchasing, training, computer system validationOthers: Aud..
Training Requirements and Practices to Assure QSR and ISO Compliance
A complete and effective employee training program must be in place to assure training requirements are established, implemented, and verified. This session will instruct attendees on the regulatory requirements of personnel training, and the establishment of a training program, including new employee training, methods of training, and how to document training so that it is readily available for review (by ..
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the ..
FDA Finally Outlaws Soda Ingredient Banned Around the World
For several decades, vegetable oils have been touted as healthy and the use of a brominated vegetable oil (BVO) as an ingredient would not normally have raised any concerns. BVO is a vegetable oil that is modified with bromine. Up to now, its use has been authorized by the FDA in small amounts to keep the citrus flavoring from separating and floating to the top of some beverages.Dietary supplements and food..
Good Documentation Practice and Record Keeping Regulations (FDA and EMA)
Good documentation Practices (GDP) are an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules an..
-80x90.jpg "Human error reduction in GMP manufacturing/floor")
Human error reduction in GMP manufacturing/floor
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall h..
Regulatory Strategy in The Pharmaceutical Industry: Paving the Way From Concept to Commercialization
Regulatory strategy in the pharmaceutical industry refers to the plan put in place by a pharmaceutical company to ensure compliance with laws, regulations, and guidelines set forth by regulatory agencies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe or any other relevant drug regulatory authorities.Some key components of a successful reg..
-80x90.png "Artificial Intelligence (AI) impact on Quality organization and regulations")
Artificial Intelligence (AI) impact on Quality organization and regulations
This course is designed to equip Quality Units (QU) within GxP (Good Practice) regulated organizations with the necessary tools and knowledge to maintain compliance with both local and international regulations. By leveraging AI systems, participants will learn how to enhance daily functions, streamline processes, and uphold the highest quality and compliance standards.Areas Covered Understanding GxP Regula..
Most Valuable Non-Technical Skills for Scientists
Soft skills, those non-technical and non-scientific understandings that help a person effectively interact and communicate, are based on knowledge that is completely separated from what work goes on in the laboratory. But they are often key to a project’s success or failure. If the end user of the data does not understand the data or the caveats that are part of it (uncertainty, accuracy, etc.) then the exp..
FDA Guidance on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
Up to now, the FDA would consider a product adulterated upon its finding objective evidence that the manufacturer was in violation of FDA regulations.However, the actions of an owner, operator, or agent to prevent or delay an inspection left open the possibility that the product would not be deemed adulterated precisely due to the FDA’s inability to obtain such evidence.On July 9, 2012, the Food and Drug Ad..
Non-Product Computer Software Validation
Non-product software validation is one of the most misunderstood processes in the medical device industry. In reality, software validation should be something that companies embrace! The whole intent is to ensure that the software does what it’s supposed to do, is robust enough to handle whatever its users do, and can be maintained for the life of the software. So why all the consternation? Typically, it’s ..
Best Practices in Preparation for an FDA Computer System Audit
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it ..
How do you use FDA Guidance Documents and Recognized Standards – Perspective of a Consultant?
This event will help you to learn about the FDA’s Guidance Documents and their recognition of standards. The FDA is the regulator for medical devices, and they want to ensure products are safe and effective. An optimal way of doing so is through the use of standards. Standards are developed by a cross-section of personnel from clinical and technical areas. The FDA is one of those stakeholders which allows t..
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.Areas CoveredCompu..
5 Key Components of Good Manufacturing Practices to obtain cGMP certification
Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilities to meet the standards for a product to be deemed safe, pure, and effective. Good Manufacturing Practices are critical to any organization that produces products for the public. This training will discus..