This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.
You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state. In addition, you'll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology.
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.
Effective regulatory strategy, like product design, requires "quality-by-design" approach and planning throughout the product development lifecycle. For pharmaceutical, device, and biotechnology companies, understanding how to effectively design and manage a regulatory submission can lead to a more efficient application development process and greatly increase the likelihood of marketing authorization.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
In this webinar speaker will review the user fees themselves in more detail and discuss the performance goals established as a result. And finally, she will devote the bulk of this presentation to highlighting the program areas addressed with the passage of MDUFA IV.
FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 3 years FDA issued more than 30 warning letters with Part 11 related observations. Citations are related to inadequate integrity, security and availability of electronic records, including data manipulation.
There are many questions about the ongoing inspection and enforcement program, e.g., what inspectors are looking at, what are major findings and what are the FDA expectations about follow up.
The Behavioral Based Safety system (BBS) is a valued tool used in conjunction with other safety and health aids, such as, job hazard analysis, fault tree analysis, audits, and inspections. The BBS focuses on the behavior of the worker which is measurable and observable, unlike a person's attitude.
When behavior which can cause accidents and organizational loses are observed, the BBS system will give aids to the safety officer in coaching safe behavior. The final output of an effective BBS system is to create a safety culture.
In this webinar We will explain the role of Risk Management in Non-Product Validation, understanding how to avoid major mistakes when validating software to FDA standards, This webinar will review the validation planning process with emphasis on avoiding common pitfalls, The attendee should leave the presentation confident in their ability to improve the level of validation success.
Risk Management is a regulatory and statutory requirement for medical devices. The generic procedure to perform risk management is outlined in ISO14791, however, as soon as software is used challenges arise. How to address these specific software issues and the application of FDA and IEC requirements for development of safety-critical software used in medical devices is the content of this seminar.
The larger, more complex, and longer your project is, the more likely some aspects won't work out as you envisioned.
You have the greatest chance for success if you confront the possibility of unexpected changes head-on and if you plan how to minimize the consequences of those changes from the outset.
After developing your schedule, you need to plan your resource allocation. Planning your personnel needs begins with identifying whom you need and how much effort they have to invest. This analysis provides you with a clear description of accountability and responsibility, a way to track costs and work assignments, and an identification of when too many or too few resources are being assigned.
You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. In this 3-hour webinar, you'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally 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 occurrences.
This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. This webinar can help you create a design control process that is a competitive strength for your company.
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.Understanding the requirements of Part 11 is critical to compliance with the regulation.Knowledge of regulatory requirements is an exercise in efficiency both efficiency in project management, and avoidance of non-compliance penalties.
The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Examples of device changes and recommendations for documenting a company's decisions are provided. FDA provides a series of flowcharts and questions that can serve to guide medical device manufacturers to come to a conclusion as to whether a new 501(k) is necessary.
This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You'll learn how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.
However, all production processes exhibit variation that is, no two items are identical. What method can be used to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".