Medical Devices
What is IMDRF and What is The Value to Industry to Engage
This event will help you to learnabout IMDRF. The event will allow you to understand the history and the associated stakeholders, including the countries that are actively engaged in the development. You will also learn about where harmonization has been achieved as well as where there continues to be challenges like in device classification, risk and practice of medicine. The event will help OEMs understan..
Role of Cognitive Load in Medical Device Design and Human Error
The webinar delves into the critical nexus between healthcare technology and user performance. The 90-minute session begins with an exploration of cognitive load, dissecting its intrinsic, extraneous, and germane components. By unraveling the complexities of cognitive load, participants gain a profound understanding of how the mental burden associated with interacting with medical devices can impact decisio..
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..
Implementing a Change Control Quality System Successfully
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..
Software development for Medical Devices under IEC 62304
IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to ..
Standards – Fact, Fiction or Fad?
This event will help you to learn what the value of standards are including how and when to engage in the development and use of the standards. You will hear some examples of best practices as well as Faux pas’s. You will learn about the various types of standards and what being involved brings you. You will hear about potential tools and the value of relationships and communications in the standards ..
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance
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 an explanation on how to get from..
21 CFR Part11 Compliance
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t..
5S for Operators
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. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..
Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks
Auditing is a critical aspect of an overall data integrity assurance plan. To successfully audit the integrity of data, auditors must possess specific knowledge, insights, and skills. A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification (which is unfeasible in an industry that generates large volum..
Advertising and Promotional Material Compliance and Review Process
The information obtained will enable the effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..
Answering and Replying to an FDA 483
A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports
FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between the FDA and the EUincludepremarket authorization (CE Mark), complaint investigations, postmarket surveillance, and reports. The EU’s new Medical Devices Regulation (MDR) incorporates more rigorous regulatory requirements for those areas and in some cases outpaces the FDA’s requirements. The FDA..
Extractables and Leacheables in Drug Development
Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risks based on the dosage forms and the administration route. When safety concerns are detected, approaches for the toxicological evaluation of extractable and leachable have been developed and applied by pharm..
From Training to Human Reliability In Manufacturing
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implementing strategies and practices like operational excellence and performance reliability. To achieve this goal, innovative approaches to traditional processes need to take place. This webinar..