The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.
This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received.
You will learn about the key components in managing complaints such as tracking the complaint from time of receipt to completion, initiating and performing a complaint investigation, evaluating the complaint for medical device reporting, final review of the complaint and investigation and preparing a response to the complainant.
Too often Project Leaders and Managers fall into the role due to demonstrated technical competence. After all, if you're competent enough to create great technical output, certainly you can figure out how to run a project on schedule and within budget, right? And even when you get an opportunity to attend training to become a better Project Manager, the focus is on the "hard" or technical aspects of project management rather than the "soft" skills or habits that typically only come with experience.
This webinar will examine the changing focus of medical device regulation, similarities and differences between ISO 13485 and 21 CFR 820 (FDA's Device CGMPs), We will establish the correct definition of "risk", tied to ISO 14971 which has led to some major issues with companies selling to both the US and the EU.
Several trends will influence business. For this presentation we are looking at three specific ones, and their impact on quality management and quality tools. The first trend is digitization, not just of business processes but also of society at large.
A second trend is speed of change and reduced product life cycle time and linked to this a reduced time to improve a product after it has been released to the market. The third trend is the continuous increase of intelligent automation through Artificial Intelligence (AI) and self-learning systems.
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 as described in the FDA Guidance 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 to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
The webinar provides a comprehensive overview of the mechanics of clean room HVAC, It is important that a clean room's HVAC system is fully understood, properly designed and properly validated, The webinar then provides valuable information on differential pressure, air velocity , flow rates, and air pressure balancing, Finally, a full set of requirements for HVAC system validation is detailed.
This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU. Prior to engaging the process of establishing and certifying a QMS for medical devices or enhancing the QMS to the newly introduced requirements, a review of those requirements and how to approach them is important.
This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.
FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused. As of December 2016, FDA and CBP officially implemented the Automated Commercial Environment (ACE) entry filing system. You either meet ACE requirements or face entry refusals and monetary penalties of up to $10,000 per offense. Other factors can derail the expectation of a seamless import entry process. The course covers detailed information about the roles and responsibilities of the various parties involved with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking, negotiate with the FDA and offer anecdotal examples of FDA's import program curiosities.
The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.
Why should you Attend:
The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
AA is used to estimate the useful lifespan of a product or its shelf life when actual lifespan data is unavailable. The ability of product designers to accurately predict changes in polymer properties is of critical importance to the medical device, consumer, and industrial markets.
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
What critical thinking means
Why it's important
How it relates to you in the workforce
How better thinking skills can help you
How you can learn to think critically to make decisions and set goals
To examine the fundamentals of critical thinking, problem solving, decision making and goal setting
To explore the relationship between critical thinking and career self assessment
To help participants make informed and wise decisions
To help participants approach problem solving and decisions making effectively
In this webinar expert speaker’s James Zack will help you to identify several types of owner claims against contractors and the elements of the burden of proof required of all claimants. The basic requirements concerning damages are covered. The webinar will conclude with an outline of various dispute resolution methodologies.
The first is the ability to design the organization to match the intended or desired outcomes, and second, the ability to recognize when the initial direction of the organization is different from the desired outcome and follow the necessary steps to correct this mismatch. Organizations that are able to do this are exemplary.
This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System, how to best approach CAPA (including initiation, evaluation, and follow-up verification), examples of documentation you can use to fulfill the CAPA requirement, as well as tips and tricks to what FDA auditors will look for when they come to visit your site.
Communicating and enforcing dress code policies are essential. Learning to set and manage policies by working directly with internal managers, business partners and executives in handling issues such as inappropriate or provocative dress, unhygienic employees is important, as well as identify and mitigating any legal issues.
Travel pay computations can be complex and confusing, even for experienced payroll professionals. The FLSA and state wage and hour laws require employers to pay employees for all hours worked and include all hours worked in computing overtime compensation. An employee's total hours include all time spent doing work for the employer including time spent traveling on behalf of the employer.
In this webinar expert speaker, Patrick Haggerty will discuss what employers must know, which hours must be compensated, which payments must be included in the regular rate of pay, and how to compute the correct amount of overtime compensation.
In this session, industry veteran James G. Zack, Jr., will discuss impact damages and what they may include. You will gain a better understanding of impact damages and the issues surrounding this form of damages. This session will also explore 10 types of impact damage claims. For each of the 10 types of impact damage claims, Zack, Jr. will identify and discuss one or more potential defenses owners may employ to analyze and resolve impact damage issues.