Fda Regulatory Webinars PowerPoint PPT Presentations

The Webinar will ensure that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes developing a company philosophy and approach, incorporating it into the overall computer system validation program, and plans for individual systems with this capability.

GlobalCompliancePanel is an online knowledge fulfillment community portal. We are providing compliance training in various industries by expert speakers.

GlobalCompliancePanel is an online knowledge fulfillment community portal. We are providing compliance training in various industries by expert speakers

FOOD AND DRUG ADMINISTRATION ... enactment) Suspension of registration ... and products that emit radiation animal feed and veterinary drugs food and cosmetics ...

2024 Best practice for FDA Audit and Inspection webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors. A key component of this webinar is the discussion of the tricks and techniques that inspectors use to elicit information. How you react and respond when they occur could impact your results. Other key communication skills will be presented in the context of the inspection and interpersonal exchanges between inspectors and company associates being questioned. We will complete the webinar by discussing how to handle, in the moment, adverse findings as they are identified by the inspector so as to not compound the issues and severity of the findings.

You will learn what the FDA regulatory hurdles are, how they work and how you can work with them in an efficient and effective way. You will also learn how the U.S. Customs and Border Patrol and FDA work in tandem.

This 2 hours webinar will provide a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Regulatory compliance is a vital requirement in several industries. Its importance in the life sciences is all the more pronounced, given the importance of human lives, with which the life sciences deal. Regulatory compliance is the act of being in accordance with set standards and specifications of the products or services that come from an industry. Regulatory guidelines and requirements are set out by regulatory bodies in respective industries. These regulations are arrived at after painstaking research.

Consumer Credit Protection Act. OMB Circular A-130. FEMA Guidance Document ... Blake v. Woodford Bank & Trust Co. (1977) Foreseeable workload failure to prepare ...

This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.

MakroCare is organizing the webinar on Matured/Established Products Regulatory Support Models by Chand Sishta, Director, Global Regulatory Sciences Matured Products Bristol-Myers Squibb.

Webinar on what the FDA expects for a 510K submission. FDA has initiated methods to ensure that 5 10Ks meet a minimum threshold of acceptability.

Capability to use Excel creates an inexpensive and handy tool for FDA regulated industry, particularly R&D operations and early stage development activities. However, companies frequently struggle with understanding and implementing applicable regulations on spreadsheets. Many companies use invalidated spreadsheets leading to negative audit findings. This seminar will address all these issues by providing methods for planning and executing spreadsheet validations that satisfy FDA requirements. For more details please contact customersupport@onlinecompliancepanel.com

This webinar is intended to help you get familiarized with the best practices for global regulatory intelligence including dos and don’ts.

This webinar will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective.

Webinar on how to identify the non-compliance liabilities within your program and how to respond to direct interview questions on non-compliance issues.

Attend this upcoming webinar to learn about updated FDA rules and regulations of Lab Development Diagnostic Tests, LDT and labeling, marketing practices.

The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cell phones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide which healthcare app is safe?

Webinar will provide an understanding of current expectations of ISO 13485 notified body auditors regarding containment or correction of nonconformity.

The webinar discusses current regulatory expectation on how a firm identifies deviations, investigate the cause, recommend corrective, preventive actions.

4 Training courses on FDA Rules and Regulations for Medical Devices

This course provides guidelines for coaching attendees on best practices for managing vendors, consultants, contractors involved dealing with computer systems.

Have you ever wondered about the FDA strategies for scheduling inspections and pursuing compliance plans? This seminar will provide clarity around those issues from a compliance expert with over 30 years’ experience in inspection and compliance management.

The attendee will learn how to develop a standard approach to managing organizational change when users not only have to accept new processes, workflows and systems, but have to do so in a manner that complies with FDA guidelines for computer systems. In some cases, users will be new to the concept of validation and FDA regulation, and will have to be coached on how to follow the necessary procedures. This is true in the Tobacco industry, where regulations are emerging, but it is also true in pharmaceutical and related industries where IT staffing may not have the skills or training required. It's important to look at what is going to change, what are some of the threats and challenges, and what methods you can use to mitigate these.

The webinar will offer an overview of FDA requirements for marketing, labelling and promotion of OTC drugs in the U.S. It will cover how OTC pharmacy can be effectively marketed and the OTC Monographs and their importance to compliance in general and drug labels in particular. Challenges of marketing OTC drugs in the U.S. will be covered.

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.

In this 60-min presentation, the speaker will guide you through the details of how to identify and use big data for your maximum benefits applicable to FDA-regulated industry.

This webinar will address the best practices for cyber security management for premarket submission purposes concerning medical devices containing software.

This webinar is intended to help you get familiar with how to prepare for and get ready for an FDA inspection.

A must attend webinar for those personnel that require an understanding of the FDA’s expedited programs for serious conditions.

New photography shows activities from the learner's point of view ... In the News. Something to think About. Clear objectives 'You can build on this' ...

Medical device firms need to be aware of the benefits of compliance as well as the dangers of inadequate complaint handling. FDA’s recall authority and program launches you into a project of crisis management.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

If you are part of Regulatory - Labeling team in your company, you should not miss this Webinar. As you are constantly working to coordinate a more robust end-to-end labeling process, and trying to get yourself up to speed on the newest emerging regulations / guidances from FDA and EMA, MakroCare brings you this opportunity to learn about A-Z of Labeling to Global labeling process and practical challenges faced in day-to-day operations from our duo experts Gerrit-Jan Nijveldt, Senior Director, Regulatory Labeling, Sanofi and Carlos Langezaal, PhD, Director, Global Regulatory Affairs, Eisai, Inc.

New FDA Documents -Discussion of Implementation Considerations Monika Kawohl Principal Statistical Programmer Accovion GmbH, Marburg, Germany FDA Submissions ...

Mitochondrial Manipulation Technologies: Preclinical Considerations Wei Liang, Ph.D. FDA / CBER / OCTGT Wei.liang@fda.hhs.gov Ethical and Social Policy Considerations ...

ComplianceOnline webinar on regulatory requirements for adverse event reporting for dietary supplements and OTC products

GlobalCompliancePanel, the flagship brand of NetZealous LLC, a well-known provider of professional trainings in the regulatory compliance, human resources, healthcare and IT areas, offers on-site trainings on a number of areas relating to regulatory compliance.

This webinar will define what is the US FDA's expectations for proper laboratory practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how basic Quality Management System (QMS) expectations/requirements are addressed in the lab environment. The webinar with evaluate pharma GMPs and 21 CFR 58 and associated regulations to see how the GLPs can be implemented in the real world to achieve FDA requirements and ensure the accuracy and repeatability/reproducibility of lab results.

This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.

We will cover regulatory compliance, content marketing, social media marketing, and paid advertising. By the end of this guide, you will have a better understanding of how to navigate the digital landscape and find success with the Digital Marketing Agency for Pharmaceutical Companies.

This webinar will make a distinction between nomenclatures and discuss the reporting requirements to the FDA and Office for Human Research Protections.

To start with, let us put you at ease with the topic of this discussion: “NetZealous LLC at your facility” is not the same as “FDA at your facility”! In fact, if anything, it is only to help originations tide over the tensions associated with a visit from the FDA that NetZealous LLC comes to your facility.

Attend this webinar to learn about when you require a premarket approval for a medical device and FDA approval process for medical devices.

This Webinar will address the specific requirements of FDA CFR Part 820 and ISO 13485 with some further emphasis upon design controls and compliance/enforcement.

This webinar is a must for those personnel that require an understanding of the FDA's 510(k) substantial equivalence determinations.

FDA Medical Device Recalls are an effective method of removing or correcting consumer devices that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from devices that present a risk of injury or gross deception or are otherwise defective.

70% of companies sampled need to comply with 5 or more broad types of regulation ... The Patriot Act. Drivers of change and development. Global Regulatory developments ...

This webinar will present the results of the MDUFA III and will describe how your company will need to do business with the FDA in the next five years.

This webinar is a must for those personnel that require an understanding of the regulations governing laboratory activities relative to nonclinical testing that support or are intended to support applications for products regulated by FDA.

Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation requirements that must be fulfilled in the medical device industry. FDA is getting more and more stringent about product design requirements for risk management and to fulfill its mandate for safety and efficacy of all medical devices.

William Gahl, MD, PhD. www.cettprogram.org. Tests Available NOW ... Obama/Burr Bill. Kennedy/Smith Bill. CMS reneging on CLIA specialty. Two FDA draft guidances ...

This course will focus on three major points: 1.) The regulatory requirements for environmental monitoring 2.) The main issues with environmental monitoring programs such as monitoring locations and the justifications for them, the types of sampling, and the establishment of operational limits and 3.) The handling of excursions and what are some of the common deficiencies cited by regulatory auditors. Register here: http://bit.ly/EnvironmentalMonitoring4Pharma For further details please contact customersupport@onlinecompliancepanel.com or call us on 510-857-5896