Training Courses, Classes, Seminars and Webinars

The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.

Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environmental Monitoring Program requirements, Excursion investigations, DataTrending, Microbiological processes/methodology, Cleanroom cleaning/disinfection.

The one-day workshop provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter. The workshop gives you hands on experience to understand UDI and your device. You bring a laptop computer and some information about your device. During the seminar you receive toolkits to determine the compliance dates, packaging configurations, and the attributes you will load to GUDID

Learning Objectives: Regulatory guidelines for Clinical Data Management Best practices for data collection CDISC/CDASH/STDM standards Responsibilities of personnel Case report form criteria Maintaining confidentiality of data Data storage and transferability Data preparation and quality assurance for accuracy Data monitoring plan criteria Data systems validation Adverse event reporting and coding criteria What to expect on a monitoring visit Troubleshooting and resolution of deviations from plan Who will Benefit: Study Investigators Data managers Data processors Statisticians Site Personnel Clinical Research Associates Clinical Project Managers/Leaders Study Sponsors Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management Staff in the above fields who work with data collection/management and require training in CDM. Compliance auditors and regulatory professionals who require a knowledge of CDM in asse

Who will Benefit: This seminar will provide valuable assistance to all personnel in: Automotive, Electronics, Medical devices, Chemical, Toys, Industrial machinery Manufacturing Professionals Anyone new to RoHS and or REACH and need to understand the regulations. Anyone responsible for RoHS and REACH compliance. Quality Managers, Environmental Managers, Purchasers, Buyers.

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

Pharmaceutical and life sciences companies are under an extreme amount of pressure to maintain an ever-increasing amount of regulation and legislation. With this pressure, they still need to increase efficiencies, bring new products to the market faster, reduce prices, deliver innovation, ensure patient compliance, and maintain business compliance.

Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment.

The Drug Master File (DMF) is a valuable repository of confidential information which can be stored at the FDA by a product manufacturer in the pharmaceutical industry. The DMF summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product development. FDA guidance documents are available to assist with development of the DMF components, but translating the FDA regulations and guidance documents into actual practices reflecting current product development can be challenging. Expertise and diligence are required to determine which documents need to be created, stored and updated over time in the DMF at the FDA for support of marketing applications made by others using the company product. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. Learn how to achieve more successful biocompatibility testing outcomes by attending this seminar. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

The accounts payable function is changing at a dizzying pace. Technology, new frauds and regulatory changes are all taking their toll. What worked yesterday may not work today. Given the current business environment, mounting regulatory pressures, and the increased visibility and importance of the accounts payable function, best practices are something with which every professional needs to be conversant. Unfortunately, keeping up to speed these days can be like herding cats. While some best practices remain steadfast, others simply no longer work and are being replaced by new practices just now appearing. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.

With companies everywhere eyeing the bottom line, insistence on compliance with travel & entertainment policy is becoming more commonplace. What's more, the IRS has also been taking an equally harsh stance, so compliance must now not only be to the company policies but also IRS rules. Otherwise, you could end up answering not only to the CFO but also the IRS–and that is truly ugly.

Join us In-Person in Greenville, SC or Online via Live Stream / Webinar for our Instructor-Led 2-Day Associate in Human Resources Generalist Certificate Program. This course not only provides you with the training and knowledge you need to become an effective HR Generalist but also prepares you for the aPHR Exam! We meet from 10am to 5pm EDT Monday June 24th, 2019 and June 25th, 2019. If you are registering to participate Online Via Live Stream / Webinar then the training materials will be shipped to you and you will receive an email with the information you need to login to the Live Webinar once you register. For everyone else joining us Live you will receive your training materials when you arrive at the training.

Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.

Whether you are a seasoned supervisor or a newly promoted manager, the Foundations of Leadership program is designed to develop the fundamental skills needed to lead teams and help team members achieve higher levels of passion and productivity. You'll walk away with practical, easy to implement tools and techniques and a new sense of possibility and purpose. Extraordinary leaders can bring a company's vision boldly to life. We can help you become one.

The concepts and information presented will be mainly concerned with statistical quality control: obtaining information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts and acceptance sampling systems and procedures.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.