The OSHA Voluntary Protection Program (VPP) is the highest award in Health and Safety Excellence that OSHA presents to an organization. This training program will guide attendees with best practices in implementing the OSHA VPP program.
There are five cornerstones or elements for VPP: Management commitment; Employee involvement; Workplace Analysis; Hazard Prevention and Control; and Training.
Define the key elements and sub elements of the OSHA VPP program
Learn how to get a baseline of the safety culture within your facility
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described.
Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional analyses and tests that FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar you will learn the testing that is required in addition to functional tests to produce a validated software product.
This is part 1 of a three part required training resulting from the finalization of new US FDA food transportation laws.
Session 1, "Responsibilities of the Carrier Under the Final Rules" covers the Final Rules on the Sanitary Transportation of Human and Animal Foods (now law) as published by the Food and Drug Administration under the Food Safety Modernization Act (FSMA). This session covers the final rules. All carrier transportation operations personnel are required to take this and the subsequent two training sessions.
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.
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
Why should you Attend: Almost all manufacturing and development companies perform at least some process validation studies, but it is difficult to decide how many Lots to include in the study and how large the Sample per Lot should be.
This webinar provides a "statistical" justification and method for determining Sample Sizes, and a statistical justification for using only 3 Lots (which is the typical number, especially in industries regulated by the FDA).
Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
Why should you Attend:
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.
This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes.
Why should you Attend: We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.
FDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
If the information can reach a consumer,FDA cares, even if you did not publish the information. Firm's need to watch for promotional trespassers. Websites, chat rooms, op-ed articles or even your own postings in social media can cause your product to be misbranded, i.e., illegal.
These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.
Why should you Attend:
Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance.
Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.Careful consideration of the work that will be performed at the laboratory provides a working framework for the content of the audit.
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.
Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.
Use our proven model to quickly assess the financial condition and results of operations of any business using trend and ratio analysis. Join C-suites and business analysts from around the country and empower your team to maximize the benefit from your crystal clear understanding of the numbers.
In today's competitive business climate, health care organizations and their business associates should be able to focus on growing their businesses and not worrying about HIPAA Compliance. Staying up to date on the newest health care information and acquiring new patients takes time.
HIPAA compliance takes time. But both goals can be accomplished - in fact, a good compliance program can make you even more competitive because compliance helps protect and grow your business and sets you apart from your competitors. For example, knowing how to use social media and electronic communications within HIPAA rules is key to staying competitive.
Legal compliance can get confusing when some legal regulations seemingly overlap or even seem almost contradictory to implement. This is the case when the Americans with Disabilities Act (ADA), the Family and Medical Leave Act (FMLA), and Workers’ Compensation intersect.
The intersecting of these three laws is complicated and open to problems if not handled correctly. ADA, FMLA and Workers Compensation have different goals and protections for employees, yet all three have provisions that may require an employer to give job-protected time off when the right circumstances are met.
When new drugs or devices are tested in humans, the data generated by, and related to, these trials are known as clinical data. This data represents a huge investment by the biopharmaceutical or device company and is one of its greatest assets. It is this data that will eventually make a new product both useful as a treatment or therapy and marketable.
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. As its importance has grown, clinical data management (CDM) has changed from an essentially clerical task in the late 1970s and early 1980s to the highly computerized specialty it is today.
By attending this webinar Participants will gain awareness of key signs and symptoms of compassion fatigue and burnout, while learning how to manage stressors and their consequences, This webinar focuses on understanding each of these challenges, their similarities and differences.
In this webinar John is conducting an online training session that will provide you with the proven strategies you need to stay out HIPAA hot water, HIPAA Compliance: Avoid Text/Email Danger Zones - you will be surprised by what can land you in serious trouble, This electronic communication can simplify life and complicate your HIPAA compliance.
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.