Industry Specific Training Courses

Overview: Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.

Overview: This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including: How to link risk with the confidence statements associated with the sampling plans Identify a variety of sampling plans, that all make the desired confidence statements

Overview: How does the new standard impact laboratories that are already accredited and how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?

Overview: This course will outline the issues that need to be considered in the preparing to respond to disasters, and will suggest ways to minimize impact to the business and to maintain consumer safety. Why should you Attend: Consumer Safety is paramount in the food industry, which an industry that is heavily regulated by domestic and international authorities such as the FDA, EPA etc.

This six-hour seminar will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.

E-mail has long been a staple of people's lives, but as we move into the new digital age, it seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used for health care purposes, including the use of e-mail and texting. Doctors are finding that texting is far more flexible, convenient, and effective than paging, and patients want to be able to use short message texting for handling of appointments, updates, and the like, where even e-mail or the telephone would seem inconvenient.

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject. The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

Do you work with children or adolescents with autism who exhibit behaviors that interfere with their ability to effectively and efficiently navigate their environment? They may appear willful, obnoxious, overreactive, anxious, or unfeeling or withdraw. They may lose control of their ability to cope or regulate their behavior which can send them spiraling into a meltdown. You may feel helpless, frustrated, and powerless after each meltdown. Drawing on 45 years of experience and research based strategies, Kathy will lead the viewer with many practical strategies to prevent the meltdown, as well as intervention strategies and how to address post-vention strategies. Many videos demonstrating the examples will be presented to help support and demonstrate the strategy.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices. Why you should attend Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.

Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

This 6-Hour Virtual Seminar will get into the fine details of what we need to do and how to do it. We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers.

Why you should attend Many statistical softwares are now available to professionals. However, these softwares were developed for statisticians and can often be daunting to non-statisticians. How do you know if you are pressing the right key, let alone performing the best test? This seminar provides a non-mathematical introduction to biostatistics and is designed for non-statisticians. And it will benefit professionals who must understand and work with study design and interpretation of findings in a clinical or biotechnology setting.

This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance. Why you should attend This is an area of growing concern, sometimes ridden with uncertainty as to what needs to be done at each of stages of the Product Lifecycle. In modern Pharmaceutical and Biotech laboratories, a composite array of various gadgets, devices, analytical instruments and computerized systems are used daily.

Overview This course is to emphasize the importance of QUALITY in pharmaceuticals: The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraint, demands for efficiency, development of international regulation, supply chain complexity, and product/process complexity. In this fast-changing environment, the people and companies that learn to adapt will prosper To manufacture & deliver consistency zero-defect products to the patients.

Overview A person working machinery gets distracted can end up in a danger situation. A person staring out of their office window can end up wasting hours in a day and causing their productivity to slide. Office meetings can be disrupted by someone blurting out an answer before the question is fully out. Making meeting run on and wasting time Managing a person's attention in a work environment raises productivity, enhances office moral and increase performance on multiple levels.

Learn the necessary information on how to address conflicts and behavioral issues in the workplace by attending this session. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Behavioral-Issues-Conflict-Incivility-in-the-Workplace-A-New-Era-in-2019-503920/APRIL-2019-ES-TRAININGREGISTRY

Overview: CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.

Overview: Learn to properly prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization. You will learn how to both prepare and review the continuity planning program. Areas such as IT Outsourcing and other risks will be covered. It is critical to assess the IT and Information Security risks and the effectiveness of the institution's risk management processes as they relate to the security measures.

Overview: This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.

Overview: This webinar will help you develop a quality control program that fits your microbiological laboratory's needs. We will explicitly not cover any serological, immunological or molecular tests. Why should you Attend: In microbiology laboratories, there are a wide array and media for all sorts of use. From clinical laboratories, to environmental monitoring, from research laboratories to industrial labs, there are a large number of different set-ups. These media and reagents need to be monitored on a regular basis to ensure that the work performed in these laboratories is accurate and true. Otherwise, false results will be reported, which can lead to serious consequences and harm the public health in a myriad of ways.