PharmiWeb.com - Global Pharma News & Resources

Events

OVERVIEW The Fair Labor Standards Act (FLSA), commonly referred to as the Wages and Hours Act, is considered to be an employee protection act. This Act was passed in 1938. Since then, the FLSA has been amended many times. The major provisions of the Act are concerned with Federal minimum wage rates, overtime payments, child labor, equal pay, and recordkeeping. The US Department of Labor, Wage & Hour Division, oversees federal labor laws. Additionally, State DOLs administer state labor laws. Failure to comply with FLSA rules and regulations may result in the employer paying the employee back wages, damages, penalties, attorney fees and court costs, plus the prospect of civil and criminal penalties from federal and/or state governments. Therefore, Wage & Hour compliance is of the u…
Overview: Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system. Why should you Attend: A detailed description of a typical pharmaceutical compressed air system with its individual components is provided. Engineering schematics are included. All component functions are detailed with recommendations as to which component type is considered optimal. Areas Covered in the Session: Pharmaceutical Compressed Air System Design Contamination Types and Sources Contamination Prevention International GMP Testing Standards Testing Methods and Specifications Who Will Benefit: Quality Assurance Environmental Monitoring Microbiology Manufacturing Validation Engineering Maintenance …
This webinar will recap the situation currently and will further elaborate on aspects that have not been highlighted thus far, including the consequences for international clinical trials, importing and exporting medicinal products, and more.
This webinar will recap the situation currently and will further elaborate on aspects that have not been highlighted thus far, including the consequences for international clinical trials, importing and exporting medicinal products, and more.
OVERVIEW STOP - Do not put out another hiring notice until you fully consider the ramifications of diversity and inclusion in the workplace.  Why is this important? First, if you have diverse customers, those customers will relate to the diverse employees helping them or selling to them. Second, to avoid a homogeneous culture where people want to fit in so desperately that they will not stick their necks out and make creative or out-of-the-box suggestions. Before you hire, evaluate the people on your teams at the present time and consider what would make the team stronger, then write your hiring notice to ask for the qualities that need to be strengthened. Understand how to create an inclusive culture to retain those people with promise that just joined your company. Inclusi…
Overview: Learn the common EU rules that have been established to ensure that personal data has a high standard of protection across the EU. Why should you Attend: Every day within the EU, businesses, public authorities and individuals transfer vast amounts of personal data across borders. Conflicting data protection rules in different countries would disrupt international exchanges. Areas Covered in the Session: How EU Data Protection Regulation affect social networks How EU Data Protection Regulation benefit existing European business How EU Data Protection Regulation strengthen the internal market How EU Data Protection Regulation impact international co-operation Who Will Benefit: Anyone that has Cause to Exchange Client or Patient Data with a European Location Re…
OVERVIEW One of the most important concepts and criteria of Good Laboratory Practices is accuracy, how well does a methodology stand in terms of quantifying when compared to an expected value? There are various approaches in calibration and in the use of standards for comparisons. This webinar will cover validation of calibrations and the strengths, weaknesses, and appropriateness of the different types of standards. Without accuracy, a result is not acceptable. There are many issues that have an effect on accuracy and there are many approaches to deal with them. The importance of response, matrix effects, selectivity of identification, and other issues will be covered. WHY SHOULD YOU ATTEND Accuracy is one of the most fundamental assessments in regulated analyses and calibration…
Overview: This 3-hour webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. We will go into detail about the 5 biggest "gotcha's" related to compliance with this enigmatic law. I will also speak of multiple litigated cases I have been involved with involving HIPAA compliance (or lack thereof). Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.  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 regarding the do's…
Overview: Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use. Areas Covered in the Session: Preventive Maintenance Requirements Calibration vs. Maintenance: When to use Which One? Remedial Action for Out-of-Calibration Equipment Use of Calibration Standards to Save Cost Who Will Benefit: Engineering Management Production Management Manufacturing Engineering Staff Design Engineers Reliability Engineers Calibration Technicians Maintenance Personnel Speaker Profile: Over that time, He has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. T…
Course overview The General Data Protection Regulation (GDPR) came into force on 25 May 2018 and brought substantial changes to the rules around personal data and its use. Most companies have implemented the requirements, such as creating records for personal data processing activities and preparing data protection assessments. However, while the GDPR built on existing data protection legislation, it represented a significant change for organisations that hold and process personal data including clinical trial data. Also, the requirements apply to companies based within and outside of the EU, including the US. To ensure effective compliance, pharmaceutical, biotechnology and device organisations, universities and hospitals involved in clinical trials and vendors (includi…
Overview: Many people work with various aspects of healthcare coding and billing but may not understand how providers generate their claim data, how they report the data to payors, and how payors use that information to reimburse providers. This webinar provides a high-level overview of all major aspects of healthcare coding, billing, and reimbursement. We discuss key data elements of the two major claim forms (CMS-1500 and UB04) and how that information tells the story of the patient’s encounter with the provider. We review the major coding systems including CPT, HCPCS, ICD-9, ICD-10, DRG, and APC, and examine how codes in each system are assigned and the purpose of each system. We review the typical process flow for how a provider submits a claim and gets reimbursed. We discuss the…
In this webinar, featured speakers will explore: Common bottlenecks and submission errors in the IRB submission process The growing trend of using centralized IRBs for multisite studies How the trial master file (TMF) reference model can be utilized to create a standard language for the exchange of documents for IRB submissions, approvals and notifications How workflow-based technology can be integrated with IRB processes to accelerate the submission process and reduce submission errors
OVERVIEW California statutes pertaining to meal and rest periods for non-exempt employees is one of the more confusing topics in today’s business environment. This course is designed to provide you with a practical foundation for understanding the law. It includes guidelines for how to properly create and administer your own meal and rest period policy. Or, if your company already has its own policy, then this information can help you review your existing policy as well as the procedures and practices in “real life” daily operations. By the end of the course, you will be informed about the California employment law so that you will be better-equipped to assist your company in being California-compliant with meal and rest periods. WHY SHOULD YOU ATTEND Cal…
27-Feb-2019 - 27-Feb-2019
Date: Wednesday February 27, 2019 Time: 10:00 AM PST | 01:00 PM EST Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, new congressional mandates and any other applicable updates for 2019 and beyond.  There are an enormous amount of issues and risks for covered entities and business associates these days - we will speak to the most common violations and fines - and how to best avoid fines and headaches.  I will speak on specific experiences from over 18 years of experience in working as an outsourced complianc…
OVERVIEW Refine your organizational skills to keep your projects on time, on budget, and on target. You've learned the basic techniques of project management. You've mastered the planning, executing, reviewing, and revising skills making the difference between success and absolute failure. You are good at getting the different players and stakeholders to provide information or direction and to show up for important milestones along the way. Now you're ready to hone your organizational skills, communicate even more effectively, avoid major project pitfalls, and work well with others to meet project deadlines and objectives. Build on your fundamental knowledge and expand your capacity to balance day-to-day work and these special PM assignments. You will learn advanced…
Overview: This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors. Why should you Attend: Explain the difference between Aseptic and Bulk processing Understand facility and personnel requirements necessary to maintain microbial control Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product Understand the gowning requirements associated with different cleanroom classifications Areas Covered in the Session: Review Clean Area Behaviors Personnel gowning requirements Good clean area behaviors/practices Practices to avoid – and why Who Will Benefit: E…
OVERVIEW When was the last time you thought about how to positively influence others in the workplace — how to change minds, shape opinions, move others to act? The ability to influence is one of the essential skills for leaders at all levels for achieving effective management. It’s more art than science, and it can be tough to get your arms around. But the bottom line is that influence and persuasion skills matters. Whether you are leading, following, and/or collaborating, chances are you need to influence others to be successful. Influence strategies can range from reliance on position to education, encouragement and collaboration. The key is knowing which approach to use in a given situation. WHY SHOULD YOU ATTEND Almost everyone we come into contact with influences us in…
OVERVIEW No matter what business you are in, a dashboard is a critical tool in your communication armory and as with any communication tool, presentation is everything. Although there are many tools that can be used to create a dashboard, Excel business intelligence dashboard is commonly used due to its power, its flexibility and the fact that most people have Excel installed on their computer. This Advanced Excel Training focuses on what you need to know to create best Excel dashboards that are interactive and professional-looking. WHY SHOULD YOU ATTEND In this Excel dashboard training, you'll learn how to create a dashboard in Excel which is stunning, interactive and professional-looking. This training will provide you with a solid foundation th…
Overview This seminar will be addressing how practice/business managers or compliance officers need to get their HIPAA house in order, as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major 2019 changes taking place with the Health and Human Services regarding the enforcement of the HIPAA law as well as detailed discussions on the Phase 2 audit process and current events regarding HIPAA cases (both in courtrooms and from real-life Audits). Our instructor - Mr. Brian Tuttle has over 20 years of experience in working as Compliance auditor and has been an expert witness on multiple HIPAA cases. He`ll thoroughly explain on HOW and in WHAT scenarios patients can claim for cash remedies. More importantly, Brian will show you how t…
Overview: With the new HIPAA random audit program now getting under way, and increases in enforcement actions following breaches, now is the time to ensure your organization is in compliance with the regulations and meeting the e-mail and texting communication needs and desires of its providers and patients. You need the proper privacy protections for health information, and the necessary documented policies and procedures, as well as documentation of any actions taken pursuant to your policies and procedures. Your policies and procedures will probably need major revisions to maintain compliance in areas such as individual access of records, accounting of disclosures, and breach notification. And, of course, you will need to train your staff in all the new policies and procedures.…