Transition from Peer to Supervisor

A promotion is certainly something that every employee looks forward to. In most cases, it is a just reward for all the hard work, initiative, dedication and motivation an employee exhibits at work. Yet, most employees what are promoted fail to reckon with a very problematic situation that a promotion brings: having to work with the very colleagues the employee superseded and got promoted.

This can be quite an issue, because, after all, it is human nature to be insecure, envious and even cantankerous about a peer’s progress, even if it was well-deserved. Having to deal with such colleagues requires tact, amiability, understanding and openness.

Tonia Morris, Founder of Simply HR, LLC a consultant and management firm, will show what qualities to cultivate and demonstrate in such situations at a four-hour webinar that is being organized on January 10, 2020 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance.

At this webinar, which is of immense value to Managers, Supervisors, Leaders, Human Resource Professionals, and Shift leaders or Team; Tonia will get down to explaining ways by which supervisors can lead from the front without getting into conflict with their colleagues, especially those whose position they would have taken, or those who they would have outperformed.

Please visit Globalcompliancepanel to register for this valuable learning.

 

This webinar will offer newly promoted employees the tools and techniques for dealing with their colleagues. It is vital for them to have this knowledge because lack of it can result in frictions at work. As conflict deepens, there are chances of many employees quitting the organization and looking for better options. The learning gained at this webinar will help the participants foster better employee engagement, a core factor in retaining talent and increasing productivity.

The result of this learning is that the newly promoted supervisor will be better equipped to handle discordance at work. Tonia will show how to motivate direct reportees and handle conflict while remaining legally compliant all the time. The skills learnt at this webinar can be applied straightaway at work.

This webinar will have the following agenda:

• Setting Yourself up for Success
• Developing Legal Awareness
• Understanding Communication Styles
• How to Build Trust
• Motivating your Team to achieve results
• Delegating Work to Your Team
• Managing Employee Performance
• Time Management
• How to deal with uncomfortable situations

 

About the speaker:

Tonia Morris, who calls herself “your Generational Connector”, owns her speaking and training company. An accomplished speaker, Tonia offers leaders training solutions that cultivate a generationally-inclusive work place.

She has partnered with organizations such as Chick-fil-A, Oracle, Spelman and Kennesaw University to name a few, to bring training solutions for engaging Millennials in the workplace, working with leaders to transform their cultures by attracting, developing and retaining a workforce that is generationally inclusive.

With more than 20+ years of progressive HR experience, Tonia provides keynote speeches, lunch-and-learns, and workshops for organizations and associations across the Southeast.

 

 

Screen-free coding for kids : mTiny robot review

My five- and seven-year-old constantly fight over who gets the iPad first. We have one, and they get to use it in tiny doses, usually when I’m at my wit’s end. Their favorite app? ScratchJr, MIT’s go-to coding tool for kids. They like to code. No. They love to code, like the good little 21st-century humanoids they are.

They love coding so much and I am so unwilling to give them their own devices that I decided to try something new. It’s also something that sounds so counterintuitive it actually might work: screen-free coding.

With the latest studies presenting a pretty damning picture of screen time’s effects on children’s development, I’m delighted to hear that screen-free coding is all the rage now. It is exactly what it sounds like: a way to explore the key concepts of coding sans screen. At its core, coding is simply giving a set of specific directions to someone or something to produce a desired result. Nothing in that definition demands a screen.

It is about computational thinking though and the ability to identify and solve problems by breaking the problem and solution into workable chunks. You could teach your kid computational-thinking strategies by asking them to tell you how to make a peanut butter sandwich and it meets the screen-free requirement.

While my kids may want to consume peanut butter sandwiches while they code, hearing that they’re “coding” by telling me how to make them wouldn’t go over well. They want to turn ScratchJr purple and make him curse and jump. They want some form of pixels and plastic to beep and whir and zing. They do not want to watch their mother botch sandwich making because of their bad directions.

Enter mTiny, Makeblock’s cube-shaped robot for the preschool set. It’s cute. It’s fun. It talks. It twirls and giggles and sings. It’s screen-free but uses the same graphics found in ScratchJr in the form of coded cards.

In addition to the USB-rechargeable mTiny robot — with cute panda ears and tail — the kit comes with 36 coding-instruction cards, which are essentially cardboard versions of the ScratchJr graphics. To build codable scenes for mTiny to navigate, Makeblock includes 24 themed, reversible map blocks that kids put together like jigsaw pieces.

More read via https://www.engadget.com/2019/11/17/mtiny-screen-free-coding-robot-review-stem-toy/

How Artificial Intelligence is transforming logistics sector

The Logistics sector has always been one of the most growing sectors and a laggard in the adoption of technology. But the advent of latest technologies like IoT, Artificial Intelligence (AI), and Machine Learning (ML) have set this sector on a path, which is soon going to not just transform the sector but also will give rise to a whole new breed of paradigms. Now, as the demand for logistics companies is growing, the driver’s safety has become a primary concern.

With the apps like fleet management system (FMS), it is possible to observe driver’s behaviour in real-time and make a training plan which can also solve the issue of employee’s long driving hours and breaks between drives with fully automated fleets. The availability of sensors and Bluetooth wireless technologies in the trucks have made it easier to add trucks to this burgeoning online network of supply chain data, providing last-mile visibility that was previously unattainable.

Logistics companies are using GPS systems and AI to track the location of their trucks, they can now set up geofences to enable alerts when a truck is nearing its destination, danger, optimise routes using real-time traffic data, improve vehicle utilisation, and automatically track driver hours and fuel tax reporting information. A user-generated input via smartphones is sent onto the drivers which helps them to know the route around construction or congested areas. So that they can avoid these routes and take an alternative route.

Firms have started using this technology for Fuel optimisation, Operational Planning & allocation based on Geospatial & status data, dynamic route management and control. In situations like human errors, traffic or accidents, AI predicts decisions based on data analysis and help to avoid accidents and maintain their safety.

Full Post you can read Via https://www.financialexpress.com/industry/technology/how-artificial-intelligence-is-transforming-logistics-sector/1765595/

2 Day Seminar on “Death by CAPA – Does your CAPA Program need a CAPA?” – GlobalCompliancePanel

If there is a really solid edifice on which a strong Quality Management System (QMS) rests, it has to be Corrective and Preventive Action (CAPA). This is because a QMS can never guarantee safe and effective products without CAPA. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters.

An inefficiently conceived and implemented CAPA system means time and resources going down the drain. The criticality that CAPA has to a QMS can be gauged from the fact that it is one of the primary reasons for which the FDA issues 483’s and Warning Letters.

All these point to the need for the establishment of a solid CAPA process that is built into the QMS. An organization should ensure that it establishes a compliant, effective, and efficient process. Yet, despite the all-powerful importance that CAPA has for the medical device industry, many manufacturers in this area have difficulties in establishing and maintaining an effective CAPA process.

How do organizations overcome this problem? A two-day seminar, entitled “Death by CAPA – Does your CAPA Program need a CAPA?” from GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, will provide the answers. At this in person, live seminar, which is being organized in Philadelphia, PA on October 24 and 25, Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., will be the Director.

Please join us for this highly valuable session by enrolling at This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

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The learning offered at this seminar will help participants establish an efficient and effective CAPA process that leads to an improvement in quality and compliance. Participants will learn the ways of streamlining and monitoring their processes that will ensure compliance and improved performance.

Susanne will explain the regulatory requirements regarding CAPA in detail. She will sort out the various myths surrounding CAPA, as well as the challenges of managing CAPAs. This knowledge will help them prevent and overcome common problems and pitfalls. She will offer an explanation of some of the best practices in establishing a CAPA, the knowledge of which helps organizations insulate themselves against an FDA inspection.

Over the two days of this seminar, participants will hear detailed lectures on all the elements of a CAPA program. Susanne will explain the ways in which these elements connect to other parts of the organization’s Quality Management System. The Director will explain to participants ways by which they can create a CAPA program that results in:

• Improvement in product quality
• Reduction in compliance issues
• Advancement in their business success.

An additional benefit the participants will get is the set of tools and checklists which will help them to ensure that their program is ready to face an FDA inspection.

Susanne will cover the following areas at this seminar:

• Regulatory Requirements and expectations
• Elements for creating an efficient and effective CAPA Program
• CAPA process, tools, and techniques
• Linkages throughout the Quality Management System
• Root Cause Analysis
• Metrics, Control, and Monitoring
• Dissemination of Information
• Myths, Challenges, Best Practices
• Inspection Preparedness

This seminar is of immense value to professionals whose work is associated with the organization’s QMS. These include Quality Systems Specialists, Document Control Specialists, Quality and Compliance Specialists, Quality Engineers, Internal Auditors and Managers, Training Specialists, CAPA Specialists, CAPA Managers, Supplier Quality Engineers and Auditors, Quality/Compliance managers or directors for Medical Device companies, General Managers wanting to learn how to understand Quality System requirements, and Management Representatives.

The EU Clinical Trial Regulation – EU Filings & Registrations

The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].

This course also covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

Attendees will leave the Course clearly understanding the requirements under the current Regulations. In addition, this Course has been updated to provide participants with competitive insight into:

• How the EU and individual countries within Europe interact
• Which registration procedure to use
• How regulations effect product development strategies
• Understanding the concerns/issues of European Regulatory Personnel
• How to negotiate with the regulators
• Information necessary for effective submissions
• Strategies for streamlining the registration application process for faster approval
• The advantages and disadvantages of various registration procedures
• How to efficiently initiate trials first patient, first visit
• How to link the strategy of Country Selection to an ultimate EU registration pathway
• How to stay compliant What can make the difference in your data passing Regulatory scrutiny
• Related area-GCP and PV-reporting updates
• Impending Changes of the EU Clinical Trial Regulation and timing for Implementation

Who will get the benefit:

• Business Management
• Project Team Members
• Legal Team Members
• Clinical Operations Staff
• Quality Assurance, Monitors, CRAs
• Regulatory Affairs
• Investigators & Site Study Staff
• CROs, Consultants, Insurers

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Easy Ways You Can Turn Hipaa Compliant Into Success

The first presentation explains the history of HIPAA, why it came into being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is.  It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates.

The second part of the first presentation is an overview of how to manage the HIPAA compliance project.

The second session describes what a Risk Assessment is and how to perform the risk assessment. The materials take the participant through the factors of HIPAA compliance and how to perform a HIPAA Risk Assessment. This encompasses taking the participants through how to do a HIPAA Privacy Risk Assessment, how to do a HIPAA Security Assessment and how to interpret the results, set priorities and develop a plan for addressing the Risk Assessment findings.

The third session takes the participants through how to prepare a set of HIPAA Policies and Procedures. This includes how to reference the HIPAA regulations in preparing the policies and procedures, how to reference the prior HIPAA Risk Assessments and how to prepare the HIPAA training materials.

The fourth session provides the participants with an orientation of the role the IT services in the healthcare organization in addressing the organization’s HIPAA compliance. This encompasses understanding what role IT hardware and software plays in the HIPAA compliance process, what responsibilities IT vendors should have and how to work with vendors. The materials will discuss IT security in the context of an overall organization security program including the value and approach of an IT security vulnerability test.

 

In the last session participants will review what a HIPAA breach is and what to do when a HIPAA breach occurs. This includes determining if a notification occurred, notification requirements and mitigation options.

There will be a wrap up and discussion session providing an opportunity for the participants to discuss specific issues they may have or get direction regarding particular approaches for HIPAA compliance.

The need for HIPAA compliance has evolved since the HIPAA laws were passed in 1996. In addition, as technology has advanced into more use of the internet and web-based hardware and software resources, compliance has also become more difficult and complex.

Now both covered entities (providers of health care services) and their business associates (support vendors) have to implement comparable compliance measures.

Breaches are almost impossible to escape – recent studies show that approximately 90% of covered entities and business associates have had at least one breach of a patient’s protected health information.  And, HIPAA federal penalties can be significant.

Compounding the issue is that almost all states have incorporated the HIPAA regulations, in one form or another, into their state health care privacy laws and/or the courts have accepted the HIPAA regulations as the standard of care for protecting a patient’s health information.

It is important for the health care organization to know what is expected by the regulations.

To satisfy your HIPAA compliance requirements, health care management and staff need to understand the HIPAA privacy and security regulations, understand how to assess your health care organization’s HIPAA compliance status, understand the role of each of the members of your workforce in meeting your compliance requirements and know what to do if there is a breach of your patient health data.

This webinar provides an in-depth review of these subjects and leaves the participant with a solid understanding of what has to be done to be HIPAA compliant.

People who will be benefits from this

• Health Care Organization Ownership and Senior Management
• Office Management
• Business Associates
• Physicians
• Ancillary Service Organizations (Pharmacies, Labs, Radiology)
• HIPAA Compliance Professions
• Health Care System Vendors

Directives on active implantable medical devices (90/385/EEC)

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.

This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.

• The updated Regulation
• Implementation dates and transition
• Main changes and products affected
• Effect on medical device manufacturers

Salma Michor , PhD, MSc, MBA, CMgr, RAC is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.

eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD – Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Reformatting for multiple submissions is substantially limited.  The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.  Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

Those who are benefited by this

• Regulatory Affairs
• Quality Assurance
• Pharmacovigilance
• Project Management
• Regulatory Operations
• Anyone responsible for providing content for the CTD

Instructor:

Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014).

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

To compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

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.

GLPs are enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

• What are Good Laboratory Practices
• Why were they created
• What is the objective of GLPs and how are they associated with GMPs and SOPs
• Statistical procedures for data evaluation
• Instrumentation validation
• Analytical and laboratory certification
• Documentation and maintenance of records
• Consequences of noncompliance
• Disqualification and reinstatement

Who will be benefited by this

• Quality Assurance Personnel
• Quality Control Personnel
• Research and Development Personnel
• Regulatory Affairs Personnel
• Project Managers
• Manufacturing Managers
• Validation Engineers
• Internal Auditing Personnel
• Microbiology Personnel
• Auditors

Instructor Joy McElroy With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

Upcoming Changes with HIPAA 2019

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.

It will also address major changes under the Omnibus Rule and any other applicable updates for 2018.

Do you know all of the requirements of this enigmatic law? Are you abiding by them?

My goal is to make this extremely complex enigma known as “HIPAA” very easy to understand with a painless step by step approach to an otherwise harrowing task Times have changed and new laws are now in place concerning protected health information.

The best way to protect your practice or business and save yourself future headaches and possible litigation or Federal fines is to be proactive instead of reactive This once rarely enforced law has changed and you need to know what’s going on! Protect your practice or business!

These day’s trial attorney’s pose an even higher risk than the Federal government!

State laws are now in place increasing liability for patient remedies!

What factors might spurn a lawsuit or a HIPAA audit? are you doing these things?

We will be discussing 2019 changes taking place in Washington with the Health and Human Services regarding the enforcement of the HIPAA laws already on the books as well as some detailed discussions on the audit process and some current events regarding HIPAA cases (both in courtrooms and from live audits)

Instructor cover all these areas:

• Study all 18 Standards and 44 Implementation Specifications of the regulations
• Updates for 2019
• Requirements of Compliance Officers
• New definition of what constitutes protected health information
• Real life litigated cases
• BYOD
• Portable devices
• Business associates and the increased burden
• Emailing of PHI
• Texting of PHI
• Federal Audit Process
• HIPAA and suing – how this works
• Risk Assessment
• Best resources