6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020

Importing FDA regulated products requires careful planning before you even start.

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.

The logistics of importing products complicates the process further and you must know the consequences of your decisions. Some problems can cost you time and money, especially when you do not work promptly with the FDA. If you end up with having your entry “refused.” There is no appeal. Then you face the possibility of additional steep fines by CBP and be blocked from the U.S. market.

Why you should attend

Firms typically run aground with importing FDA regulated products because they do not understand how to prepare, conduct and report information in accord with FDA requirements. That mire of activity starts before you even ship a product to the U.S. If the exporter and importer do not follow the procedures or fail to submit correct information, the road forward has an expensive and time-consuming toll.

A failure to do things correctly will create a “bad actor” image, which is very hard to undo and FDA does not forget, somewhat like a regulatory elephant. It is true. If you understand FDA's and CBP's import program, your business can operate in a competitive way. If you do not, your customers, foreign suppliers, and stockholders will see the consequences and not be forgiving.

Who Will Benefit

  • Regulatory Affairs Directors
  • Software Designers / Specification Developers
  • Production Managers
  • Quality Assurance Directors
  • In-house Legal Counsel

Minimal Viable Product Workshop

ventureLAB Advisor, Paul Rivett, will explain how an MVP is the fast track to business growth and attracting investment.

What is an MVP anyway, who is it for, what does it need to do, and how can I get it built? Get answers to these questions in ventureLAB's MVP Workshop, and attend a 1-on-1 clinic to discuss your MVP.

ventureLAB Advisor, Paul Rivett, will explain how an MVP is the fast track to business growth and attracting investment. Additionally, he will speak on how to plan your MVP for speed to market and rapid adoption, which includes: Who an MVP is for and what it needs to do? Options for building/financing an MVP. Marketing your MVP. How to tell if your MVP launch is working.

Onboarding is NOT Orientation – How to Improve the New Employee Experience

In this webinar, we will learn the reasons onboarding is important today.

OVERVIEW

  • Understand why turnover is expensive
  • Learn when to connect with employees
  • Learn how to start the onboarding process before the start date
  • Learn the activities of orientation
  • Learn the activities of onboarding
  • Learn how the process works for different levels of employees

WHY SHOULD YOU ATTEND

Statistics show that half of all hourly employees leave the job within four months of hire and half of all salaried employees leave their jobs within 18 months. This turnover is expensive. Much of this turnover can be prevented by a proper onboarding process.

The Orientation, the process of making someone an employee, is no longer sufficient. When so much of a company's success is dependent on the intellectual property that employees produce it is critical to make sure that the employee is fitting in and succeeding. This is what a successful onboarding process accomplishes.

Those companies that do not do this successfully suffer lower productivity, potential loss of customers, and of course the eventual loss of the employee and the resultant replacement costs.

AREAS COVERED

  • The cost of turnover
  • The steps involved in onboarding
  • Before the hire
  • During the hire
  • The first day
  • The first week
  • The ongoing process
  • Special considerations for executives, nonexempt employees,and remote workers.

LEARNING OBJECTIVES

  • In this webinar, we will learn the reasons onboarding is important today.
  • We will learn that the terms orientation and onboarding are not interchangeable.
  • We will learn that orientation is in reality just one step in the onboarding process.
  • We will learn that the onboarding process begins before the hire is made.

WHO WILL BENEFIT

  • HR Managers
  • Office Managers
  • Supervisors
  • Managers
  • Company Owners
  • CEO
  • Employee Relations
  • Chief People Officer
  • Branch manager
  • Training Manager

SPEAKER

Years of Experience: 20+ years

Areas of Expertise: Human Resources

Michael D. Haberman is Vice-President and co-founder of Omega HR Solutions, Inc., a consulting and services company offering complete human resources solutions. Mike brings years of experience in dealing with the challenges of Human Resources in the 21st century. He helps companies work on compliance today to make them ready for the future tomorrow.

Mike is the author of the Human Resources blog found at OmegaHRsolutions.com, which has been recognized several times as a Top 25 in human resources related blogs. It has consistently been named as a top HR blog to read. He has been selected as one of six HR bloggers to be featured on the online version of Human Resources Executive Magazine. He has also been named in the Top 10 Digital Influencers in Human Resources and most recently has been named to the top 65 most influential HR pros on Twitter.

Mike has gained a reputation as a compliance expert. He speaks on a variety of subjects to business associations, human resource associations,and business based civic clubs. He has presented webinars on various HR related issues.

To Register (or) for more details please click on this below link:

http://bit.ly/30DG9Mb

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Data Integrity for the Laboratory and Beyond – Careful Considerations for Your Next Audit

In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.

OVERVIEW

Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.

To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in current Good Manufacturing Practices (CGMP) for US Food and Drug Administration (FDA)-regulated industry. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations.

The reasoning behind this complex issue is quite simple: if the integrity of laboratory data is compromised, batches of finished goods may not comply with regulatory authorization terms and, consequently, will not be released for sale.

WHY SHOULD YOU ATTEND

In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices.

These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Attendees will obtain an understanding of the regulatory expectations for data integrity compliance.

AREAS COVERED

  • Understand the current regulatory position on data integrity
  • Discover the criteria for data integrity
  • Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
  • Learn about approaches to data integrity risk assessment
  • Learn about approaches to improve data integrity in a laboratory environment

LEARNING OBJECTIVES

The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices for maintaining data integrity compliance.

WHO WILL BENEFIT

  • Site Quality Operations Managers
  • Quality Assurance personnel
  • Plant Managers and Supervisors
  • Manufacturing Superintendents and Managers
  • Regulatory Affairs Managers

SPEAKER

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet regulatory compliance.

To Register (or) for more details please click on this below link:

http://bit.ly/30ZhEt3 

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

I-9 Compliance-ICE is Stepping Up Its Compliance Audits. Are You Prepared?

What matters most to Immigration and Customs Enforcement (ICE) is whether the I-9 form is filled out correctly.

Topic : I-9 Compliance-ICE is Stepping Up Its Compliance Audits. Are You Prepared?

Register : https://www.compliancekey.us/webinarDetails?industryId=7&webinarid=1561&speakerid=232&source=SUT_LN

Discount Coupon : Use this Coupon (NEW2COMPLIANCE) and get (10% Off) On New Signup

Overview

The I-9 Form is often described as the most complicated 2-page form ever created. What makes an I-9 inspection especially maddening is it does not matter if all your employees are authorized to work in the USA. What matters most to Immigration and Customs Enforcement (ICE) is whether the I-9 form is filled out correctly.

Areas Covered in the Session :

  • The importance of understanding the requirements for completing I-9 Forms.
  • The importance of the timeliness of completing I-9 forms.
  • Determining best practices for Electronic Recordkeeping of I-9 Forms.
  • Developing a follow-up mechanism for temporary work authorizations.
  • The differences between E-Verify and I-9 record keeping requirements.
  • Fines and penalties for non-compliance
  • Conducting our own I-9 Audit

Speaker Profile :

Bob McKenzie is Keynote Speaker at ComplianceKey and He has over 40 years of human resources management experience. His background includes a wide range of hands-on HR practices including training and development, Equal Employment Opportunity, Affirmative Action Plan Development, development of compensation and incentive programs, performance management systems, recruitment, employee relations, union avoidance and labor contract negotiation. His working experience encompasses the manufacturing, banking, financial services, transportation, government, managed care, information technology and theme park industries.

Contact Info :

Compliance Key

https://www.compliancekey.us/

Email : support@compliancekey.us

Phone : +1 717-208-8666

Effective Communication Strategies: Using DISC as Your Powerful Leadership Guide

This course is designed to provide you with an enlightening overview of the DISC behavioral assessment that measures individuals’ natural, hard-wired behavioral style.

OVERVIEW

This course is designed to provide you with an enlightening overview of the DISC behavioral assessment that measures individuals’ natural, hard-wired behavioral style. This style remains quite stable over our adult lifetime. As such, the hard-wired DISC style provides the most accurate starting point for self-awareness, individual development, and guided success attainment.

If an assessment tool does not measure it, the starting point for development is obviously misguided.

WHY SHOULD YOU ATTEND

As an individual identifies their DISC results, they are empowered with very practical and specific information to guide behavioral modification.

The DISC model has four main behavioral styles, also known as DISC profile types or DISC styles:

  • D-style (Dominance)
  • I-style (Influence)
  • S-style (Steadiness)
  • C-style (Correctness)

All of us are a combination of all four DISC profile types and it’s important to understand the different types for communication success.

AREAS COVERED

  • DISC behavioral assessment: what it is and is not
  • DISC map and its 2 primary spectrums for understanding human behavior
  • 4 main DISC profile types and their attributes, behavior under pressure, behavior in fear, and DISC communication styles
  • OAR method to identify the styles in others
  • Quick and easy-to-spot identifying behaviors
  • Practical guidelines for modifying your hard-wired behaviors to formulate effective communication strategies and attain success in communication and professional relationships

LEARNING OBJECTIVES

Your success in life – both professional and personal – is determined in large part by how well you interact with others. Your ability to effectively relate, communicate, influence and motivate others is a crucial skill in creating successful relationships with customers, prospects, colleagues, subordinates, managers, friends and family members.

You have probably noticed it is very easy to get along with certain people. You almost instantly and effortlessly understand the other person. Unfortunately, with most people communication takes more effort. It does not flow easily. You cannot quite understand where the other person is coming from, what they really want, and what their intentions are.

In this course, you’ll learn a system for understanding human behaviors that is simple to learn and simple to use. You’ll learn how you are and how others perceive you. You’ll also be able to pick up specific features from others so that you can better understand them. And, most productively, you’ll learn about DISC communication styles and how to adjust your style to achieve your goals.

WHO WILL BENEFIT

  • Leaders of companies, departments, and work groups
  • Training and development professionals
  • Executive coaches
  • Leadership and communication practitioners
  • Human resources professionals – all levels
  • Team leaders and project leaders
  • Change management professionals
  • Anyone who wants to improve their communication skills and interpersonal relationship skills

SPEAKER

Melveen Stevenson is the CEO and founder of M.S.Elemental, LLC, a human resources and business advisory firm based in Los Angeles, California. As a certified HR professional with a background in accounting and finance, she helps companies to navigate the human resources “jungle” of compliance, human capital, and leadership challenges. By using an encompassing business approach, she helps to strengthen the infrastructure of organizations from the inside out, specifically through leadership development, operations, training, employee engagement, and career coaching.

To Register (or) for more details please click on this below link:

http://bit.ly/37lov2g

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

How to Achieve Flawless Execution: Driving Results with Effective Leadership

This webinar will show you how to achieve flawless execution without sacrificing people or human dignity.

OVERVIEW

Flawless execution is the ultimate practical behavior that the most successful companies strive to attain. The stories about Steve Jobs demanding perfection at Apple are legion.

The quality and design excellence of Apple products is also common knowledge. This webinar will show you how to achieve flawless execution without sacrificing people or human dignity.

WHY SHOULD YOU ATTEND

Errors, mistakes and oversights are some of the most expensive problems in business today. It doesn’t have to be a big problem if you commit to striving for flawless execution. Quality execution is not easy to attain but it is within reach if you make a serious commitment, apply lots of passion and of course, a plan.

Flawless execution is one of the most classic examples of where the energy, drive and vision have to come from the top and filter down through the organization. Quality will not stand a chance without highly dedicated leadership.

When the rank and file people within an organization get a vision of quality, excellence and they taste the thrill of achieving what is possible, they become super dedicated to progress.

On the other hand, when the leadership within the organization is not able to emotionally or behaviorally continue to set the example of excellence, the best qualified and highest achievers will leave the organization.

Excellence will only thrive where leadership sets a positive, progressive and profitable example.

AREAS COVERED

  • What is flawless execution?
  • How do you design a plan that is realistic?
  • What about the emotions and culture?
  • Next comes the behavior patterns
  • Practical mechanics that work with real people
  • Getting and appreciating the right people
  • How to build productivity through rewards and recognition
  • Focus on feedback and followup
  • Master the art of effective communication
  • Become aware of, notice and reward positive & productive behaviors

LEARNING OBJECTIVES

Learn what is flawless execution and how to achieve it. Discover the secret to high achievement at a truly REMARKABLE level.

WHO WILL BENEFIT

  • CEO, CFO, COO, etc.
  • Vice Presidents
  • Managers
  • Those being groomed for promotion.

SPEAKER

David Rohlander's passion is helping executives create a masterpiece personally and professionally. That's why he wrote, “The CEO Code,” a Best Seller on AMAZON. That success resulted in Penguin/Alpha Books asking David to write “IDIOT'S GUIDES: Management Skills” released in December 2014.

To Register (or) for more details please click on this below link:

http://bit.ly/2Ro7QFN

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

6-Hour Virtual Seminar on Project Management for Non-Project Managers

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution.

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Why you should attend

It is not possible to present a complete treatment of project management in the span of 6-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of any project. Without basic tools, it is not possible to effectively manage a project to the pre-determined end-date without turmoil and chaos.

We have distilled the key aspects of project management into three two-hour virtual seminar segments that will logically move participants from the beginning of the project management process to the end – from initiating the project to closing the project.

The seminar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments.

Who Will Benefit

  • Any member of a Cross Functional Project Team that has the Potential Opportunity to Lead that Project
  • Engineers
  • Marketing Associates
  • Product Managers
  • Program Managers
  • Contract Managers
  • Project Managers
  • Research & Development Associates, Managers, and Directors
  • Design Engineers
  • Manufacturing Managers

6-Hour Virtual Seminar on Harassment in the Workplace: Effectively Dealing with Harassment and Its Relationship to Discrimination, Retaliation, and Hostile Work Environments

Retaliation claims are costly and time-consuming for employers. Missteps in handling sensitive employee issues could result in the organization writing a check with a lot of zeros.

When an employer receives an allegation of workplace harassment, taking prompt and appropriate action is the employer's legal responsibility. It is imperative that employers understand how to recognize harassment, evaluate the scope of their internal investigations, document steps taken along the way, and insulate their organization from subsequent lawsuits.
Additionally, it's also important for employers to ensure all parties are treated fairly during the process and be sensitive to how the organization's process is communicated and implemented.

In any case of workplace harassment, an employer's behavior must meet a certain standard in the eyes of the law. Just posting an anti-harassment policy, while a positive step, is insufficient to prove that an employer took workplace harassment seriously.

Workplace harassment isn't limited to sexual harassment and doesn't preclude harassment between two people of the same gender. The harasser can be a boss, a supervisor in another department, a co-worker, or even a nonemployee. The victim doesn't necessarily have to be the person being harassed; it can be anyone affected by the harassing behavior.

Harassment can also be considered a form of employment discrimination under various federal, state and local laws. In order to be considered discrimination, the harassment must be based on some protected trait. Under federal law, those traits include race, color, national origin, gender, pregnancy, age, religion, disability, and genetic information. Many state and local governments have enacted similar anti-discrimination laws.
Retaliation claims are costly and time-consuming for employers. Missteps in handling sensitive employee issues could result in the organization writing a check with a lot of zeros.

6-Hour Virtual Seminar on FDA’s Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use

Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.

The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction. The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern. Part of that risk involves the intentional activity that can conflict, intrude or destroy software. The problems are taking center stage in the “healthcare software” dialogue.

What issues can compromise or defeat the functional use of your software? Poor cybersecurity programs, lack of interoperability with third-party software, the wave of unmanageable apps and wireless home use technology. Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.

Why you should attend

  • FDA's changing regulatory controls
  • Cybersecurity management by design, oversight and preventive action
  • Ransomware attacks and recovery
  • Use voluntary standards and NIST
  • Mobile apps regulated and those not regulated
  • Wireless/home use software systems and human factors

Who Will Benefit

  • Business Planning Executives
  • Regulatory Directors
  • Software design and specification developers
  • Real time software performance auditors
  • Recall managers
  • In-house Legal Counsel
  • Customer support and service directors
  • Contract Specialists
  • Business acquisition Managers
  • Hospital Risk Managers