Project management critical tasks within each project phase

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 be benefit by this:

• 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

About the Inructor:

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

The Next Few Things To Immediately Do About Hipaa Training for Compliance Officer

This 6-hour seminar 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.

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 and don’ts with HIPAA -I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors.

We will go through multiple scenarios that are commonly faced by compliance officers and how to manage these situations
I will also speak to real life litigated cases I have worked where HIPAA is being used to justify state cases of negligence -THIS IS BECOMING A HUGE RISK!

In addition, this course will cover the highest risk factors for being sued as well as being audited (these two items tend to go hand in hand).

Why you need to know 

Do you have an affective HIPAA compliance program?  Do you know what needs to be done to satisfy the requirements?
New laws, funding, and enforcement mean increased risk for both business associates and covered entities – 2017 was a record year for enforcement and fines – 2018 will be no different.

HIPAA Omnibus – Do you know what’s involved and what you need to do?

What does Omnibus mean for covered entities and business associates?

Why should you be concerned?

Court cases that are changing the landscape of HIPAA and patient’s ability to sue!

TRIAL ATTORNEYS ARE MORE DANGEROUS THAN THE FEDERAL GOVERNMENT!!

It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates.  You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT or internal administrative practices.

About the Intructor 

Brian L Tuttle, CPHIT, CHP, CBRA, Net+, A+, CCNA, MCP is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 15 years’ experience in Health IT and Compliance Consulting. Mr. Tuttle has worked all of those 15 years with MAG Mutual Healthcare Solutions and is now Senior Compliance Consultant and IT Manager with InGauge Healthcare Solutions (previously named MAG Mutual Healthcare Solutions). Almost all of Brian’s clients are earned by referral with little or no advertising. Brian is well known and highly regarded in medical circles throughout the United States .

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Medical Device Recalls: How to Properly, Compliantly and Promptly Deal with a Recall

The Federal Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to order recalls of medical devices, under certain circumstances (e.g., situations involving serious and immediate hazards to health) and controls.  With very few exceptions, device recalls by companies are voluntary.

There are three regulations promulgated by FDA that define their authority and the requirements applicable to device manufacturers and importers for the correction or removal-collectively known as recall-of medical devices; the requirements for these regulations are outlined in 21 CFR §7, 21 CFR §806, and 21 CFR §810. Each of these regulations is presented in detail in the following pages. Compliance with these three regulations also touches upon other regulations administered by FDA.

Failure to properly report events and take corrective and removal actions can cause costly problems for a manufacturer and can be life threating for consumer. The number of device companies having their recall classified as a Class 1 (most severe) has surged in the past three years.  We will take the time to interact though the day to navigate all aspect of the recall process

This course will provide understanding recall compliance and the interrelationship on Complaint Handling, CAPA, and Risk Management processes. It will be beneficial to all device manufacturers and is recommended for any individuals or teams that are involved in post marketing of medical devices.

Join Rita Hoffman, RAC an expert in the field of Post-Market Compliance.  Not only will you learn from her over her 40 years in both FDA as a Compliance Officer and Ombudsman, learning from her stories of what not to do, but you will take back a desktop manual on Post-Market reference guide.

Areas covered by the Instructor:

Determine what actions are taken in a medical device recall

• Cite the regulatory requirements for recalls/ field actions regarding medical devices
• Reference and use medical device recall authority and guidance documents
• Identify and understand the applicable regulatory standards and guidance documents
• Identify the different recall types and classifications
• Explain what types of communications are required
• Define what effectiveness checks are
• Outline the steps required to terminate a recall and what regulatory reports and records are required for a device recall
• Understand how to comply with complicated Compliant Handling, MDR and Recall requirements
• Firms MDR reporting and FDA’s handling of MDR reports
• Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
• Minimize your risk of regulatory enforcement actions
• Understand the relationship and interaction with other quality system elements as they relate to complaints and reportable events
• Walk-through of case examples
• Discussion of FDA’s New Guidance’s on Risk and how it interacts with Recalls

IMPORTANCE OF BUSINESS INTELLIGENCE FOR INDUSTRIAL PROFITABILITY

The assembling business is one of the most tangled and requesting parts in light of the eccentrics of creation and tasks. Various associations attempt to unravel the systems to restrict the costs and addition the benefits. This in like manner fuses lessening the exercise in futility, endeavors, and stock. Thusly, it has ended up being basic to use information investigation and enormous information to be more information driven. This strategy outfits you with bits of knowledge into your system and strategies for better basic leadership and basic reasoning.

According to an ongoing Gartner examine, 80% of makers simply measure results. They measure past execution by investigating the results in the spending rundowns. To be sure, even the most relentless Lean Manufacturing Six Sigma Theory of Constraint specialists don’t have the foggiest thought what affected these results, or what is best done to improve proceeding.

On numerous occasions assembling firms, even top-level activities chiefs, use association investigations or reports which negligence to ask regarding why results failed. There is a thought to all elements consistently and also rather than seeing which region of a mechanical business needs most astuteness with respect to improving advantage.

Current industry examples exhibit that reception of Business Intelligence (BI) in organizations is on the rising with the more broad availability of BI programming just as the improvement of bleeding edge answers for handle enormous information. Various business methods are currently getting the opportunity to be mechanized, for instance, sending pamphlets to customers, making consistently deals reports, and amassing web based life experiences. In this manner, benefit and profitability are expanded, allowing SMEs to get a firmer solid footing in the market.

The assembling business is consistently changing a direct result of innovative improvements. Associations are searching for ways to deal with get an aggressive edge against their overall opponents. Information situated frameworks are supplanting the traditional ones. As associations are going up against a regularly expanding number of troubles, the enthusiasm for clear, information driven bits of knowledge is more unmistakable than whenever in late memory.

Assembling organizations are very information escalated in any case, consistently they are not prepared to use the data sagaciously. Gigantic piles of data falsehood inert with the associations. Business insight supports the capacity of these associations to use the assembled information in a productive way. BI can modify critical thinking and basic leadership. All of the territories of assembling gets changed in a beneficial way when BI steers.

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Virtual Seminar on Upcoming Changes with HIPAA 2019

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.

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)

What are areas covered by the Instructor:

• 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

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Want An Easy Fix For Your Good Laboratory Practices? Read This!

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 the Learning Objectives:

• 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 Benefit:

• 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

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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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