Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

Learn more on this topic by visiting : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900774SEMINAR?linkedin-SEO

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is prescriptive and hierarchical, and well-defined. Although all these processes can be put in place for only one function; it makes better business and economic sense to have a management system that performs and carries out its objectives across a spectrum of functions and activities.

Organizations should ideally build a comprehensive and thorough management system that should be a set of standards and practices that addresses the organization’s safety, health and environment management aspects. A major advantage having such a system brings is that it makes the entire process efficient, consistent, cost effective and timely.

Creating a fulcrum for health and environment management systems

An effective and proven way of making management systems work effectively is for corporations to use the business asset to set and create inputs for the various standards around the functions. The standards and practices that are put in place in such a manner become the basis and edifice on which decisions relative to resources and dollars spent within the Safety, Health & Environment (SH&E) scope of business are made. In other words, a management system works best and most effectively when it becomes a pivot around which a host of functions can be performed.

Safety, health and environment are the core issues of a sound management system. If organizations have to build an SH&E system that is designed along the lines described above; they need to have the ability to properly assess their requirements first. They need to also have the foresight to anticipate the changes that these functions will undergo in the future, and should build a management system that has the robustness, flexibility and resilience to accommodate and ingest these changes. The financial consequences of building a management system that fails to take these factors into consideration are huge.

A management system that takes SH&E into consideration can achieve a lot

This process accomplishes the following:

o  Identifies the things that need to be managed within the function

o  Constructs a process, tool, or mechanism that best manages each of those things identified. They are usually a set of standards, practices and programs that are built specifically for a particular function

o  Builds the standard, practice or program so that it can be adjusted according to results

o  Builds a measuring metric, benchmark or scorecard with both lagging and leading indicators

o  Builds the management system in a way that is hierarchal in structure within the organization – (corporate sets and standards and the business unit builds the practice around the standard)

Trainings for inculcating the mindset for building a strong management system

The principles to adapt and the thinking needed to cultivate the outlook for building such a management system will be the core part of a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas.

James J. Thatcher, President and Owner, Global Safety Solutions LLC., who is listed as an expert witness for operational as well as safety, health, environmental, training and security issues in the Oil and Gas industry and the mining, minerals and chemical industry; will be the Director at this learning session. Please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900842SEMINAR?wordpress_SEO    to register for this highly valuable learning session.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

In-depth exploration of SH&E management systems

This seminar will make an in-depth exploration of management systems in the health and environmental areas. James will offer a detailed understanding of SH&E, plus Training and Security (TS), which are the functions around which standards and practices are built. He will describe the 16 functions that cover the SHE & TS world in detail, which will help participants understand ways by which to build a standard and practice around all these 16 functions.

The 16 functions that will have a standard and practice specific to the function are:

o  Hazard identification & control

o  Occupational health & industrial hygiene

o  Incident management

o  Emergency preparedness

o  Environmental

o  Regulatory compliance

o  Reporting performance

o  Managing risk

o  Managing safety

o  Management security

o  Verification & audits

o  Document & record management

o  Contractor & service provider management

o  Competency management (training)

o  Commitment, communication and implementation

o  Managing change

The Director of this seminar will also explain the role of supporting documents, associated programs, procedures or Standard Operating Procedures (SOP) that are a part of the particular function being managed, to enable clear understanding of the topics.

HIPAA survival needs intimate knowledge of the nuances of the law

HIPAA survival is one of the great challenges for a healthcare entity. HIPAA audits are complex, and they need understanding of the jargon and the semantics of the words mentioned in the document to survive. Both the Covered Entity and the Business Associate need to know exactly what to do in order to pass a HIPAA audit. This is all the more important and necessary considering that the federal budget has plans of raising the budget for the OCR in 2017 by about 10% over 2016, reflecting just how serious the OCR is about HIPAA audits.

When one considers that Phase 2 of HIPAA requires compliance with something like 180 areas and allows just 10 days for response; it goes without saying that HIPAA survival is a high priority for Covered Entities and their Business Associates. Moreover, the OCR’s audit protocol clearly states that those entities that are being audited have to furnish the exact documents required and not offer broad references to policy documents.

Being even slightly lax in being prepared for Phase 2 HIPAA audits can lead to difficulties at the audit. So, HIPAA survival entails having to be one’s toes all the time and having all the edges covered and leaving nothing to chance. HIPAA survival is about putting a process in place and overseeing and implementing it with utmost diligence and attentiveness all the time.

Covered Entities and Business Associates are the target of HIPAA audits

So, where do all these place Covered Entities and Business Associates that are the target of HIPAA audits? There is simply no room for complacence. They have to be absolutely on their guard when facing HIPAA audits. HIPAA survival has to be cultivated as a means for this. The more they hard-wire the art of HIPAA survival into their practice, the better.

The ways by which Covered Entities and Business Associates deal with HIPAA survival is the subject of a two-day seminar that GlobalCompliancePanel, a highly popular provider of professional trainings for the areas of regulatory compliance, will be organizing. To enroll for this highly useful and important session on HIPAA survival, jus log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900780SEMINAR?HIPAA-survival-Chicago-IL.

At this seminar, Brian L Tuttle, a senior Compliance Consultant & IT Manager at InGauge Healthcare Solutions, will educate regulatory compliance professionals about how practice managers need to prepare for HIPAA audits. This seminar will address major changes under the Omnibus Rule and any other applicable updates for 2017. Brian will also cover other related, critical areas such as:

o  Texting

o  Email

o  Encryption

o  Medical messaging

o  Voice data, and

o  Risk factors as they relate to IT.

Brian will dispel many of the myths covering this convoluted law. He will discuss the do’s and don’ts of HIPAA survival, and will also cover the critical area of the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures.

During the course of this seminar, Brian will cover the following areas:

o  History of HIPAA

o  HITECH

o  HIPAA Omnibus Rule

o  How to perform a HIPAA Security Risk Assessment

o  What is involved in a Federal audit and how is it conducted

o  Risk factors for a federal audit

o  EHR and HIPAA

o  Business Continuity/Disaster Recovery Planning

o  Business Associates and HIPAA

o  In depth discussions on IT down to the nuts and bolts

o  BYOD

o  Risk factors that can cause an audit (low hanging fruit)

o  New rules which grant states ability to sue citing HIPAA on behalf of a patient

o  New funding measures

https://www.onr.com/blog/hipaa-audits-increase-2016-2017/

Assessment-based prediction is an effective tool for hiring the right candidate

Undoubtedly, hiring should rate as being among the most important activities for an organization. This is so because it is through this process that the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up their mind by asking critical questions with which to make predictions about a potential hire. These questions could relate to how well the resource can perform in the assigned role, for how long the resource could stay in the organization, and making an assessment about the person’s ability to handle more responsibilities.

Not all HR and other hiring managers could be right all the time in predicting the outcomes of their actions about a candidate; yet, a good understanding of principles of assessing the candidate, combined with proper preparation and inculcation of a little disciple will go a long way in helping them become more accurate in their predictions. When the hiring managers are not too way off their mark in predicting the attributes of a useful hire, they are more likely to get a better candidate and avoid much of the unpleasantness that a bad hire can cause.

Learn the art of predicting the usefulness and relevance of a candidate

It is to equip participants with the tools needed to design a process for selecting and promoting for any position across any industry that a two-day, in person seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Harry Brull, who is President, Laurdan Associates, Inc. and Co-Founder of BCG Consulting Group, will be this seminar’s Director.

professionaltraining

To get an understanding of how to get the right insight into a selection process that is relatively error-free and effective, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900717SEMINAR to register.

Insights into getting the hiring and promoting process right

At this seminar, Harry will explore the use of standardized instruments in designing and using simulations for maximizing return on references. This is in addition to the most often-used selection tool, the pre-employment interview.

He will also discuss other important areas of the hiring process, like defensibility and avoiding complaints from unsuccessful applicants, ways of judging a candidate’s interpersonal skills, other capabilities and motivators, and other factors which determine whether there is a good fit between the individual, the position, and the organization.

In addition, Harry will also look at adding other selection tools such as testing and simulations (job samples) to the selection tool mix, which can greatly improve prediction accuracy and provide an alternative view of candidate skills, and techniques which improve the usefulness of reference information, including eliciting vital information from sometimes reluctant sources.

Harry will cover the following areas at this seminar:

  • The big-picture look at selection/promotion
  • How to analyze position and organizational requirements
  • Effective recruiting
  • Designing and using screening tools
  • How to design and conduct high-yield interviews
  • Adding testing and simulations to the selection toolbox
  • Avoiding legal problems
  • Maximizing return on reference inquiries
  • Putting it all together – designing a selection process.

The interconnectedness between human resources and project management

Although a superficial look may suggest nothing in common between HR and project management; upon scratching the surface a bit, one discovers a close relationship between the two. Project management and HR are very closely related to each other, if one considers the similarity in the approach to the two disciplines:

Project management is rooted in planning. A detailed, systematic, team-involved plan is at the core of successful project implementation. Therefore, the project leader who plans well succeeds in executing the project and taking it a notch higher.

hr3

The ability to plan precisely is of equal importance for HR, because much of what progresses in the organization hinges on HR’s planning ability. When HR plans and implements properly and effectively, that is a sure prescription for the organization’s success and growth. Like project managers, HR is also expected to transform a vague concept into a measurable outcome by channeling a broad array of knowledge, skills, and resources toward a critical organizational goal.

A learning session on the link between HR and project management

A proper understanding of this link between HR and project planning is the learning that a two-day, in person seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be imparting.

professionaltraining

The speaker at this session, Cathleen Hampton, a professional consultant with over 25 years of HR experience, will talk about strategic and effective management and implementation of programs and ways in which HR professionals can facilitate both of these in their organizations. To gain learning of the crucial link between HR and project management, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900725.

Understanding the similarities

Over two days of learning, Cathleen will expose participants to the basic principles concerning the nuts and bolts of planning, scheduling, and budgeting. These will be the outcomes of this learning:

  • Strengthening of skills and understanding how to generate valuable benefits for the organization by achieving crucial results that align with organizational objectives
  • Knowledge of the communication skills it takes to get ideas, instructions, and requests across quickly and accurately, thereby minimizing development time
  • Effectively using resources to stay on top of deadlines and expenses
  • How to rebound quickly from surprises and setbacks
  • How to get the best from people who don’t normally report to them
  • These are the objectives of this seminar:
  • Learning the imperative questions to ask before even beginning
  • How to use the planning and scheduling tools that professional project managers use, such as GANTT charts, the critical path method, work breakdown structures, project management software, and others
  • Best practices for team work
  • Understanding when and how the “Murphy factor” could hit the project and impact it in a big way.

 

Assessment-based prediction is the basis to good candidate hiring

Hiring is among the most important activities for an organization, because it is the process by which the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up their mind by asking critical questions with which to make predictions about a potential hire. These questions could relate to how well the resource can perform in the assigned role, for how long the resource could stay in the organization, and making an assessment about the person’s ability to handle more responsibilities.

Not all HR and other hiring managers could be right all the time in predicting the outcomes of their actions about a candidate; yet, a good understanding of principles of assessing the candidate, combined with proper preparation and inculcation of a little disciple will go a long way in helping them become more accurate in their predictions. When the hiring managers are not too way off their mark in predicting the attributes of a useful hire, they are more likely to get a better candidate and avoid much of the unpleasantness that a bad hire can cause.

Learn the art of predicting the usefulness and relevance of a candidate

It is to equip participants with the tools needed to design a process for selecting and promoting for any position across any industry that a two-day, in person seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. This seminar’s Director is Harry Brull, who is President, Laurdan Associates, Inc. and Co-Founder of BCG Consulting Group.recruiter

To get an understanding of how to get the right insight into a selection process that is relatively error-free and effective, just log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900715.

Insights into getting the hiring and promoting process right

At this seminar, Harry will explore the use of standardized instruments in designing and using simulations for maximizing return on references. This is in addition to the most often-used selection tool, the pre-employment interview.

He will also discuss other important areas of the hiring process, like defensibility and avoiding complaints from unsuccessful applicants, ways of judging a candidate’s interpersonal skills, other capabilities and motivators, and other factors which determine whether there is a good fit between the individual, the position, and the organization.

In addition, Harry will also look at adding other selection tools such as testing and simulations (job samples) to the selection tool mix, which can greatly improve prediction accuracy and provide an alternative view of candidate skills, and techniques which improve the usefulness of reference information, including eliciting vital information from sometimes reluctant sources.