Seminar Calendar of Upcoming Courses – June to July – 2017

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GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

Key issues in HR auditing

Key issues in HR auditing

The importance of HR auditing can be gauged from the fact that it is about employees, an organization’s most valuable resource. It is through HR audits that an organization evaluates its strengths and weaknesses of its most important resource. HR audits have come a long way from the earlier times, when they were considered a set of checklists to be ticked. Today, HR audits in organizations consist of a whole gamut of sustainable and continuous audit activities that relate to critical areas such as governance, compliance and management in the organization.

Important benefits of HR auditing

HR auditing helps organizations:

o  Zero in on not only existing problems relating to HR, but also potential ones

o  Assess the efficacy of HR management practices

o  Understand the deficiencies of the HR internal control processes

o  Evaluate human capital and risks, both from the strategic and compliance-related perspectives

Rightly done HR audits enhance the value of an organization’s human capital and its competitiveness and bring down its susceptibility to employment practices liabilities by advising the management on what corrective steps it needs to take to resolve HR internal control processes.

Most importantly, HR audits should take human capital related risks and opportunities from the standpoint of Enterprise Risk Management (ERM), which leads to higher interaction between HR and management.

Proper ways of carrying out HR auditing

Although most organizations understand the importance of HR auditing and its uses; it is important for them to get the exact ways of implementing it. Getting their HR auditing right is the stepping stone to many important useful and corrective steps.

Risk management is the single most important ingredient that has to go into HR auditing. The proper ways of carrying out HR auditing will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

The Director of this seminar is Ronald Adler, a president-CEO of Laurdan Associates, Inc., a veteran owned, human resource management consulting firm that specializes in HR audits, employment practices liability risk management, HR metrics and benchmarking, strategic HR-business issues and unemployment insurance. Ronald brings vast and deep experience in all the areas of HR including HR auditing.

Professionals who wish to benefit from this learning can register for this seminar by logging on to Key issues in HR auditing .

The Director of this seminar will help organizations direct and focus their attention on their human resource management practices, policies, procedures, processes, and outcomes.

Asking the right questions

The foundation to sound HR auditing is to ask the right questions. Sharp, thoughtful, perceptive and insightful, they should prod management into getting into the depths of HR auditing. The ways by which to ingrain the habit of asking the right, meaningful questions will be the major learning this seminar will impart. Ronald will show the ways by which HR auditing needs to learn to throw up a structured and systematic series of questions about core areas such as key compliance, risk management, internal auditing, and human resource management issues to HR, which after all, is the real purpose of HR audits.

An understanding of how to ask these questions should be out of the realization that no two employees that HR auditing policies are focused on are alike. This way, Ronald will give clarity on the distinguishing nature of HR auditing.

HR auditing from the ERM perspective

A core aspect of HR auditing is that it should be inseparably linked to Enterprise Risk Management (ERM) for it to become effective and successful. To make this happen, HR auditing should take a broader and comprehensive view of human capital risks bring the interrelationships and interactions between HR and other functions relating to management and the organization in alignment with each other.

Ronald will explain these, as well as the ways by which HR auditing can help the organization identify and capitalize on potential opportunities and reduce risks.

HR professionals and others related to HR auditing, such as CFO’s, Internal Auditors, External Auditors, Risk Managers, Compliance Officers and COOs can benefit from the lessons learnt at this seminar.

He will cover the following areas at this seminar:

o  Review an overview of employment related risk management and HR Audits

o  Assess human capital risks

o  Develop HR metrics

o  Explore the HR audit model

o  Assess strategic alignment

o  Assess HR management related documents

o  Assess HR management processes and practices

o  Review the practical applications of HR audits.

Wrong hiring and ways of avoiding it

A perfect hire is a boon to any organization. At the other extreme, a bad hire can bring the inverse result to the organization: It can not only impede productivity; it can even result in drawing the organization into legal issues associated with wrong hiring. Problem employees create employee problems, which is why HR professionals need to be aware of what steps to take and what scenarios to avoid if they have to take hiring decisions that are legally defensible. A hire that is weak from the legal perspective is the stepping stone for troubles for the organization.

As if the legal troubles of wrong hiring are not enough; organizations have to also deal with the financial burden it brings. Many organizations have realized that in the absence of the right precautions, there is a near certainty that could end up hiring someone with a wrong background.

Facing embarrassing lawsuits

If an organization’s HR overlooks areas such as the candidate’s criminal record, or fails to take note of a falsified background, all that it is going to see is workplace violence, not to speak of lawsuits for negligent hiring and all the loss of time spent on finding the unsuited person.

Employers have to also face the prospect of inviting lawsuits for initiating screening methods that either violate the law or fail to take into account the changes in civil rights legislation and the new EEOC Guidance on the use of criminal records. This makes the screening process more complex than it ever was. It adds a new layer of woes for the organization, which has to bear the brunt of a wrong decision in hiring.

Get to understand all the aspects of legally compliant hiring practices

The way out is to gain familiarity with legally compliant best practices. This is the only truly proven antidote to not only keep the business productive; but to also make sure the organization will not be taken to court. Want to explore the ways of putting legally compliant hiring practices in place? Then, you need to enroll for a highly engaging and valuable two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this seminar, Lester S. Rosen, who is CEO and Attorney at Law at Employment Screening Resources, a national background screening company accredited by the National Association of Professional Background Screeners (NAPBS), will be the Director. To gain the benefit of the rich experience Lester brings into hiring best practices, please register for this seminar by visiting Wrong hiring and ways of avoiding it .

Touching upon all aspects of legally safe hiring and background checks

Over these two days, which will see a high level of interactivity, Lester will equip the participants with cutting edge tools, the latest legal developments and practical advice on the challenges of recruiting, background screening and hiring the best people for their organization. All those related to hiring practices, such as Human Resources professionals, Employers, Business Owners, Hiring Managers, Staffing Directors, Risk Management and Security Processionals, Staffing Professionals, Recruiters, and Background Screening Professionals will gain immensely from this session.

This seminar will help participants with the ways of obtaining and utilizing criminal records and background information on job applicants. The Director will update them on recent legal developments, and describe a few case studies which will help them understand the steps employers should take and the mistakes they should avoid. He will also familiarize them with the critical issues relating to hiring, such as the use of social networking sites, new technology and the EEOC approach to the use of criminal records and credit reports. Also taken up for discussion is the topic of why class action lawsuits are rising exponentially against employers and how to effectively comply with the federal Fair Credit Reporting Act (FCRA), as well as the many state laws that are in place for regulating background checks.

The Director will help participants understand with the immediate steps they can take to avoid a bad hire by putting in place a screening policy that withstands legal scrutiny. He will also traverse a variety of topics related to background checks such as:

o  The process employers should use in hiring to minimize the chance of a bad hire

o  The ways of adapting a background screening system

o  The ways of selecting the rightly suited screening partner

o  The most judicious ways of using social media, international background checks and drug testing.

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines are collectively termed Good Manufacturing Practices(GMP).

Not a uniform set of standards

It needs to be understood that GMPs are not a uniform or homogeneous set of rules for everyone to follow. These are general principles laid out for ensuring that there is a minimum level of quality requirements to be fulfilled.

Agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products recommend these guidelines. These guidelines can be accomplished in many ways, and it is up to the organization to find out the one that suits it best and implement that system.

In essence, Good Manufacturing Practices can mean the following:

  • GMPs are set practices that manufacturers need to put in place to ensure that their products meet specified quality standards.
  • GMP guidelines consist of the minimum requirements that food product, drug or pharmaceutical manufacturers have to meet to assure that their products are of the prescribed quality and cause no harm or risk to those who consume them or the public at large
  • Regulatory agencies in several countries oversee their respective countries’ and global Good Manufacturing Practices. Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) are usually analogous to GMP
  • In many countries, legislations require pharmaceutical and medical device manufacturers to comply with GMP procedures. Many require these organizations to create their own GMP guidelines that are line with their legislations.

Basic points in GMP guidelines

These are the current GMP compliance requirements for pharmaceuticals (some of these guidelines overlap with those for medical devices)

 

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Applied Statistics for FDA Process Validation

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.

These are the three stages:

I.           Process Design

II.           Process Qualification, and

III.           Continued Process Verification.

Stage 1, or what is called the Process Design stage, is the stage in which the commercial manufacturing process is defined. This definition is based on knowledge gained through development and scale-up activities.

Stage 2, called the Process Qualification, is the stage in which an evaluation is made of the process design to determine if the process is capable of reproducible commercial manufacturing.

Stage 3, the Continued Process Verification, is meant for giving ongoing assurance during routine production to ensure that the process remains in a state of control.

A seminar on the ways implementing Applied Statistics for FDA Process Validation

GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing a two-day seminar in which the ways of using Applied Statistics for FDA Process Validation will be taught. Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director of this seminar on applied statistics for FDA Process Validation.

In order to learn Applied Statistics for FDA Process Validation in-depth, please register by visiting Applied Statistics for FDA Process Validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A detailed and methodical approach to implementing statistical methodologies

This two-day course on Applied Statistics for FDA Process Validation will focus on the ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Beginning with a primer on statistics, Dr. Burdick will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

Dr. Burdick will next move on to explaining the two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays).

He well then show how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Given that the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

This seminar on Applied Statistics for FDA Process Validation will lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

All-round learning related to Applied Statistics for FDA Process Validation

Dr. Burdick will teach participants how to:

o  Apply statistics for setting specifications

o  Assess measurement systems (assays)

o  Use Design of Experiments (DOE)

o  Develop a control plan as part of a risk management strategy, and

o  Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation also provides a useful framework for other related industries.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Develop appropriate sample plans based on confidence and power

o  Implement suitable statistical methods into a process validation program for each of the three stages

o  Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)

o  Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ

o  Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till April 30. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

 

 

GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till March 31. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit http://www.globalcompliancepanel.com/ and use MGCP50 Promo Code.

This offer is valid till March 31, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!