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

Technical training in the life sciences

It is accepted that Training and Development is a highly developed area that bring its own body of knowledge. It uses a wide variety of techniques and approaches that are designed to meet the unique and complex challenges associated with training. Training and development is a great tool for helping a professional or a lay person alike understand the tenets of their profession.

In the absence of the right professional training and development, many employees place themselves at a disadvantage vis-à-vis their colleagues. They need to keep upgrading their knowledge and skills and keep closing the gaps, so that they do not get left out in their career. Training and development also helps employees understand how they need to meet the regulatory requirements the organization is required to comply with.

Difficulties associated with training and development in the life sciences

While this is accepted, a great deal of attention is yet to be paid to the need for technical training in the area of life sciences. Applying technical Training & Development skills to the field of life sciences is very crucial, as it helps professionals in that important area take a fresh perspective of the regulations in the areas of life sciences and benefit from them.

Technical training in the life sciences applications is fraught with a few problems. This is because two important factors come into play: The activities involved in the life sciences, such as formulating Standard Operating Procedures (SOPs), work instructions, the ways of carrying out tests and clinical trials, and the exact science behind the topics in this subject are all very complex. Secondly, regulations are equally difficult to understand and implement. This however, is no excuse to skip their implementation, something that is unthinkable for this industry.

A thorough learning session on technical training for the life sciences

It is to help professionals in the life sciences become more familiar with training and development, and to ease the complexity of their training needs that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar.

Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that is celebrating its twentieth year of existence in 2017, will be the Director. To understand the importance of technical trainings for the life sciences and to get to know how to implement legally compliant life sciences training programs for your organization, please enroll for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900920SEMINAR?wordpress-SEO. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Arousing the interest in training for the life sciences

The purpose of this seminar is to help kick start the training and learning needs of talented and technically competent training professionals who may need more focused instruction and direction in the area of technical training in the Life Sciences. Charles will offer guidance to all training professionals at all skill levels in how to truly build and sustain a training organization in today’s difficult corporate environment, and how to effectively identify gaps in workforce training and compliance documentation and build effective and inexpensive training materials with the tools that are available.

A very important benefit participants of this seminar will take away from here is that they will learn how to integrate Training & Development with compliance, so that they can leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.

Important personnel in the life sciences industries that are associated with training, such as Directors of Training, Training Supervisors, Training Coordinators, Training Developers, Instructional Designers and Instructors will derive high benefits from this seminar. Over the two days, Charles will cover the following:

o  Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance

o  Training and Development Basics

o  The Building Blocks of Human Performance

o  Building a Training and Development Organization – Leverage what you have and Negotiate for What You Don’t

o  Perform a Documentation and Training Analysis – Discover the Gaps

o  Training Materials – SOPs and Work Instructions as Training Materials – It’s not as easy as you think! Leverage the Opportunity!

o  Working with Subject Matter Experts and Outside Consultants

o  Case Study Review and Discussion – This Approach Works!

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.

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!

 

 

Team development is an integral part of leadership

Team development is a critical aspect of leadership, because leaders, like statesmen, think about the next generation. Leaders not only select and mentor leaders; they also make sure the leadership abilities get transferred to the new generation. For this reason, taking the organization to its next destination and grooming leaders requires team development. Team development is an extremely important endeavor for a leader.

Team development and leadership are closely hemmed together, because a team that lacks good leadership focus and direction will never be a winning one. There are many vital differences between leadership and management. Leading from the front and building a team is one of the prime distinctions between a leader and a manager, because these traits are never expected from a manager. Many leaders are up against many situations. These are some of them:

o  Knowing when to manage and when to lead the team

o  Foreseeing and visualizing organizational goals and communicating them to the team

o  Ascertaining the market’s needs and helping the team channelize its efforts more effectively

o  Addressing workplace challenges by devising creative solutions for the team

o  Devising strategies to develop a high-performance team

o  Communicating effectively to motivate and coach.

Learn all about leadership and team development

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will equip participants with the insights needed for understanding all these aspects of leadership and team development. The essence of this session is to equip participants with the skills and knowledge needed to inspire their team members and help them reach their goals.

Gaining these insights is easy. You can register for this webinar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900818?wordpress-SEO .

The Director of this seminar is Chris DeVany, who is Founder and President of Pinnacle Performance Improvement Worldwide. The varied experience he has had, in having helped some 500 organizations such as Microsoft, Coca-Cola, Aviva, and Schlumberger in 22 countries, will come to the fore at this seminar.

Leadership and team development in all their depth

DeVany will offer a thorough understanding of the role of leadership in building a team and working in a horizontal mode of operation and applying a consistent theory in leading a team.

This session will be very useful for CEOs, Senior Vice Presidents, Vice Presidents, Executive Directors, Managing Directors, Regional Vice Presidents, Area Supervisors, and Managers.

Chris will cover the following areas at this seminar:

o  Understanding leadership style and the situation

o  Integrating your leadership and managerial roles

o  Examining the leader’s role as motivator and coach and in high-performance teams

o  Distinguishing the three team types

o  Exploring the principles that make teams work

o  Differentiating team content and process

o  Diagnosing work-teams: a work-team simulation.

Unravelling the DHF, Technical File and Design Dossier

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Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

 

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Outstanding characteristics of the Design History File

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What should the Design History File contain?

The DHF should contain the following:

dhftechnicalfileanddesigndossier2

 

Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

Learn more on this topic by visiting  :  http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746SEMINAR?wordpress-SEO

 

 

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD)

The Design History File (DHF), the Technical File (TF) and the Design Dossier (DD) are core regulatory documents for a medical device. This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EU’s regulatory body, the Medical Device Directive (MDD). These documents constitute core regulatory requirements within these regulatory bodies.

The DHF on the one hand, and the TF and the Design Dossier on the other, have a lot of similarities as well as dissimilarities with each other. At a basic level, the major similarity between them is their intended purpose, while what they should contain is the main difference between the two.

If US medical device companies seeking to go global have to compete at a global level, they must meet an assortment of product design documentation standards. The Design Control and the Design History File (DHF) are mandated by the FDA’s CGMPs in 21 CFR 820.30, while for the EU; the core requirement is its CE-marking documentation –the Technical File or Design Dossier, as described in the MDD.

A thorough understanding of Design History File, the Technical File and the Design Dossier is necessary

All the complexities and in-depth clarification relating to these subtle matters about medical device regulatory requirements will be unraveled at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. John E Lincoln, who is Principal of J. E. Lincoln and Associates LLC, a consulting company and a senior Consultant in the Medical device and Regulatory Affairs areas, will be the Director at this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. To register for this seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746?linkedin-SEO .

Complete knowledge of Design History File, the Technical File and the Design Dossier

At this seminar, Lincoln will examine the existing and proposed requirements for the FDA’s DHF, which includes a discussion of its derivative documents, the DMR and DHR. He will explain what the European Union’s MDD TF/DD requirements are, along with an evaluation of the documents’ differing purposes and goals, their similarities, as well as the two different device classification schemes. All important aspects relating to these areas will be taken up.

These are some of the topics Lincoln will take up for discussion:

o  Areas requiring frequent re-evaluation or update

o  Similarities and differences

o  Future trends

o  Typical DHF Table of Contents

o  Technical File or Design Dossier Table of Contents

o  The importance and usefulness of the “Essential Requirements”

o  Structure of the “Declaration of Conformity”

o  Self-declaring or Notified-Body reviewed

o  Parallel approaches to development

o  The differing approaches to file audits by the U.S. FDA and the EU Notified Body.

Useful session for companies that need to handle Design History File, the Technical File and the Design Dossier

Being a seminar aimed at helping participants understand US and global standards for medical devices; it will offer valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files or Design Dossiers, documents, and activities/plan(s).

During the course of these two days, Lincoln will cover the following areas:

o  The Design Control requirements of the CGMPs, 21 CFR 820.30

o  The Design History File – documenting Product Design Control and its nine elements

o  The Device Master Record and the Device History Record

o  The EU’s Medical Device Directive

o  The “Essential Requirements”; and their documentation

o  The remaining elements of a Technical File / Design Dossier

o  Trends

o  Two attendee projects.