Don’t miss out! Offer @ $10 – Online Professional Courses

7This is a great deal. What else does one call this offer $10 deal to enhance professional skill from GlobalCompliancePanel? Wait. We are talking about $10, but did we tell you what you get for $10? Did you think it is the cost of registration for the event? Well, be prepared to get proven wrong –for the happiest of reasons. $10 is the price of a single recorded webinar that GlobalCompliancePanel is putting up at this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

4Yes indeed, after all the rubbing of your eyes to confirm the truth of this seal, GlobalCompliancePanel assures you that it indeed has a great deal @$10 to enhance professional skills with GlobalCompliancePanel! Could regulatory trainings become more inexpensive and more affordable? Nowhere else in the market does one something of such high value as professional trainings in the regulatory compliance area for this price. Of course, a lot of items are available in the market for this price. Let us talk about a few toiletries. Let us talk about a few used books. Let us talk about some children’s clothing. But professional trainings that will take your profession as a regulatory compliance professional a few notches higher, at $10? Well, you can take your time to believe this, but it is true.

8This great deal @$10 to enhance professional skills with GlobalCompliancePanel is open to all professionals who want to enhance their skill and learning of the regulations in their respective domains of specialization. Who wouldn’t want to, at this price? When professional trainings in regulatory compliance becomes available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel; what could be a better means to spend your ten dollars!

4What is the motive behind this offer? Simple: GlobalCompliancePanel has been a provider of professional trainings for the regulatory compliance arena for a good ten years now. It has become an established name in this area. It thought, why not make our trainings more wide-ranging and accessible to many more professionals? After all, regulations do keep changing every now and then. Shouldn’t regulatory professionals keep pace with them?

3A rich assortment of courses is available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel. You can choose from trainings that help you with nuances of how to establish a reduce testing program for pharmaceutical and medical device components, where the guru of starting up, developing, implementing, managing, and remediating pharmaceutical and medical device Quality Systems, Howard Cooper, will show how to derive the benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.

9Are you at odds when it comes to designing, planning and conducting effective audits? Then, why don’t you purchase this webinar that comes as part of great deal @$10 to enhance professional skills with GlobalCompliancePanel, in which Mark Roberts, Head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance, will offer his insights?

There could be no better means to improve your knowledge of regulatory requirements. And the time is now, with this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

Contact Details:

https://www.globalcompliancepanel.com/webinars_home?wordpress-2017-SEO

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

Learn any professional courses for $10 only

GCP Offer 4

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each.

GCP offer 7

Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many professionals consider it expensive. But not anymore. GlobalCompliancePanel makes it possible to scale up in one’s career. What used to cost $265 is now available for $ 10, at about the price of a T-shirt. See the math: It is a saving of about 95%.

Myriad number of courses

GCp offer 9

Regulatory compliance, as we all know, is a really vast area of knowledge. With the FDA framing innumerable laws and regulations on every area that it regulates, it is imperative for regulatory professional to show compliance with the regulations. They are doomed if they fail. GlobalCompliancePanel brings hundreds of courses in all the areas of regulatory compliance to help professionals understand how to meet these stringent standards.

GCp offer 10

Want to explore what expectations the FDA has of the drug development process? Want to understand the nitty gritty of drug development and how to meet the FDA’s stringent requirements as far as IND and NDA requirements, or nonclinical or the human clinical studies required for it? Then, take a look at how GlobalCompliancePanel can help you achieve this, for just $10.

Are you working in an industry in which you are required to carry out Root Cause Analysis, but are having problems with it? Understand the fundamentals of Root Cause Analysis and get to know how to determine what caused the problem, why it happened, and what to do about it to reduce its likeliness of occurrence, with this course from GlobalCompliancePanel.

GCP offer 8

Have you understood how to get HACCP validation done for your facility? Do you have a problem in grasping its validation and verification? No worry. This recorded webinar from GlobalCompliancePanel will set you on the path to it. At just $10, it will offer you the knowledge you need for understanding how to tackle supplier and other issues and put in place a robust HACCP validation and verification program.

This is just a small sample of the many courses that are on offer for $10 each. Want to explore how many more courses are on offer at this huge discount price? Then, just visit our website to open up the possibility of unlimited learning. All that you need to spend is just $10 to enhance your learning on an area of regulatory compliance.

GCp offer 11

Contact US:

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

Registration Link –

https://www.globalcompliancepanel.com/webinars_home?wordpress-seo-gcp-webinar-offer-2017

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

 

 

 

Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel

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Healthcare professionals now have a stronger reason than ever before to enroll for professional learning courses and upgrade their knowledge. GlobalCompliancePanel, a highly reputable provider of professional trainings for all the areas of regulatory compliance, will offer a pick of their healthcare compliance courses for just $10.

Healthcare professionals have always been flocking to GlobalCompliancePanel to partake of professional trainings courses that are valuable, relevant and highly interesting. They will now have more reasons for doing so and join thousands of healthcare regulatory professionals who have already benefited from GlobalCompliancePanel’s professional trainings, because it is not every day that one comes across an offer in which the professional gets to pay a mere 5% of the original price of the webinars!

These recorded webinars are on a number of topics concerning healthcare. Healthcare professionals can use these courses to augment the learning they have gained over the years and climb up in their professions with even greater ease. What’s more; healthcare professionals have such a huge number and variety of courses to choose from that they can opt for several courses of relevance to them without burning a hole in the pocket.

Why is GlobalCompliancePanel doing this? Simple: It wants more and more healthcare professionals to take up courses that are relevant and valuable to them, so that the knowledge needed for becoming successful in their careers spreads wider and goes deeper. After all, meeting regulatory compliance requirements is the number one challenge for any healthcare professional, who sees no way out of the regulatory maze without the professional trainings needed to understand them. When such a course is available at a throwaway price of $10, isn’t that a delightful thing to have?

Let us feature a couple of the topics on which GlobalCompliancePanel is offering these courses to healthcare regulatory professionals:

The HITECH Acts Impact on HIPAA

HIPAA enforcement is a matter of serious concern to many healthcare professionals. Many of them, even highly experienced ones, are clueless about some of the aspects of this enigmatic law. When HITECH combines with HIPAA; the confusion is doubled. The two laws intersect at many places, thus compounding the complexity of enforcement. This webinar from GlobalCompliancePanel offers clarity and helps them ease the confusion about this law.

Further, the nature and roles of a host of HIPAA-related items such as breach notification, business associate contracts, training of staff and security of PHI for Business Associates can be daunting to understand and implement. Webinars such as this are designed to help healthcare professionals steer clear of the stumbling blocks that they could encounter in implementing these.

Preparing a Medical Product Regulatory Requirement Plan

What happens when healthcare companies fail to meet regulatory requirements set out by the FDA and other regulatory agencies? The consequences are disastrous, and can range from penalties to having their business shut down. One of the foundations to avoiding this sort of situation is to develop a medical product regulatory requirement plan.

A medical product regulatory requirement plan charts out the regulatory requirements  that need to be met from step one, which is quite literally Day One of the start of the process of making healthcare products. A detailed and organized medical product regulatory requirement plan is indispensable to ensuring in the end that the healthcare product meets the regulatory requirements.

It is this priceless learning that this webinar from GlobalCompliancePanel imparts. And yes, at $10!

Drug Safety and Pharmacovigilance

Pharmacovigilance, a crucial area of healthcare, needs to be implemented in full according to the requirements set out in regulations from the FDA, EMA and other regulatory agencies. Drug safety being deeply tied to PV; the proper implementation of the latter is needed to ensure the former.

PV is essentially about ensuring drug safety by implementing measures throughout the process of production. A healthcare company has to comply with directions from a number of regulatory agencies in order to have its products passed by them and to gain permission to enter different markets. They cannot afford to take one wrong step in the whole process. A number of areas such as clinical trials, marketing, disease management and government are just some of the areas in which pharmacovigilance is indispensable.

This webinar from GlobalCompliancePanel is a great means to getting a complete understanding of this intricate topic. The topic is of great relevance to healthcare professionals, but what’s more; it comes at this unbelievable price tag of just $10!

Contact Details:

http://www.globalcompliancepanel.com/webinars_home

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

It is important and necessary to document Software for FDA Submissions

It is important and necessary to document Software for FDA Submissions2Software project management has an important tool in the Agile methodology. The Agile methodology developed as a product of the gradual efforts at arriving at a team based methodology of iterative software development. Because of its close association with software, in terms of suitability; Agile is to software development what Lean is to manufacturing. Among the many areas in which the Agile methodology is very well suitable and adaptable; healthcare is one, since it uses software heavily.

The Agile methodology is effective in helping software project managers anticipate and address major logjams of software project management, such as vulnerability and unpredictability. By preventing project delays; Agile helps to cut costs. Since flexibility is an important characteristic of Agile; it has the ability to accommodate and take in many new changes that take place as the project develops.

Another major benefit of Agile is that it prevents piling of work at later stages of the project by reviewing project progress at every stage by validating roles, steps and processes functions. This is absolutely useful in the backdrop of severe constraints of time and money, because of which it is highly preferred and rated by Project Managers.

Is Agile perfect?

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All these terrific advantages notwithstanding; Agile is not perfect. It is not suited in every setting and in every situation. If Agile has to be efficient and deliver its results optimally; it has to work in conditions where there is complete, tightly knit team coordination. In the absence of very active and strong participation from the team leaders, subject matter experts and stakeholders; Agile can prove less than suitable or successful.

Agile’s suitability for the healthcare industry is well-established. However, Agile, being a highly teamwork-dependent initiative can fail to deliver in the absence of one or more situations in which it thrives. In the absence of complete confidence by those using it in the healthcare industry of its role in saving money, time and other resources; the Agile methodology can be less than useful

Get to learn the applicability of Agile methodology to healthcare

Business.

The ways by which the healthcare industry can adapt and optimize Agile methodology for its use and overcome the deficiencies and shortfalls of this methodology for enhanced performance will be the topic of a very interesting two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance.

The Director of this seminar is Brian Shoemaker, who consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures, and has worked with companies in Germany and Switzerland as well as the U.S. Please register for this session by logging on to It is important and necessary to document Software for FDA Submissions. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity on the suitability of Agile to IEC 62304

It is important and necessary to document Software for FDA Submissions3

A criticism that does the rounds in healthcare software industry circles is that Agile, because of its lack of documentation, runs counter to the lifecycle standards mandated in IEC 62304. Brian will clarify on this area and explain how clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution, which go into the IEC 62304 principles actually reinforce, rather than undermine the Agile methodology. The proof of this fact is that the AAMI Agile report (TIR 45) has stated that the proper application of Agile, with its emphasis on nimbleness and ongoing learning, into a quality system and safety risk management can blend with and expedite the fulfilment of regulatory expectations of well-documented development.

Contrary for popular belief, documentation in Agile actually helps in taking advantage of iterative development. How? Since the IEC 62304 does not specify any lifecycle model; documentation can grow out of the required iterative activities. Agile, by developing incrementally and preventing last minute anxieties and worries; is highly useful in many disciplines of healthcare such as hazard analysis. When risk management is included in iteration tasks; it becomes more robust and solid.

It is because of all these reasons that this is a session that professionals across a wide spectrum of positions such as Regulatory Specialists, Quality Assurance Specialists, Documentation Specialists, Test Managers, Software Team Leaders and Lead Developers, and Project and Program Managers ought not to miss out on.

They will get thoroughly familiarized on the applicability of the Agile methodology to software documentation for FDA submissions. Over these two days of this seminar, Brian will cover the following areas:

  • Agile vs IEC 62304: an apparent contradiction?
  • The role and value of documentation
  • The REAL regulatory requirements
  • Specific documents required for an FDA submission
  • Areas where most development processes bog down
  • Iteration – well suited for risk, usability, and design reviews
  • Key practices to bridge the Agile and regulated worlds
  • Agile is not only acceptable for medical device software, but can be clearly superior.

 

 

Effective legal writing skills are essential for FDA submissions

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A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA are deeply technical in nature, because of which they make heavy reading. Being the product of studiously and meticulously carried out research and finding, these submissions are very scientific and technical. Mastering the art of making legal writing effective and embellishing it is necessary for those who make FDA submissions because this can make these documents lucid and pleasant.

It is the habit of most law schools to prepare future attorneys by teaching them the art of summarizing and sharpening intricate and heavy textual and academic matter into crisp, concise and credible arguments. It is in situations such as drafting responses and applications to FDA that these kinds of writing skills become vital. The FDA expects responses to their queries, or for that matter, any poser that requires a response, to be very exact, scientific and technical. So, developing the art of effective legal writing skills for FDA submissions is a big need for those who prepare legal documentations.

Ridding submission documents of heavy text

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Making submissions about the product apart; effective legal writing skills for FDA submissions need to be developed for another important reason. Companies have to paddle through a muddle of legally heavy, often confusing regulations, which are legally binding requirements that are based upon statutory laws and judicial opinions.

Professionals in the pharmaceutical and medical device companies are required to handle these and respond to these at the appropriate times. A firm grasp of the requirements for doing this is needed for clearly understanding how to frame persuasive arguments and to negotiate with the FDA.

Effective legal writing skills can contribute to success in FDA submissions

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Effective legal writing skills for FDA submissions can stand between the success and failure of many new drugs, biologic or medical device projects, because a document that is confusing and is laden with incomprehensible jargon confuses the regulatory authorities and could become a reason for rejection of the submission.

This is why the more persuasive and articulate these arguments; the greater the chances for the company’s products of getting approvals from the FDA. All these facts make the cultivation of effective legal writing skills for FDA submissions extremely important.

Major learning on effective legal writing skills for FDA submissions

Effective legal writing skills are essential for FDA submissions

The ways of making legal writing skills effective for FDA submissions will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

The Director of this highly important and rewarding session on legal writing skills for FDA submissions is Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com.  In order to get clarity on how to develop the right tools needed for effective legal writing skills for FDA submissions, please register for this webinar by just visiting Effective legal writing skills are essential for FDA submissions

Effective legal writing skills for FDA submissions improve the chances of success

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At this very valuable webinar on effective legal writing skills for FDA submissions, Robert will familiarize participants with the legal writing skills and practical techniques that will enhance their chances for success. Good regulatory writing may help to meet FDA branch-level requirements; but effective submissions that are laced with effective legal writing skills for FDA submissions can withstand scrutiny at the FDA Division level.

The seminar will be highly useful to any person working in Regulatory Affairs or Quality Management who is responsible for summarizing data and technical results, obtaining regulatory clearance or approval of a product, and selling or marketing regulated products. These include Regulatory Affairs professionals, Quality Assurance professionals, Marketing professionals, Scientific and Engineering/Product Development Managers, and Consultants to any regulated industry.

At this webinar, Michalik will cover the following areas:

Quality Assurance Auditing for FDA-regulated industries

Quality Assurance Auditing for FDA-regulated industries5

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A Quality Assurance audit should also ensure that the activities the company that is being audited is carrying out are within the legal guidelines and frameworks laid out by the respective regulatory authorities.

Two types of audits

Quality Assurance Auditing for FDA-regulated industries3

An organization that is in an FDA-regulated industry is required to carry out internal and external audits. The purpose of this dual type of audit is that one complements the other and the two together reinforce the audits. As the two terms indicate, an internal audit may be thought of as being a tool for self-examination. It is an audit that the organization’s own employees carry out to scrutinize the usefulness of the systems. An external audit, on the other hand, is one that is performed by an independent person who has the qualification and purpose for this kind of work. The purpose of both these types of audits is the same.

Audits based on process

Quality Assurance Auditing for FDA-regulated industries1

The core principle on which audits for the FDA-regulated industries are carried out as part of a Quality System is that since testing alone is not sufficient to ensure quality; quality should be inbuilt into the product. This approach, called the process based to auditing; has to, naturally, be based on an in-depth understanding of the entire set of processes that go into a Quality System before the commencement of the audit. A complete understanding of the processes relating to the business, control and production on the part of the auditors should be the basis to the process-based audit. Auditors then go about defining the criteria for the audit and the scope of the purpose they expect it to serve.

So, what to audit?

Quality Assurance Auditing for FDA-regulated industries

Since Quality Assurance auditing is generic to any FDA-regulated industry; a definition of what has to be audited is quite expansive. Based on the kind of the business, these are the important areas in which audit is carried out:

  • Product
  • Process
  • Quality System
  • Regulatory
  • Supplier
  • System
  • Management

The four phases of auditing

Four self-explanatory phases go into an auditing process:

  • The preparation stage
  • The performance stage
  • The Reporting stage
  • The follow-up and closure stage

Auditing of management systems

The ISO 19011

The ISO 19011

The ISO introduced the ISO 19011 management systems audit. The ISO makes it mandatory for companies to also audit the management systems along with Quality Systems. This is done to ensure completeness of the audit.

Passed in 2011, the ISO 19011 is the guiding principle for auditing a company’s management systems and the ISO standard for auditing a company’s management systems.

Full understanding of all elements of audits

A detailed explanation of the ISO 19011 and all other aspects of an ISO audit will be given at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

At this seminar, David Dills, Global Regulatory Affairs & Compliance Consultant who provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems; will be the Director.

Please log on to Quality Assurance Auditing for FDA-regulated industries to enroll for this seminar. This webinar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Benefits of participation at this seminar

Participants who attend this seminar will benefit in a myriad of ways. David will offer the following at this seminar:

  • Clear Understanding of Auditing Fundamentals
  • Understand Audit Preparation and Planning
  • Learn best techniques for Audit Performance
  • Learn best practices for Audit Reporting
  • How to address Audit Follow-up and Closure efficiently and effectively
  • Understand the requirements and expectations for being an effective auditor
  • How to develop into an even better auditor
  • How to structure, plan and manage your audits
  • How to develop your technical and non-technical skills
  • How to perform your best audit ever.

He will cover the following areas at this seminar:

 

 

 

Upcoming FDA FSMA Rules of Human and Animal Foods

The process of finalizing new food safety rules by the U.S. Food and Drug Administration (FDA) is underway. The accent of these upcoming FDA FSMA rules on the sanitary transportation of human and animal foods is the ways by which scientific and safe transportation and logistics involved in food transportation can be bettered. The FDA is required to establish rules for improving, auditing and enforcing new rules relating to food transportation. Congressional instructions have been issued for ensuring the establishment of these rules.

These are the aspects of food transportation that come under the ambit of these new FSMA Rules:

–       Foods not completely enclosed by a container

–       Preventing and reducing adulteration and risk

–       Training and certification of personnel for this purpose

–       Food inspection and collection of data

–       Maintaining compliance and reporting about its evidence.

Get trained on how to do this right

Since the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods apply to organizations that work in food transportation; these organizations have to ensure proper adherence to these rules. To do this, they need to first understand the rules and also know what it takes implement them. A seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance will offer this learning.

John Ryan, President, TransCert, QualityInFoodSafety, RyanSystems, is the Director of this two-day seminar. He will offer understanding and insights into the way the new Rules from the FDA apply to players involved in the transportation of human and animal foods.

The Director will also impart complete understanding of the ways by which to establish the right temperature monitoring, sanitation, container test and traceability, training and data reporting procedures and review the same. This seminar will also offer an understanding of the legal requirements of food transportation and how to develop a company plan that meets the expectations and requirements of both its customers and the FDA.

You can register for this seminar by visiting Upcoming FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

Technological aspects of FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

Dr. Ryan will offer insights into all the aspects of the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and help participants understand how to comply with them. In the course of this learning, he will cover the technological aspects of food transportation, which are gaining importance lately. These include new low cost GPS enabled traceability and temperature monitoring technology, EPA approved container sanitizers, washout technologies, temperature maintenance equipment, and food residue and bio-contaminant testing. Dr. Ryan will examine the close relationship these technologies have with the FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods.

Dr. Ryan’s assessment of the future of transportation food safety vis-à-vis new and evolving technologies will be peppered with references to upcoming technology providers. He will provide the participants of this seminar with Internet links that lead to more detailed information on the same.

Those in food supply chain logistics and food safety and security personnel whose primary responsibilities include management, sanitation, quality and operations; will find this seminar highly useful.  It will also be useful for personnel that handle incoming and outgoing food shipments, maintaining transportation equipment and tools, and purchasing or selling.

Dr. Ryan has the following agenda for this seminar:

o   Review of the FDA’s proposed rules on the sanitary transportation of human and animal foods

o   Review of other international transportation food safety guidance and laws

o   The meaning of adulteration

o   Review of Standards

  • Management
  • Sanitation
  • Hazard analysis risk-based preventive controls
  • Traceability and temperature monitoring
  • Training

o  GAP analysis

o  Learning what happens during cold chain food transportation through all processes

  • Farms
  • Air
  • Ship
  • Truck
  • Trays and Bins

o  Data, logs, forms and electronic record keeping

o  Shipment cargo theft, security and recall

o  Issues facing food importers and those buying from them

o  Return on investment (ROI) and marketing advantages

o  Future technologies (trans-oceanic, satellite, etc.)

o  Establishing an initial plan to implement your auditable system

  • Choosing which standards apply to your company
  • Flowcharting your process
  • Determining when and how you will perform a GAP analysis
  • Listing new procedures for your operation
  • Selecting and assigning key personnel.