Biotech and Pharmaceutical Courses are a gateway to a challenging and flourishing career

With over four million employed directly or in allied sectors and catering to the world’s largest market and research area, biotech and pharma is a fast growing industry. Its courses are designed to prepare individuals for this giant industry.
Biotech and pharmaceutical courses are much sought after by aspiring professionals in the field of biotech and pharma. This is why:

• The US is the world’s largest market for pharmaceuticals, as well as being the world leader in biopharmaceutical research
• Research by Pharmaceutical Research and Manufacturers Association (PhRMA) has revealed that the majority of the world’s research and development (R & D) in pharmaceuticals is conducted by U.S. firms
• These firms hold the intellectual property (IP) rights on most new medicines.

Huge in every sense

Around 5,000 new medicines with approximately 3,400 compounds are currently being studied in the United States, the longest pipeline in any region in the world. The pharmaceutical industry employs nearly a million people and supports more than three times that number in related and supplementary industries. All these place a high demand on biotech and pharmaceutical courses.

What should those aspiring for courses look for?

Certification is the primary criterion to look out in those seeking a biotech and pharmaceutical courses. Whether it is classroom or online courses that are opted for; certification by a certifying authority should be the determining admission to biotech and pharmaceutical courses.
CFPIE or the Center for Professional Innovation and Education Inc., BioPharma Institute and Center for Professional Advancement (CFPA) are some of the better known providers of certified biotech and pharmaceutical courses. This is a partial list of the areas on which courses are offered by these institutes/centers:

The following tripod of software-related issues forms the IEC 62304:2006’s foundation: These three attributes form the backbone of the test of a medical device company’s successful compliance with the regulatory requirements. For a medical device company to be successful in applying ISO 14971:2012 and IEC 62304:2006; it has to implement a cross-standard and resourceful way of integrating activities covering these requirements documents.

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The importance of meeting Supplier Management criteria

Meeting the supplier management criteria set out by the FDA, the ISO and the QSR regulations is mandatory for the regulated industries. The qualification and assessment of suppliers is binding for the regulated industries. Being in compliance with the requirements for supplier management set out by the FDA and by the ISO and QSR standards is a sure means for organizations in the regulated industries to keep the costs of noncompliance down, as well as in helping to meet customer requirements and ensure control over their suppliers and the regulations.
This requirement assumes greater significance when the fact that the suppliers are exempt from the jurisdiction of both the FDA and the Notified Bodies in the EU is taken into consideration. It is only over the organizations that use suppliers that these agencies have authority. So, it is entirely up to the organizations in the regulated industries to ensure that they meet the criteria set out in these regulations and that they conform to the supplier qualification and assessment criteria. It is entirely their responsibility to ensure that they have sufficient control over the processes that go into supplier management. The core of this arrangement between the organization and the supplier is risk management, which is a very critical mitigation tool in the supplier management system.
Expected in all stages of the QSR and ISO

Given that the full burden of ensuring supplier control rests on the organization; the latter has to ensure that it selects the supplier who is capable of thoroughly meeting the requirements set out by the regulatory agencies, on behalf of the organization. The supplier needs to be able to meet supplier qualification and assessment in accordance with the regulations set out by the QSR and ISO standards. However, contrary to popular belief, it is not necessary to spend a lot of money to ensure this. As many examples have shown, organizations can show compliance with ease with limited expenditure. How are they able do this?
A seminar on putting a compliant supplier management system in place
This is the essence of the learning from a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. This seminar will impart the skill and knowledge needed for putting in place a supplier management system that is both compliant with the ISO and QSR requirements and is yet cost-effective.
Jeff Kasoff, who is Director of Regulatory Affairs at Life-Tech, Inc., will be the Director of this seminar. Jeff has spent over 30 years in quality and regulatory management, during the course of which he has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startups to those with more than $100 million in revenue. Please register for this seminar by logging on to The importance of meeting Supplier Management criteria. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Complying with both QSR regulations and ISO standards

Jeff will help participants of this seminar gain insights and knowledge of how to accomplish their supplier qualification and assessment that meet both the QSR regulations and ISO standards in a cost effective manner. In his review of the QSR and ISO requirements for supplier evaluation; Jeff will give a definition of the types of suppliers that require evaluation. He will also describe the QSR/ISO requirements for supplier assessment.
Considering the inescapable link between risk management and supplier qualification and assessment, the Director will show how to implement a risk management plan that is effective and will help participants to add value.
Discussion on the core areas of supplier management
Jeff will devote considerable attention to supplier nonconformance, a critical area of supplier management. He will put participants at ease with the ways of how and when to issue the Supplier Corrective Action Request, a highly detested action. Before it gets issued, all the options need to be exhausted. Jeff will show which these are, as well as the knack of handling supplier nonconformance adroitly. While highlighting the importance of collaboration in the approach towards suppliers; he will explain the kinds of behaviors that risk alienating or losing suppliers.
While putting in place a supplier management and system that meet all required regulations and guidance documents is imperative to all businesses; it is more so for outsourced processes such as contract manufacturing, sterilization and testing, and also for critical suppliers. By default, this system makes dependence on suppliers inevitable.
Yet, having in place a system which ensures that they have sufficient control over their suppliers, as well as to assure auditors and regulatory agencies that the product is safe and meets all the quality requirements, is a must for organizations. Jeff will show how this can be achieved. Ensuring the cost-effectiveness of the compliant supplier management program is very important. Not doing so eats into the gains of compliance and being in control. Jeff will teach ways by which this scenario can be avoided.

Enroll for FDA, Medical Device; Pharmaceutical Courses Just $10 each

Well, you can spend $10 to do a number of things. You can have a cup of coffee for you and your friend. You can buy an ice-cream each to two of your kids. You could buy them a couple of comic books. Or, you could choose to grow up in your profession. Wait a minute. Is there something wrong with the last of these options? Growing up in one’s profession? For $10? Yes, you are reading this right. It is neither a typo nor the height of exaggeration. Growing up in one’s career by enrolling for an FDA, medical device or pharmaceutical course for $ 10 each is a possibility. In this place and time. GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, makes this possible!

Want to confirm if this is true? Please log on to GlobalCompliancePanel’s website to check on the dozens of recorded webinars that are available for all of $10. The original cost of these webinars is $ 265. So, what does this mean? It means that you have a jaw-dropping discount of 95% on each of these FDA, medical device or pharmaceutical courses. Can anything be sweeter to hear for a Regulatory Affairs professional?

From the time it started training professionals in the areas of regulatory compliance, GlobalCompliancePanel has been fired by the zeal for taking these training courses to a wider audience of regulatory compliance professionals. It has been training professionals in all the areas of regulatory compliance to help them get on par with the times and the changes that keep happening in their professions.

This is the latest endeavor from this well-known provider of professional trainings for the regulatory compliance areas. These courses are designed to help regulatory professionals take important steps towards scaling up in their professions and meet the regulatory demands set out by the regulatory agencies. 

A look at some of these webinars:

FDA:

FDA inspections are considered one of the most delicate tasks a professional in the regulated industries can come across. This course from GlobalCompliancePanel teaches participants just what they need to do when an FDA inspection happens at their facility.

Medical Device:

Medical device companies are up against a slew of regulations from the FDA, EMA, and other regulatory agencies. They cannot get any of these wrong, if they have to meet the requirements and market their products and stay in the market. At this course, GlobalCompliancePanel equips them with everything they need to understand about the European Union released directive 2007/47/EC (amending Council Directive 90/385/EEC).

Pharmaceutical:

Harmonization with the ICH-Q10 is very essential for a pharmaceutical company’s Quality System. The FDA aims to promote a pharmaceutical Quality System to build on the 21 CFR 820 it formulated in 1996. Participants can gain complete understanding of this topic by enrolling for this webinar from GlobalCompliancePanel.

Sign up today! This is an opportunity you cannot afford to miss!

Contact Details:

http://www.globalcompliancepanel.com/webinars_home 

John.robinson@globalcompliancepanel.com 

Support@globalcompliancepanel.com

+1-800-447-9407