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The Growing Safety Concern of Alpha Lipoic Acid and Hypoglycemia

Posted on September 29 2016 | Author: Admin

The Growing Safety Concern of Alpha Lipoic Acid and Hypoglycemia:
Marketed Health Products Directorate Issues ALA Summary Safety Review

August 08, 2016 Marketed Health Products Directorate provides Summary Safety Review for Alpha Lipoic Acid.

In an effort to increase transparency and consumer safety, Health Canada’s Marketed Health Products Directorate published a Summary Safety Review (SSR) on Alpha Lipoic Acid (ALA) on June 30, 2016. ALA is a medicinal ingredient generally used, in Natural Health Products (NHPs), as an antioxidant for the maintenance of good health and to help promote healthy glucose metabolism. ALA can also be used in NHPs, as a non-medicinal ingredient, with a preservative function. To date, Health Canada has licensed more than 800 NHPs containing ALA as a medicinal ingredient.

The Health Canada SSR issuance on ALA was prompted by reported international cases of Insulin Autoimmune Disorder (IAS) considered to be linked to the use of ALA containing products. IAS, also known as Hirata disease, is a rare case of serious and spontaneous Hypoglycemia. It is characterized by extremely low blood glucose, and extremely high insulin and insulin autoantibody levels. Current evidence suggests exposure to certain sulfhydryl-containing oral drugs such as ALA, in individuals with specific genetic predispositions, can induce Hypoglycemia and increase the risk of IAS. The reported cases demonstrate Hypoglycemia resolution following discontinuation of ALA oral consumption. At the time of the review, no Canadian cases of Hypoglycemia were reported as a result of ALA oral use. It is however unknown how prevalent the suspected genetic predisposition may be in the diverse Canadian population.

As a result of the SSR findings, Health Canada is looking into updating the ALA labelling standard risk information to inform consumers to discontinue product use and consult a healthcare professional if they experience symptoms indicative of Hypoglycemia (sweating, paleness, chills, headache, dizziness and/or confusion). Health Canada has also committed to publish a Health Product InfoWatch article to raise awareness of this potential risk and continue to monitor safety information involving ALA.


Article provided by dicentra

About dicentra
dicentra provides sought-after food safety guidance, compliance consulting services and scientific guidance for food and health-related products sold in North American marketplaces. Since 2002, dicentra has been helping clients resolve complex scientific and safety issues, develop safe and effective market-leading products and facilitate timely regulatory approvals. To learn more about dicentra, please visit www.dicentra.com

Click here to view the original article. 






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Management vs. Leadership: A middle manager’s perspective

Posted on September 21 2016 | Author: Jessica Bowes

The organizational structure of a company largely depends on the nature and size of the business. With innovation at the core, entrepreneurial businesses need to promote regular interaction and communication among its internal teams, regardless of how it’s structured, in order to follow through on the founder’s vision for success. For start-ups and early stage businesses that are too small to departmentalize, management resources must be maximized.

Companies need leaders
There’s a fine line between management and leadership, but there is a difference. Managers plan, organize and coordinate whereas leaders should inspire and motivate.  A successful entrepreneur needs to be both a strong leader and manager.

Strong leaders put others ahead of themselves, and the team ahead of everyone.  They make their expectations clear, even when it’s uncomfortable. They push people outside of their comfort zones. And, they hold people accountable while empowering them to learn and grow.

True leadership is like an inverted pyramid, where an entire organization relies on a single leader to support their efforts by providing vision and strategic guidance. This becomes particularly important once your business grows and you hire new staff to carry out your vision for the company.

Leadership and management must go hand-in-hand

“Management is about persuading people to do things they do not want to do, while leadership is about inspiring people to do things they never thought they could.”

-- Steve Jobs

As a manager, your duty is to implement company strategy in the most efficient way. You’re also responsible for creating an effective working environment, administrating the work process in compliance with organization’s requirements, leading people, and reporting to the highest level of management.

Functions of the role can typically be divided into 3 main categories, all of which can be profoundly impacted by the person’s leadership skills: Technical, Human Resources and Strategic.

Technical:
In the agri-technology sector, there is almost always an element of technical understanding required to manufacture, market or sell a product or service. Education and/or training of staff in this capacity may then play a significant part of the managerial role.  Relationships with staff that are built through patience, creativity, and supportive collaboration are indicative of good technical leadership.

Human resources:
Managers are also responsible for administering day-to-day routines, monitoring performance and making sure everything is done in compliance with company’s needs. One of the most important functions, directly associated with operational leadership, is motivating and inspiring staff to perform well. This also includes building a cohesive team and supporting team members when necessary.

Strategic:
Strategic functions of a manager may involve analyzing a group in terms of productivity and financial effectiveness, creating a strategy to improve the current situation and reporting to executive management.  Strong strategic leadership is grounded in understanding the relationship between the company and its environment, then thinking, acting and influencing the team to promote success. Strategic leadership is not limited as a task for a few top executives, but is needed throughout the company.

Every employee has the opportunity to lead
Fostering an environment where people feel empowered, appreciated, and genuinely happy to be part of the team will not only allow employees to shape and create their own futures, it will create career progression opportunities for employees to adapt, innovate and ultimately lead your company to success.

 

Jessica Bowes
Manager, Business & Technology Analyst Group

 

Sources 
Management vs Leadership: Five Ways They Are Different
The End of Middle Managers (And Why They’ll Never Be Missed)
The Three Strengths of a True Strategic Leader

 






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FSMA is Not Just Coming… FSMA is HERE!

Posted on September 15 2016 | Author: Admin

It’s been 5 years since you’ve first started hearing about looming FSMA deadlines. Now that the first deadline for 2016 has arrived, its time for you to understand how this will impact your business.

If your business is simply a retail or restaurant establishment, you initially may feel untouched by this legislation.  This assumption, however, may be very untrue.  Although FSMA is geared to food growers, manufacturers and distributors, businesses in other sectors that are not legally required to comply will still be impacted.  A supplier of ingredients to retail and restaurant business is fully impacted and so as a result, this will inevitably have an impact on all business not directly captured by the law.

It’s quite obvious that one of the main intentions of the new law is to give legislators at FDA more power to regulate and enforce.  The ultimate goal is to shift food industries from a reaction mode to a prevention mode. This shift will initially appear to be very costly and labor intensive, but the reduction in food safety incidents leading to recalls will outweigh all initial costs.

The first FSMA deadlines related to compliance to Preventative Controls for Human and Animal Feed are outlined below:

September 2016: Companies with more than 500 full-time employees
September 2017: Companies with fewer than 500 employees
September 2018: Companies with less than $1 million in average annual sales

Under FSMA each site will be required to have a “Preventative Control Qualified Individual” (PCQI).  A PCQI is required to have successfully completed training in the development and application of risk –based preventative controls.  This individual is responsible for:

  • Performing or overseeing the preparation of the food plan
  • Validating the preventative controls
  • Reviewing records for implementation and effectiveness of preventative controls
  • Appropriateness of corrective actions
  • Managing the required reanalysis of a food safety plant every three years or whenever changes occur

Being FSMA ready will mean moving from HACCP to HARPC as reviewed in previous articles.  While HACCP involves Critical Control Points (CCPs), HARPC involves controls that are not CCPs.

Supply chain control is essential and is obvious from the Foreign Supplier Verification Program.  This program has compliance deadlines in 2017, but has a huge impact on ingredients and foods coming into the U.S. from outside the country.

In order to import food from foreign suppliers, importers need to ensure they have:

#1. Determined known or reasonably foreseeable hazards with each food they are handling
#2. Evaluated the risk posed of the food they are importing based on the hazard analysis, and the foreign supplier’s performance
#3. Used the risk evaluation connected to the food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
#4. Conducted supplier verification activities
#5. Conducted corrective actions

Since importers are responsible for their own food safety plans, they are expected to reevaluate these plans every three years. This involves conducting a Hazard Analysis and Risk-Based Preventive Controls, or HARPC assessment on each item of food being imported, and verifying each supplier being used. Importers are also responsible for keeping detailed records of all data and analyses.

Under the Third Party Certification rule, FDA will be choosing accreditation bodies to implement the certification of qualified organizations who will confirm that the requirements of FSMA are being met.

This rule establishes a voluntary program for the accreditation of third party certification bodies, also known as auditors, to conduct food safety audit and issue certification of foreign facilities and the food for humans and animals they produce.  These certifications may be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP) which offers expedited review and entry of food.  To prevent potentially harmful food from reaching U.S. consumers, the FDA can also require in specific circumstances that a food offered for import is accompanied by a certification from an accredited third party certification body.

This article has not dealt with every aspect of the FSMA requirements, but it will hopefully give you an understanding of the areas in your business that need to change in order to come into compliance with the new expectations.


Article provided by dicentra

About dicentra
dicentra provides sought-after food safety guidance, compliance consulting services and scientific guidance for food and health-related products sold in North American marketplaces. Since 2002, dicentra has been helping clients resolve complex scientific and safety issues, develop safe and effective market-leading products and facilitate timely regulatory approvals. To learn more about dicentra, please visit www.dicentra.com

Click here to view the original article. 






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Business Networking: Tips and Results for Sustainable Growth.

Posted on September 01 2016 | Author: Admin

If you have knowledge, let others light their candles in it.
Margaret Fuller
(1810-1850, Journalist, Critic and Women’s Rights Activist)

Expanding your networks and building strategic partnerships play an integral role in successful and sustainable growth, especially in today’s society. The new economy - also called the digital economy has had, and continues to have, a remarkable impact on businesses and how they are creating awareness amongst others.

Nowadays, growing and maintaining business relationships have become much simpler thanks to technological advancements like cell phones or GoToMeeting and social media platforms such as LinkedIn. Building a network for your business is an important way to leverage different assets, create exposure, and ultimately learn in a mutually beneficial manor.

Pre-Networking
Prior to engaging in networking activities, it’s important to understand your strengths, weaknesses and what you are trying to gain from this experience. For example, if you are excellent at carrying conversations and enjoy large groups of people, consider participating in larger networking events, conferences or trade shows. If you are more the one-on-one type, meeting for coffee or smaller seminars may be more suitable for you to begin.

Take advantage of the different social platforms effectively, and make networking more efficient. For example, webinars are virtual learning sessions you can attend with others on a specific area of interest. These can be useful for a quick lunch-break networking. Another technological advancement that has impacted networking is GoToMeeting or conference programs via the Internet to communicate with people in different cities or even across the world. This makes it easy to decrease travel costs and increase connectivity.

Before choosing your networking event, it’s also important to take into consideration and determine the value in attending. What would you like to gain from this experience? Make new connections? Keep up to date on the latest industry trends? Strengthen existing relationships?

Here are several suggestions to consider, prior to engaging in a networking event:

  1. Research the organizations and key players who are attending. It demonstrates you’re prepared and keen to become connected. This can also help identify shared areas of interest, making it effortless to carry out a conversation. This can be done simply through searching LinkedIn profiles or company websites that contain employee information. After all, the information is there to be read!
  2. Make sure you’ve read about the event and know the details: time, place, what you should bring etc. It’s never a good feeling to be rushed or arrive late.
  3. Be prepared! Bring business cards, company handouts, pens, a notebook, etc. It is strongly recommended to prepare ahead of time, and decrease your chances of forgetting something.
  4. Dress to impress. This is an obvious one however there are always a few people who tend to overlook dress codes. Remember that it’s better to be slightly over dressed than under dressed. To simplify: Style is a way to say who you are without having to speak. –Rachel Zoe
  5. Consider preparing a list of people you’d like to talk to, questions or topics you may wish to discuss or what it is you want to gain from the event.
  6. Don’t go into a conversation expecting something. The best interactions are genuine and on the basis of goodwill. 
  7. Be kind, polite and sincere to everyone because you never know who could be joining in on a conversation or passing by.
  8. Keep an open mind. Opportunities arise quickly and you never know whom you’re going to meet or how you may be able to help one another.
  9. Make sure you’re rested! Sleep is obviously very important.  

Let the Networking Begin
When you’ve reached your networking event, it’s always important to be alert and aware. You don’t want to miss out on any potential opportunities. Keep your goals in mind and if necessary, take frequent breaks to ensure you’re on track.

Try to avoid hesitation when intimidated by someone you wish to speak with. We all can learn from one another so take the opportunity to seek what you are looking for, stay optimistic and keep your head up. Don’t forget to hand out your business cards or information and vice versa. Collecting others information will help with the follow-ups. Go for it and take a few risks! 

Post-Networking
Post-networking is crucial for truly harnessing those relationships. This is the time for follow-ups and next steps. It’s important to make the effort to email or call the connections you’ve made to thank them for their time or ask any additional questions. This can further open the relationship up to future interactions and opportunities for collaboration. Add your new connections on LinkedIn to broaden your network and to stay in touch through a social media platform targeted specifically towards networking!

The benefits from networking are very helpful to sustainably grow your company. These outcomes can benefit you in a range of ways. You could meet investors who show interest in your company, professionals who want to join your team or even gain new clients. You will also continue to grow and learn as an individual. While all of this is happening, you are simultaneously creating exposure and establishing a reputable image for you and your company!

So my advice to you is to keep calm and network on!


Elisha Amar
Corporate Program Assistant


Sources
5 reasons networking is necessary for start-ups
Business quotes for sharing knowledge
Tom Farley networking tips

Photo
Pixabay






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