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.

The Device History Record (DHR)

The Device History Record (DHR)

The US FDA states the following:

Each manufacturer should maintain DHR’s. For what steps in the manufacturing process are these records to be maintained? It is for establishing and maintaining procedures to ensure that DHR’s for each batch, lot, or unit. The purpose of this requirement is to show that the medical device is manufactured exactly as mentioned in the DMR and that the requirements are met. The FDA states that the DHR shall have in it, or will refer to where it locates these bits of information:

  • the manufacturedates
  • the manufacturedquantity
  • how much quantity was released for distribution
  • records showing acceptance that the device is manufactured in accordance with the DMR
  • the product’s primary identification label and labeling that went into each production unit; and
  • detail of all and any device identification(s) and control number(s) used in the manufacture of the device.

Important facts to remember about the DHR

It is not mandatory to keep the original DHR with the device. It is possible that due to frequent testing and other tasks carried out; the DHR can get tampered. However, before any DHR is removed, there should be a sound set of controls to retain or retrieve data. It should be kept intact, so that there is no loss of record. An authentic way of ensuring this is by having a person in the organization in charge of this aspect. That person can scan the DHR and store it into a repository.

A device that goes into distribution with a DHR is as considered a spurious one. Anyone responsible for doing this is liable for a year’s imprisonment or a penalty of up to $1000.

The manufacturer should ensure clarity on whether the product has an original DHR or the record of a rework. Rework in this case refers to the changes done on a nonconforming product to meet regulatory requirements.

On the other hand, alteration is the repair or servicing carried out on a product that has already entered distribution.

Finally, remanufacturing is the process carried out on a conforming product to make it nonconforming. Also included under this is anything that is done to the device to alter its characteristics. All these three types of work on the device should be recorded in the DHR and maintained.

References:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.184

http://www.mddionline.com/article/clarifying-device-history-record-issues

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Is a completeDevice History Record a must?

Is a completeDevice History Record a must?

This is the same as asking if a teacher needs to complete her entire syllabus for the class. There is considerable debate in the medical devices industry circles about whether some portions of a DHR can be done away with.

Please, please, do not take the DHR for granted. Of course, if inviting a recall is on top of your mind, go ahead and skip any of these steps:

1. The exact date of manufacture of your device, batch, or lot;

2. The precise numbers of the devices you manufactured;

3. Out of these, the actual number that was accepted and taken up for distribution;

4. Most important: All records that show that your support devices are being manufactured as specified in the DMR;

5. Another very important one: Make sure you have included a copy of the ACTUAL product label consisting of carton and/or pouch, along with the product’s Directions for Use;

6. Whatever extracontrol numbers, identification, or serial thatyou may have included.

So, why miss out on any critical information? Just make sure that all these are retained in your DHR. Never ever forget this: You are safe when you document. It is not only your best protection against errors in the process which you can identify at that exact stage and set right at the exact place; it also makes sure FDA cannot catch you by the scruff of your neck. What greater defense to show the FDA than your actual documented records? The FDA is there to check your compliance with QSR, and let us make it easy for them.

http://www.medicaldevicesummit.com/Main/Blogs/57.aspx

 

Contact Detail

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801