enKap community

Engaged. Knowledge. Application

What is enKap?

enKap. enKap? Engaged knowledge application. Something different. Something new. Something innovative. You are correct. We are different.


At enKap, we are creating an exclusive learning community for professionals in FDA-regulated industry. We’re not new at creating learning communities in this industry. We’ve done this before. We created the Institute of Validation Technology, an information provider for validation professionals. We created and published the Journal of Validation Technology and the Journal of GMP Compliance. Our Conference Division hosted conferences on GMP and validation topics in Europe and the United States. We sold the company in March, 2004.


Training:

We see a need to bring back passion and fun to training. Our goal for our world-class instructors (from top pharmaceutical and device firms) is to consistently deliver information through creative and innovative training methods which engage learners, challenges them, and gives them the foundation to strategically apply their new knowledge to their job responsibilities.

We are proponents of active learning; that is, learning by doing. Learners participating in collaborative instructional activities, working together to devise solutions to real-life problems.


Website:

Our website is a community content destination; that is constantly evolving by nature. Content is first and foremost. There are opportunities for you to interact with fellow professionals, give your opinion, share expertise and gather information on FDA enforcement strategy, and much more.


Publications and Other Training Products:

Our FDA Compliance Journal and other training products will be an invaluable addition to your regulatory compliance library. In the near future, you will see product introductions in the Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) areas.


Together, our learning community can become a great foundation of knowledge the next generation of industry professionals can utilize as an educational resource. Your continued involvement, giving back, participating, sharing your information needs and expertise ensures this goal is possible.

We've got it all right here...see even more about enKap

See ABOUT US in a different way...click here

enKap gives back. A percentage of every purchase goes to the Heath Evans Foundation

enKap has named the Heath Evans Foundation as the institute's official corporate charity. Glenn and Terri Melvin, founders of enKap and long-time supporters of the Foundation, are excited about using their business to bless the foundation financially and to provide exposure within the pharmaceutical industry that they serve. "We cannot think of a more deserving cause to support with enKap," says Glenn. "Our corporate mantra is to give back as we serve our clients, and Heath's passion for eradicating sexual abuse and fostering hope and healing to victims is something we have thrown our personal, and now corporate, support behind," adds Terri.

Complete Event Schedule

Join the U.S. FDA and Major Pharma and Device Manufacturers who attend our events; Pfizer, Merck, Johnson & Johnson, AstraZeneca, Medtronic, Boston Scientific, Alcon, Schering-Plough, Roche, Bristol Myers Squibb, Becton Dickinson and more...


***SCHEDULE***


GLP LIVE Training Workshops - (click here for complete brochure)

Two GLP Workshops in Two Locations

1. The Brass Tacks of GLP: Practical Understanding of the Fundamentals As Never Before Explained

2. Writing Effective GLP Docments

March 9-10, 2010 San Diego

March 11-12, 2010 San Francisco by a GLP Subject Matter Expert


Medical Device Software Validation LIVE Training Workshops - (click here for complete brochure)

Two Workshops in Two Locations

1. Medical Device Software Validation: System Definition and Requirements: Incorporating Effectiveness and Compliance in Software Design

2. Implementing Critical Processes for Effectively Supporting Medical Device Software Validation Programs

March 24-25, 2010 Iselin, NJ

May 19-20, 2010 Waltham, MA by Boston Scientific


CAPA LIVE Training Workshops - (click here for complete brochure)

Two Workshops

1. CAPA: Effective System Management - One Industry Professional Shares His Expertise

2.Supplier-Related CAPA: Conducting Effective Root Cause Investigations

April 20-21, 2010 Boston/Waltham, MA

by a CAPA Subject Matter Expert


GMP LIVE Training Workshop: Master Production Batch Records - (click here for complete brochure)

Effective Generation and Control of Master Production Batch Records (MPBR)

April 22, 2010 Boston/Waltham, MA by a GMP Subject Matter Expert



GMP LIVE Training Workshop: Introduction to Drug Good Manufacturing Practice (GMP): Meeting FDA Requirements - (click here for complete brochure)

May 12-13, 2010 Hilton Woodbridge-Iselin, NJ by a GMP Subject Matter Expert


To View Previously Recorded Webinars Click Here


Special 21 CFR Part 11 Recording Package - Click Here for More Details


Recent Webinar TESTIMONIALS:

"It was the perfect presentation for my audience. Over the last year, since I started retraining all my frequent fliers, I have gone over or flagged for action every concern in that presentation. I had people in the audience that needed a final re-enforcement. I believe every "hot-topic" in Change Control was covered". - Anuja Rajbhandari, Change Control Specialist - AstraZeneca - CLICK HERE TO VIEW THE WEBINAR ON CHANGE CONTROL

"Enjoyed it. It was like the trainer has worked at our facility!!" - Carol S. Spicer, Director, Quality, Training and Support Services - Bridge Laboratories - CLICK HERE TO VIEW THE WEBINAR ON GLP DEVIATIONS


Contact enKap

U.S. Toll Free: 877-823-4GXP

Outside the U.S. +1-561-795-2785

Fax: +1-561-798-8138

e-mail: info@enkap.com

1480 Royal Palm Beach Blvd.,Suite A, Royal Palm Beach, FL 33411, U.S.

Members

  • Jerome Council
  • Heather martinez
  • serhan nasırlı
  • Debo Shokunbi
  • Glenn Melvin
  • Ashokkumar.perumalla

enKap Terms and Conditions


enKap Terms and Conditions

All sales are final

Legal Disclaimer

This product and any of its enclosures, attachments or appendices, references to online information, conferences or preparations of materials in a variety of formats are created to provide you with accurate and authorative information concerning the subject matter covered. However, this product and any other ancillary items disseminated in connec-
tion with same are not necessarily prepared by a person licensed to practice law in a particular jurisdiction.
enKap, Inc. is not engaged in rendering legal advice, and this product is not a substitute for the advice of an attorney. If you require legal or other expert advice, you should seek
the services of a competent attorney or other professional.
enKap, Inc. necessarily is not, cannot and will not be liable for any claims, damages, or regulatory legal proceedings initiated as a consequence of you, the customer, modifying,
altering, adding to or deleting portions of any product initially provided by enKap, Inc.
Once any original document provided by enKap, Inc. to you, whether in print or electronic format, has been manipulated or customized by you, then the responsibility for the
document’s accuracy, correctness, and compliance are solely yours.
If any action, claim for damages, or regulatory proceedings is commenced against enKap, Inc. as a consequence of your alteration or modification, etc. of the document templates
or other originally provided materials, then and in that event, you agree to indemnify enKap, Inc. for such claims, and for any attorney’s fees expended by enKap, Inc. in connec-
tion with defense of same.


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