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Glenn Melvin GLP Real-Life Training PowerPoint…

Celeste Rose is excited. As a GLP Subject Matter Expert and instructor for our upcoming GLP LIVE Training Workshops - (click here for complete brochure) in San Diego and San Francisco March 9-12th, attendees from Genentech, Abbott Vascular, Ciba Vision, The Clorox Company, BioMarin Bioanalytical, Edwards Lifesciences, and other major manufacturers will listen to her discuss the fundamentals of effective

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Added by Glenn Melvin on February 26, 2010 at 10:00am — No Comments

Glenn Melvin It’s What You Know and How You Network

Back when I owned the Institute of Validation Technology, I had numerous industry professionals serve as our company’s subject matter experts. They showcased their talents and demonstrated their expertise by presenting at our conferences and writing articles in our journals. They informed our audience and readership of industry professionals on numerous validation and GMP FDA compliance topics, and many times were rewarded by either performing lucrative consulting duties at client sites or mo

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Added by Glenn Melvin on February 16, 2010 at 9:19am — No Comments

Glenn Melvin Getting Your PI More Involved

I recently posted a discussion on our linkedin CONTENT groups for industry professionals who may be interested in participating as enKap instructors for upcoming GCP training workshops we are developing. I received a number of responses, including Charles Pierce of CTI Clinical Trial and Consulting Services.

Reading his linkedin profile, I was struck (awed actually) by the fact that Charles was both an M.D. and a Ph.D. (How many people in the world have these combination of degrees?)

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Added by Glenn Melvin on February 9, 2010 at 9:29am — No Comments

Glenn Melvin Thought on Effective Training


Back in the day, growing up, I had a remarkably undistinguished academic career. This was due to many reasons, certainly lack of interest was a huge contributing factor, but I somehow managed to graduate from the finest schools in the State of Connecticut.

As I look back on my school days, I clearly suffered from “death by lecture” syndrome. The Talking Heads (a motley bunch) would drone on hour by endless hour on mostly subjects that I knew then I would never use in the “real wor

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Added by Glenn Melvin on February 5, 2010 at 10:30am — No Comments

Nizar AYED Workflow: The way things go

Workflow

Nowadays, workflows are wide spread in the business world. The desire to streamline operations in any business sector and benefit from a standard approach has allowed this concept to develop and integrate components almost inevitable to the information

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Added by Nizar AYED on January 5, 2010 at 12:46pm — No Comments

John Adair QA Ownership of SOPs in a GLP compliant system

Has anyone heard of a GLP requirement that restricts the QAU (Quality Assurance Unit) from being the owner of any SOP in the document control system? I'm being told by some that the FDA (only in GLP environment) will "write us up" if we allow QA to own SOPs. By this I mean that QA has SOPs that they are responsible for in our 2 year review process. Continue

Added by John Adair on December 13, 2009 at 2:28pm — No Comments

Rich Antonaccio Guidelines for CAPA Scoping

by William McQuillan, Jr CAPA Subject Matter Expert

Many organizations are diligent in identifying inputs to CAPAs and in meeting to review and approve the opening of a CAPA file. During the review process for opening a CAPA, it is important to evaluate the scope of the CAPA, if known. This activity is com

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Added by Rich Antonaccio on November 12, 2009 at 2:00pm — No Comments

Rich Antonaccio When does an organization need to open a CAPA? (Identifying and Measuring Inputs to CAPA)

by: William McQuillan Jr. CAPA Subject Matter Expert


Many organizations and training programs interpret CFR 820 Subpart J and emphasize having appropriate inputs to facilitate knowing when to open a CAPA by “analyzing processes, work operations, concessions, quality audit reports, quality rec

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Added by Rich Antonaccio on October 12, 2009 at 1:00pm — No Comments

Sophia Training in an API plant

FDA is emphasising on training needs. Once the API starting material is introduced into the API process, GMP controls are increased according to some reasonable and scientifically sound rational as processing proceeds from early process steps to final synthesis, isolation and purification steps. Of course, the degree of control depends on the process and manufacturing stage. And in the same way it goes for training too. In the initial steps if the training is not very detailed the effects in cas… Continue

Added by Sophia on September 9, 2009 at 1:23am — No Comments

enKap Expanding our Learning Community on LinkedIn

enKap is proud to announce that we have started two groups on linkedin. GMP Training CONTENT and Computer Validation CONTENT–why? We’ve been active on linkedin.for about five weeks now, and during th

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Added by enKap on June 16, 2009 at 3:59pm — No Comments

enKap Global Harmonization Task Force (GHTF): CAPA Guidance Coming

For those of you who may not be aware, the Global Harmonization Task Force (GHTF)) offers many useful complimentary compliance guidance documents online on their website.

The GHTF was formed in 1992 in an effort to respond to the growing nee

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Added by enKap on April 7, 2009 at 3:06pm — 1 Comment

enKap Accept or Reject? Enforcement of enKap’s Exclusive Learning Community

Over the past 10 days, since our company’s launch, we’ve had a number of quality professionals from pharmaceutical and medical device manufacturers provide profiles, and be accepted into enKap’s growing learning community. We take your participation as a confident vote that we will provid

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Added by enKap on March 20, 2009 at 1:04pm — 1 Comment

enKap The Beginning: Live from the Company Launch

We looked around the room at each other and I repeated the word enKap to myself. Yes enKap. I was quite certain. enKap? What? The word went round and round in my mind. What was I considering? The name seemed so foreign to me.

Many company names in our industry included institution

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Added by enKap on March 9, 2009 at 6:30am — No Comments

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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


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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

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