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Terri Melvin

Introduction to Drug Good Manufacturing Practice (GMP): Meeting FDA Requirements

Event Details

Time: May 12, 2010 to May 13, 2010
Location: Hilton Woodbridge-Iselin, NJ
Website or Map: http://www.enkap.com
Phone: 561-795-2785
Event Type: training, workshop
Organized By: Terri Melvin
Latest Activity: Jan 5

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Event Description

One Comprehensive Workshop - two days

Early Registration Discount: Register by April 1, 2010 and save 10%


May 12-13, 2010 - Hilton Woodbridge/Iselin, New Jersey


Workshop Content

GMP Regulations: An Introduction

Part 210: Importance

Part 211: Subpart B - Personnel

Part 211: Subpart C - Buildings and Facilities

Part 211: Subpart D - Equipment

Part 211: Subpart E - Control of Components and Drug Product Containers and Closures

Part 211: Subpart F - Production and Process Control

Part 211: Subpart G - Packaging and Labeling

Part 211: Subpart H - Holding and Distribution

Part 211: Subpart K - Returned and Salvaged Products

Part 211: Subpart I - Laboratory Controls

Part 211: Subpart J - Records and Reports


"Hand's on" APPLICATION EXERCISES

Outline a training program that FDA determines to be acceptable

Develop a cleaning procedure for a facility

Develop a cleaning and maintenance procedure for a major piece of manufacturing equipment

A tablet blend has to be reprocessed. Learners will  devise a solution

Develop a plan for salvaging a rare and expensive antibiotic from a facility that has been flooded


Click Here To View Workshop Brochure and Registration Form

Click Here to Register in The enKap Store

Comment Wall

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

  • Unmesh Mether
  • Suzanne Carlson
  • Ashokkumar.perumalla
  • Glenn Melvin
  • Frank Pokrop
  • Ambra Roby

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