Friday, December 19, 2008

101 Ways to Make Meetings Active or Good Pharmaceutical Manufacturing Practice

101 Ways to Make Meetings Active: Surefire Ideas to Engage Your Group

Author: Mel Silberman

Say goodbye to the dull and deadly! Siberman's back--and better than ever!

Think about your last meeting. Was it boring? Meetings often are. You might be yawning just thinking about it. You're not the only one!

Those who attAnd stale meetings are as bored with them as the people responsible for running them. "Dull and deadly" is never the way to get things done. In his latest book, active training specialist Mel Silberman packs 101 tools, tips, and techniques guaranteed to brighten your next meeting. You'll move the action along while successfully fulfilling genuine business goals and objectives. This is a resource for everyone!

"Mel has done it again! Use just a few of the more than 200 ideas in this gem of a book and never again will you hear 'ugh, another meeting.'"--Glenn M. Parker, team building consultant; author, Team Players and Teamwork; co-author, Teamwork and Teamplay

    You'll get the basics on:
  • Preparing a meeting
  • Engaging participants right away
  • Stimulating discussion
  • Prompting creative problem solving
  • Managing conflict
  • Building consensus
  • Creating an unforgettable closing . . . and much more!
Silberman has drawn a few choice tips from his other resources, but most of 101 Ways to Make Meetings Active consists of all-new, powerful techniques for pumping energy into your business gatherings. Your meetings and presentations will be more fun than ever before--and you'll also build a stronger, more collaborative sense of mission and purpose.

Stop yawning! No need to be bored when Silberman's on the scene.A special BONUS is the "nuts and bolts" section that contains 140 field-tested facilitationtips!



See also: California Pizza Kitchen Pasta Salads Soups And Sides or Salsas That Cook

Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

Author: John Sharp

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.

Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices.

This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

Doody Review Services

Reviewer: Thomas L. Pazdernik, PhD (University of Kansas Medical Center)
Description: This is how-to-do-it manual brings together important information from more than 20 different worldwide official regulatory documents on good pharmaceutical manufacturing practice.
Purpose: The purpose of this offering is to bring together in one source the most important information referred to as regulations, guides, or guidelines from over 20 documents. It draws most heavily from two very important resources available in the public domain: The United States Current Good Manufacturing Practice Regulations (cGMPs) and the European Commission's Good Manufacturing Practices for Medicinal Products for Human and Veterinary Use (the EC GMP Guide). The author does an excellent job in meeting this goal.
Audience: This book is a very important addition to the personal library of anyone who is involved in the regulatory process for pharmaceutical products.
Features: The first chapter compares and contrasts the principles and rationales of Good Manufacturing Practice (GMP), drawing most extensively from the U.S. cGMPs and EC GMP Guide. This is followed by several chapters dealing with personnel, facilities, contamination control, equipment, materials, production, packaging and labeling, holding and distribution, laboratory controls, records and reports, and how to deal with returned products issues. There is a chapter devoted to the basic principles of manufacturing sterile products followed by a chapter on GMP and quality assurance in their manufacturing. There are separate chapters dealing with validation of both the general principles as well as the applications of good manufacturing practice. The last chapter provides a concluding comparison of the U.S. cGMPs and the EC GMP Guide.
Assessment: I strongly recommend this book as a must resource for anyone involved in good pharmaceutical manufacturing practice of products for the international market.

Rating

3 Stars from Doody




Table of Contents:
Ch. 1Introduction : status and applicability of US regulations/EU guidelines - general quality issues1
Ch. 2Personnel, organization, and training19
Ch. 3Premises/buildings and facilities59
Ch. 4Contamination and contamination control85
Ch. 5Equipment99
Ch. 6Materials control113
Ch. 7Production and process controls149
Ch. 8Packaging and labeling control171
Ch. 9Holding and distribution191
Ch. 10Laboratory controls211
Ch. 11Records and reports253
Ch. 12Returned and salvaged drug products325
Ch. 13Sterile products manufacture - basic principles329
Ch. 14GMP and quality assurance in sterile products manufacture371
Ch. 15Validation - general principles405
Ch. 16Validation - applications439
Ch. 17Self-inspection and quality audit469
Ch. 18US cGMPs and EC GMP guide - concluding comparison485

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