The Art of GMP Auditing
$19.95 plus tax and shipping

How to implement, maintain, and improve an effective compliance auditing program; tips for success from peers and industry experts.
Change Control
Passionate About Change Control
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How to set up, implement or improve a change control system.  Covers changes to facilities, utilities, equipment, computers and the manufacturing process.
When Things Go Wrong, Part I: 
The Consequences of Noncompliance
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Consequences of noncompliance with U.S. regulations, including warning letters, product seizures, consent decrees of permanent injunction, and civil money penalties.
When Things Go Wrong, Part II:
Encouragement for Tough Times
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Practical, common sense tips on what you can do when you join a department or an organization which is noncompliant.
30 Tips to Bring You Closer to Compliance
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Thirty of the most common GMP pitfalls and how to avoid them from industry professionals, supervisors, and managers.  This article is one of our customers' favorites. 
On Compliance Leadership 
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Characteristics or traits of excellent compliance professionals and executives; “what it takes” to be an excellent compliance officer or leader.
Beating the Documentation Blues 
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Advanced tips on improving your controlled documentation system, including key points to teach employees and a partial list of SOPs needed to operate a GMP manufacturing facility.
Documentation Revisited
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How to set up, implement, or improve a controlled documentation system and department, with practical tips from experienced document managers, professionals, and industry experts.
Part 11
On Complying with 21 CFR Part 11
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Practical tips for implementing the rule and ensuring compliance in your facility, including an implementation checklist.
Electronic Records:  An Update
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Highlights of the rule explained in plain English, including the key points of FDA enforcement policy (Compliance Policy Guide).
Environmental Monitoring
Environmental Monitoring and Other Facts of Life
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Environmental monitoring (EM) from a QA perspective, including reviewing EM data, performing batch disposition, ensuring good training and documentation, and working with contract manufacturers.
European Union
Meeting Requirements of the European Union
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Basic European Union (EU) GMP requirements, including product registration, batch release, and what to expect during inspections made by inspectors from EU regulatory agencies.
Goal Setting
New Beginnings
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Common-sense tips on goal-setting and continuous improvement, including common GMP pitfalls, and having the courage, persistence, and perspective to implement improvements within an organization.
Good Laboratory Practices (GLPs)
The Forgotten GLPs
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A brief survey of worldwide GLP regulations and some tips for handling common problems associated with meeting them, including "Twenty-five laboratory notebook tips."
Good Manufacturing Practices (GMPs)
A Brief History of the GMPs:  The Power of Storytelling
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The tragedies that led to the creation of U.S. good manufacturing practices and GMP history from the early 1900s to the present.  This is one of our customers' favorite reprints.
Changing Times, Changing Ideas
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Serious issues in our industry affecting GMP compliance, including the lack of planning, inequities in pay and opportunity, using layoffs too easily, and an unwillingness to accept responsibility and stand up. 
How You Can Use Everything You Make
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Common sense GMP tips, including using only released raw materials, reviewing data quickly, performng necessary validations, implementing change control, and successfully managing or leading a group.
Inspection Preparation
Preparing for a Major Inspection 
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How to prepare for a major preapproval, prelicensing, or routine inspection, including project management tips.
Problem Investigations
On Problem Investigations, Part I
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When to investigate, root cause analysis basics, required timeliness of investigations, and ideas for your SOPs.

On Problem Investigations, Part II
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Specific tools on how to analyze, research, and document a problem investigation.

Quality Assurance/Quality Control
Step Up to the Responsibility of QA and QC
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Responsibilities of quality assurance, including tips on managing and reporting a product recall, and on making batch disposition decisions.
Improving Your Training Program 
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How to set up, implement, or improve an effective GMP, job-skill, and compliance training program.
The Essence of Training
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What constitutes good training, problematic attitudes, and how skills, knowledge, and infrastructure will be the only way companies compete.
“The Play’s The Thing”
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Skits on inspection preparation, change control, and design control
(One of the skits was recently selected for inclusion by the World Health Organization in their world GMP training materials).

Excellent Training Begins with Training That Counts
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Training class ideas from peers and industry experts, including specific, immediately usable ideas, and resources for compliance trainers.
Marketing 101 for Trainers and Other Smart People
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How to assess training needs, develop on-target training, and “market” training classes inside your company.
Working Relationships
Reflections in the Mirror, Part I:  Working with Contractors
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Detailed information on working with consultants and contractors (firms doing manufacturing, packaging, or testing), including selection, the writtten contract, required documentation, and problem notification. 
Reflections in the Mirror, Part II: Working with Clients
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Practical tips for contractors or third-party firms on working with their clients and training their employees on how to work with customers, including the "Don's and Don'ts."
Working with Contractors and Consultants 
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Tips for establishing and maintaining good working relationships with your contractors, consultants and temporary help in a GMP environment, including selection, training, monitoring, records and change control.
Working with FDA
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Practical, common sense tips on working with U.S. Food and Drug Administration investigators during an inspection and on building an on-going, good working relationship.
Working with Teams
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Practical tips on working with or leading teams inside organizations, including “allowing the leadership to pass,” ensuring diversity, and respecting individuals and their contributions.

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