Auditing
| The Art of GMP Auditing |
$19.95 plus tax and shipping
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How to implement, maintain, and
improve an effective compliance auditing program; tips for success from
peers and industry experts. |
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Change
Control
| Passionate About Change Control |
$19.95 plus tax and shipping
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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. |
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Compliance
When Things Go Wrong, Part
I:
The Consequences of Noncompliance |
$19.95 plus tax and shipping
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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. |
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When Things Go Wrong, Part II:
Encouragement for Tough Times |
$19.95 plus tax and shipping
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Practical, common sense tips on what
you can do when you join a department or an organization which is
noncompliant. |
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| 30 Tips to Bring You Closer to
Compliance |
$19.95 plus tax and shipping
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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. |
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| On Compliance Leadership |
$19.95 plus tax and shipping
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Characteristics or traits of
excellent compliance professionals and executives; “what it takes” to
be an excellent compliance officer or leader. |
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Documentation
| Beating the Documentation
Blues |
$19.95 plus tax and shipping
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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. |
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| Documentation Revisited |
$19.95 plus tax and shipping
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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. |
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Part
11
| On Complying with 21 CFR Part 11 |
$19.95 plus tax and shipping
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Practical tips for implementing the
rule and ensuring compliance in your facility, including an
implementation checklist. |
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| Electronic Records: An
Update |
$19.95 plus tax and shipping
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Highlights of the rule explained in
plain English, including the key points of FDA enforcement policy
(Compliance Policy Guide). |
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Environmental Monitoring
| Environmental Monitoring and
Other Facts of Life |
$19.95 plus tax and shipping
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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. |
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European
Union
| Meeting Requirements of the
European Union |
$19.95 plus tax and shipping
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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. |
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Goal
Setting
| New Beginnings |
$19.95 plus tax and shipping
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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. |
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Good Laboratory Practices
(GLPs)
| The Forgotten GLPs |
$19.95 plus tax and shipping
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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." |
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Good Manufacturing
Practices (GMPs)
| A Brief History of the
GMPs: The Power of Storytelling |
$19.95 plus tax and shipping
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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. |
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Leadership
| Changing Times, Changing Ideas |
$19.95 plus tax and shipping
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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. |
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| How You Can Use Everything You
Make |
$19.95 plus tax and shipping
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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. |
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Inspection
Preparation
| Preparing for a Major
Inspection |
$19.95 plus tax and shipping
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How to prepare for a major
preapproval, prelicensing, or routine inspection, including project
management tips. |
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Problem Investigations
On Problem Investigations, Part
I
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$19.95 plus tax and shipping
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When to investigate, root cause
analysis basics, required timeliness of investigations, and ideas for
your SOPs.
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On Problem Investigations, Part
II
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$19.95 plus tax and shipping
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Specific tools on how to analyze,
research, and document a problem investigation.
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Quality Assurance/Quality
Control
| Step Up to the Responsibility
of QA and QC |
$19.95 plus tax and shipping
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Responsibilities of quality
assurance, including tips on managing and reporting a product recall,
and on making batch disposition decisions. |
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Training
| Improving Your Training
Program |
$19.95 plus tax and shipping
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How to set up, implement, or improve
an effective GMP, job-skill,
and compliance training program. |
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| 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. |
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| “The Play’s The Thing” |
$19.95 plus tax and shipping
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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). |
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| Excellent Training Begins with
Training That Counts |
$19.95 plus tax and shipping
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Training class ideas from peers and
industry experts, including specific, immediately usable ideas, and
resources for compliance trainers. |
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| Marketing 101 for Trainers and
Other Smart People |
$19.95 plus tax and shipping
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How to assess training needs, develop
on-target training, and “market” training classes inside your company. |
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Working
Relationships
| Reflections in the Mirror, Part
I: Working with
Contractors |
$19.95 plus tax and shipping
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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. |
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| Reflections in the Mirror, Part
II: Working with Clients |
$19.95 plus tax and shipping
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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." |
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| Working with Contractors and
Consultants |
$19.95 plus tax and shipping
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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. |
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| Working with FDA |
$19.95 plus tax and shipping
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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. |
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| Working with Teams |
$19.95 plus tax and shipping
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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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Thank you for your order. We appreciate
your business.
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