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SkillsPlus International Inc.
The Leader in Compliance Training: CGMP, QSR and State Licenses
The Leader in Compliance Training: CGMP, QSR and State Licenses

SkillsPlus International Inc.'s posts

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GMP Training Courses - Taught Live At Your Site

We offer live instructor GMP training courses, that are taught at your location. - - Highly respected FDA compliance training - - cGMP QSR GMP - - courses, classes, workshops, and seminars

View our GMP training course offerings:


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Free GMP Tip on Root Cause Analysis

The FDA says, "Human error is not a root cause." If your first reflex is blaming human error, it's time to re-think the situation in order to identify the real root cause of the human error.

There are several categories of human errors: slips, lapses, and induced errors. These can account for a large percentage of errors. In order to understand these human errors in more detail, they can be investigated through the use of investigative tools such as a Walk Through Analysis or Control Barrier Analysis.

Once the underlying contributing factors and real root cause(s) are understood, then they can be controlled (in many cases).

Learn more about this topic by taking this course by SkillsPlus Intl Inc:
Root Cause Analysis for Better Investigations - A cGMP QSR GMP Training Course:

#FDA #cGMP #QSR #GMP #RCA #training #free #tip

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2017 Course Catalog - FDA GMP QSR cGMP - - - SkillsPlus International Inc. is proud to announce our 2017 course catalog. We offer a large variety of FDA cGMP QSR GMP courses, classes, workshops, and seminars. - - - View our 2017 catalog (PDF):

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Advanced cGMP Training Courses

Meet our instructors:

Allan Dewes, M.A.
Allan Dewes, President of SkillsPlus International Inc., possesses over 30 years experience in identifying training needs, and creating and delivering practical, cost-effective training solutions for CGMP, GCP, GLP, QSR, management, and supervisory development. Mr. Dewes facilitates classes for all levels of the organization.

Allan is known for delivering exciting, creative, and participative training sessions. An acknowledged leader in the training field, he has spoken at numerous international conventions. He conducts training in all topics offered, including CGMPs, GLPs, SOPs, Root Cause Analysis, Writing Investigation Reports, Managing for Compliance and many more.

Allan is the author and publisher of the CGMP Challenge, Inspection Detection, the extremely popular CGMP Trainer's Survival Kit II, Instructor Guides CGMP training programs for pharmaceutical and medical device training, and CBT materials to support on line learning.

Prior to working in the pharmaceutical industry, Allan was a staff psychologist. He has worked with a variety of patient populations.

Mr. Dewes earned a Bachelor of Arts in Psychology and Business Administration from Ramapo College of New Jersey, and a Master of Arts in Clinical psychology, from Towson State University. His graduate research study focused on adult learning, behavior change, and communication.

Paula Marks, M.S.
Paula Marks is the CEO and founder of Great Marks Professional Services, LLC. A Quality Assurance professional, Ms. Marks has practical and management experiences in various pharmaceutical, biotechnology, cell-therapy, research and development, and medical device/IVD companies. Paula is a certified training professional with 18 years of experience as a Trainer and Facilitator, and is certified to lead and coach executive professionals in leadership development.

Ms. Marks is a sought after Quality SME and Trainer who is consistently hired to assume key roles related to cGMPs, QSRs, remediation, quality, and compliance deficiencies. She brings a respected ability to interpret FDA Consent Decrees and Warning Letter observations within challenging and difficult manufacturing environments. Her experience on diverse domestic and international teams yields successful outcomes of: removal of Consent Decree statuses, and compliant closure of Warning Letter observations.

Paula's technical expertise includes the: interpretation, administration and set-up of manufacturing operations, quality assurance, quality/compliance systems (specifically, electronic document management systems), deviation and CAPA investigatory activities, aseptic processing, contamination control, regulatory affairs, new product design, and product release testing systems for compliance to regulatory bodies (both domestic and international).

Ms. Marks is a member of the: ISPI (International Society for Performance Improvement), ASQ (American Society for Quality) and the Association for Talent Development (ATD, formerly ASTD). Paula has a B.A. degree in Liberal Arts from the Antioch University, and an M.S. degree in Education from Capella University. She is currently working on her Ph.D. dissertation in Education.

#FDA   #GMP   #cGMP   #training   #courses   #classes   #workshops   #seminars   #QSR   #advanced   #basic  

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cGMP Basics Training - A GMP training course for newbies and seasoned employees #FDA   #cGMP   #GMP   #training   #course   #class   #workshop   #seminar   #live   #onsite  

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CA Designated Representative Training - - On February 20, 2015, the California Board of Pharmacy announced that third-party logistics providers (3PLs) must obtain a #3PL  license, as well as designate a responsible manager, and secure licensure of specialized employees who will serve as designated representatives-3PLs (DR-3PL). - - DR-3PL applicants must provide proof of DR-3PL training. We offer a Designated Representative-3PL training course. Learn more and buy now:

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Florida Certified Designated Representative (CDR) Exam - - - Didn't pass? Getting ready to take the exam? - - -  Take our FL CDR exam preparation course:   #FL   #CDR   #exam  

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Exemptee Training Course and Designated Representative Training Courses for #California   #HMDR   #Exemptee   #Wholesalers   #3PL  and #Florida   #CDR   #exam   - - - Learn more or buy now: 

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ROOT CAUSE ANALYSIS FOR BETTER DEVIATION INVESTIGATIONS: GMP TRAINING - - - One of the top reasons for a company to receive a 483 is a deficiency in the deviation investigation process. In this onsite hands-on workshop, employees learn the most effective tools to determine the real root cause of the problem. Attendees use actual plant deviations to practice the use of the tools. Allan has taught this course all over the world with exceptional results: #FDA   #QSR   #cGMP   #GMP   #training   

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Plan Now For 2016 - Choose SkillsPlus Intl Inc QSR & GMP Training

Book early to reserve your preferred dates.

Select our most popular courses (always customized for you):
GMP/QSR Essentials
Root Cause Analysis for Better Investigations
Writing Deviation Investigation Reports
Advanced Deviation Investigation Facilitation
Deviation Investigation: One-on-One Coaching
Understanding Human Errors
Qualstar: A GMP/QSR Simulation

Start your 2016 training plan & budget:
Call/email us, or visit our website:
Peek at our current course catalog (PDF):

#FDA #QSR #cGMP #GMP #training
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