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SkillsPlus International Inc. has been a leader in on-site compliance training for
years. The training staff at SkillsPlus possess expertise in training Good
Manufacturing Practice Regulations (cGMP) and Quality System Regulations (QSR).
Additionally, the team possesses experience
in teaching root cause analysis for investigations, writing deviation
investigations, writing procedures, and a wide variety of
other cGMP and QSR related topics including executive level compliance
training and management skills training. SkillsPlus is the leader in
focused training resources including computer-based training movies,
interactive CBT training modules, and plug-ins for Learning Management
Systems (LMS). Our plug-ins are AICC and SCORM compliant. SkillsPlus also
provides learning resources such as cGMP Challenge Lite
and Inspection Detection Lite. All designed to create competitive, playful and
effective educational environments. SkillsPlus also provides
consulting in cGMP compliance, QSR compliance, and Quality Systems including,
deviations, investigations, investigation
reports, procedure systems development, writing procedures and training system
Allan Dewes, President of SkillsPlus International Inc., possesses over
25 years of experience in identifying training needs. He creates and
delivers practical, cost-effective training solutions for GMP, GCP, GLP,
QSR, management, and supervisory development and facilitates
classes for all levels of the organization. Known for delivering exciting, creative, and highly
interactive training sessions, Mr. Dewes is an acknowledged leader in the training
field and has
spoken at numerous international conventions. Mr. Dewes is the author and publisher of the GMP and QSR Instructor
Guides, the GMP Supervisory Training
Talks, the extremely popular GMP Trainer's Survival Kit, and many more GMP
training resources for various applications. 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 study
focused on adult learning, behavior change, and communication. SkillsPlus International Inc. works with a team of training and
compliance consultants to provide you with current and up-to-date
information. Call today to discuss your training and compliance
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.
Semantic Site Map
> Search our site
> Site map by alphabetical topics
- a listing of our products and services
> On-Site Classes -
taught at your location
> GMP Basics
for Medical Devices
for CGMP and Biotech Manufacturers - challenging activities
for Medical Device Manufacturers - energizing activities
Simulation - an advanced CGMP/QSR course
Cause Analysis for Better Investigations - solve problems and
Errors - Overcoming The Challenges - tackle human errors as a
cause of deviations
Investigation Reports - how to collect data, and write
> Risk Assessment: CGMP/QSR for the 21St Century
- design and conduct an FMEA
> Quality Documentation
Writing for Greater Process Control
Internal and External Customers and Suppliers
> Faster Product Release Through Efficient Batch Record Review
an FDA Inspection
for Swift and Aggressive Regulatory Enforcement
Session - What Leadership Needs to Know
Session - What Every Manager Needs to Know
> Creating CGMP and QSR Responsibility and Accountability
> Trainer Skills
> GMP Trainer Certification
- On-site cGMP training for trainers - Drug & Device
> ISO 17025: Calibration Laboratories
- details ISO 17025 for calibration laboratories
> California Exemptee HMDR and DME Providers Certification Course -
New - iPad ready!
> California Designated Representative Certification Course
- New - iPad ready!
> California Designated
Representative-3PL Certification Course - New
> Florida Designated Representative Study Course
Courses - online internet-based CBT courses
Procedures: for Drug and Device Wholesalers and HMDR
> Free Tips - Free CGMP Training Ideas, Tips and Other CGMP Related Stuff
CFRs - a listing of these federal regulations
- a collection of free tip articles
All E-Learning Is The Same - select training that is pure,
safe, and effective
> About Us
- in the form of subcontracting opportunities
- some of our clients around the world
Us - Some of our personal background.
- Articles of interest to GMP trainers.
Representative and Exemptee Blog
Board of Pharmacy - Information about the Designated Representative
Designated Representative-3PL Certification Course - New
- A partial list of our clients and customers.
Us - How to contact us.
Support for Designated Representative Certification Online CBT Classes
Support for Exemptee Certification Online CBT Classes
Support for GMP Online CBT Classes Classes
of Health Services - Information about the Exemptee certification class.
Representative - Information about the California Designated Representative certification
class. Florida students click here.
Representative-3PL Certification Course - New
- Subcontract employment opportunities.
- Information about the Exemptee certification class.
and Designated Representative Blog
Tips - A free tips page for customers and visitors. Free upgrade areas are
restricted to customers only.
Designated Representative - This is a self study preparation class for the
Florida Designated Representative exam. California
students click here.
Essentials - This on-site class covers basic CGMP information.
GMP Trainer Certification -
On-site cGMP training for trainers - Drug & Device
Train the Trainer - An on-site class training others how to
deliver training in
- News about our company, products and services.
Site Classes - Classes that can be conducted at your site.
- Basic search feature to explore our website
to Free Previews - Call to be enrolled in the latest preview. Preview
request number: 415.948.5220.
Support - A knowledge base answering many questions about CBT or e-learning programs, and
on line learning management system.
Services - The services that we offer.
Procedures: Drug Wholesalers and Home Medical Device Retailers