SkillsPlus International Inc - Compliance Training Experts GMP QSR Designated Representative and Exemptees

The Leader in Compliance Training: CGMP, QSR and State Licenses

Quick Click Links	Express	Description: What you will find
Drug and Device Courses	Most Popular All Courses Coaching	Explore courses that the SkillsPlus team can teach at your site. Keep in mind each outline is only an illustration of a possible course. We always tailor our courses to suit your site's learning needs and environment. We also offer individual and small group coaching on specific quality system requirements.
CGMP and QSR Trainer Certification	Information Registration	Learn to train CGMPs and QSR courses from successful compliance professionals. Experience, practice and master the skills to make compliance training fun, information and exciting.
Drug and Device Trainer Resources	Development Teaching Aids Posters	Explore training resources that can assist in the development of many different CGMP or QSR courses. Here you will find instructor guides, learning aids and posters.
Drug and Device CBT E-learning and Online Courses	Modules	Explore online, CBT or e-learning modules to provide training through classroom digital movies, interactive e-learning programs and AICC or SCORM compliant Learning Management System courses.
California Designated Representative Certification	Buy Now Sign In Support	Drug wholesalers doing business in California or shipping drug products into California need this certification. State Approved.
California Exemptee Certification	Buy Now Sign In Support	Home Medical Device Retailers (HMDR) or Durable Medical Equipment (DME) wholesalers doing business in California or shipping drug products into California need this certification. State Approved.
Florida Designated Representative Certification	Buy Now Sign In Support	Drug wholesalers doing business in Florida or shipping drug products into Florida need this exam preparation course.
For a prompt reply to requests and questions: 415.487.3500 \| allan.dewes@skillsplusinc.com \| Fax: 415.487.1926

Detailed Course Descriptions: Click to examine a course

Auditing: Internal and External Customers and Suppliers Essentials for Pharmaceuticals Qualstar Medical Device Simulation (QSR)

Faster Product Release Through Efficient Batch Record Review Executive Session: What Leadership Needs to Know Qualstar Pharmaceutical Simulation (CGMP)

Creating CGMP Responsibility and Accountability Human Errors: Overcoming the Challenges Risk Assessment: CGMP/QSR for the 21^St Century

Creating QSR Responsibility and Accountability ISO: 17025 Calibration Labs Surviving an FDA Inspection

Critical Thinking in a Regulatory Environment Management Sessions: What Every Manager Needs to Know Technical Trainer Certification: A Technical Trainer Readiness Course

Deviation Investigations: Root Cause Analysis Meetings for Swift and Aggressive FDA Enforcement Trainer Certification: A CGMP QSR Trainer Readiness Course

Deviation Investigations Report Writing Olympics CGMP: Advanced Course Trainer Certification: A QSR Trainer Readiness Course

Essentials for Dietary Supplements Olympics QSR: Advanced Course CGMP: Grab and Gab Series

Essentials for Foods Procedure Writing for Greater Process Controls QSR: Grab and Gab Series

Essentials for Medical Devices Don't see a class. Call us and ask!

Coaching: Call to learn more 415.487.3500

Root Cause Analysis Team Coaching Deviation Report 1:1 Coaching Procedure Writing Coaching

E-learning Modules / CBT / Online

21CFR211: Pure, Safe and Effective Equipment CGMPs Overcoming the Documentation Nightmare Understanding Validation

21CFR820: Essential Elements Failure Mode Effects Analysis (FMEA) Production and Process Controls Writing Procedures: Drug and Device Wholesalers, DME and HMDR

Buildings and Facilities Materials and CGMPs Root Cause Analysis

Contamination Control Organization and Personnel Surviving an FDA Inspection

Teaching Aids
CGMP Challenge	Challenge students knowledge of the content covered in your class. The challenge is designed for from 1 to 5 teams to compete in a friendly way around a variety of CGMP topics. A great teaching tool on a tight budget. Order form
Inspection Detection	An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21CFR211 reference. Used as a classroom training tool or for self study, this training aid challenges the student to identify and justify the 21CFR211 reference that supports the 483 citation. Order form

Development Resources
CGMP Instructor Guides	Fully prepared CGMP training programs in the very popular PowerPoint format. Fully editable or ready to teach. Proven effective CGMP training designs. Order form
QSR Instructor Guides	Fully prepared CGMP training programs in the very popular PowerPoint format. Fully editable or ready to teach. Proven effective CGMP training designs. Order form
CGMP Trainers Survival Kit	An extensive collection of prepared lecture notes, quiz questions, activities, training tips and supervisory tips. Make your CGMP training preparation easy and fast. Order form

Posters
Biotech	Code	Captions	Go Shopping
	F01	Avoid contamination! Follow gowning SOPs	Download Catalog
	F02	Report cleaning deviations
	F03	Investigate cleaning deviations
	F04	Assure current practice. Follow cleaning procedures
	F05	Follow maintenance procedures

Clean Room	Code	Captions	Go Shopping
	G01	Are you properly gowned for the work to be performed?	Download Catalog
	G02	Proper gowning required - Clean room
	G03	Don't go bare, cover all head & facial hair
	G04	There is no place for soiled gowns in your work area
	G05	Replace work gloves that become damaged or soiled

Documentation	Code	Captions	Go Shopping
	A01	Follow proper documentation practices and assure good records	Download Catalog
	A02	Enter complete information to assure record integrity
	A03	Sign or initial all entries at the time work is done
	A04	Sign or initial all entries to confirm your work
	A05	Your signature means work is correct according to SOP

Hand washing	Code	Captions	Go Shopping
	D01	Wash hands before and after consuming foods	Download Catalog
	D02	Wash hands before resuming work
	D03	Give CGMPs a boost. Wash hands after restroom use
	D04	Wash with warm water, soap and dry thoroughly
	D05	Wash with warm water, soap and use single service towels

Laboratory	Code	Captions	Go Shopping
	B01	Wear safety glasses and protect your eyes	Download Catalog
	B02	Safety rules are made to live by. Wear the right equipment
	B03	Follow laboratory procedures to assure current practice
	B04	Label all reagents to avoid mix ups and errors
	B05	Always use clean laboratory glassware

Maintenance	Code	Captions	Go Shopping
	C01	Follow maintenance procedures	Download Catalog
	C02	Document all entries in real time
	C03	Assure complete & accurate log book entries
	C04	Know the current procedure before you begin
	C05	Check for change controls

Procedures	Code	Captions	Go Shopping
	H01	Follow current procedures for consistent quality	Download Catalog
	H02	Know your procedures
	H03	Training is required on all procedures for your job
	H04	Are you qualified for this procedure?
	H05	Are you qualified to perform this function?

Quality	Code	Captions	Go Shopping
	E01	Quality depends on you	Download Catalog
	E02	Quality can not be tested into the product
	E03	Build in quality!
	E04	Your responsibility is to build quality in to the product
	E05	Take pride in our products

Instrumentation	Code	Captions	Go Shopping
	J01	Is it calibrated?	Download Catalog
	J02	Have you checked the calibration status?
	J03	Check all calibration due dates
	J04	Are the calibration due dates on schedule?
	J05	Remember, tare before use


Public Seminars	GMP/QSR Trainer Certification Program - San Francisco CA October 2012	Brochure	Enroll	Hotel

California Designated Representative Certification Course
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California Exemptee Certification Course
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Florida Designated Representative Exam Preparation Course
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Alphabetical Listing of Topics

Site Map

SkillsPlus has been a leader in on site compliance training for almost 20 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 consulting.

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 needs.

21 CFR 211 - A e-learning CBT training program available for purchase or one time viewing.

CBT Training Programs - Computer based training modules available for purchase or one time viewing.

Contamination Control - A e-learning CBT training program available for purchase or one time viewing.

Documentation - A e-learning CBT training program available for purchase or one time viewing.

Free Tips - A free tips page for customers and visitors. Free upgrade areas are restricted to customers only.

GMP Posters - Beautifully hand-painted originals reproduced as posters to reinforce CGMP/QSR and Safety messages.

GMP Train the Trainer - A public and on site class training others to training in CGMP.

Organization and Personnel - A e-learning CBT training program available for purchase or one time viewing.

Posters - Beautifully hand-painted originals reproduced as posters to reinforce CGMP/QSR and Safety messages.

Public Seminars - A list of planned public seminars for the current year and next.

QSR Posters - Beautifully hand-painted originals reproduced as posters to reinforce CGMP/QSR and Safety messages.

Root Cause Analysis - A e-learning CBT training program available for purchase or one time viewing.

Subscribe to Free Previews - Call to be enrolled in the latest preview. Preview request number: 415.487.3500.

Survival Kit II - A training resources for trainers who need to conduct frequent short training sessions.

Technical Support - A knowledge base answering many questions about CBT OR e-learning programs, and on line learning management system.