Tuesday, January 31, 2012

Auditing: Internal and External Customers and Suppliers - Onsite GMP & QSR Class

Auditing: Internal and External Customers and Suppliers - is a live on-site cGMP and QSR class by SkillsPlus International Inc.  This training is delivered as an in-house class taught at the client's location.

Purpose:
This class teaches students how to:
  • apply an auditing model that applies to a wide-variety of situations
  • qualify suppliers, to assure that they meet your specifications and appropriate GMPs
Objectives:
Upon class completion, students will be able to:
  1. State the regulatory requirements for audits. 
  2. Identify common reactions to the audit process. 
  3. Manage adverse reactions to audits. 
  4. Plan an efficient and thorough audit. 
  5. Apply the Quality System inspection approach for audit planning. 
  6. Review relevant regulations applicable to the audit area. 
  7. Gather evidence of compliance/noncompliance. 
  8. Report results to affect change and build relationships. 
  9. Manage the corrective action and preventive action process
Topics covered in class include:
  • Managing audits
  • Pre-audit questionnaire
  • Audit focus
  • Gathering evidence
  • Ratings
  • Auditing report
Learn more about this onsite class:
Auditing: Internal and External Customers and Suppliers: SkillsPlus International Inc.

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
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Additional Keywords: affordable, biotech, cGMP, class, compliance, course, device, drug, energizing, engaging, exciting, FDA, GMP, interactive, International, manufacturer, medical,pharmaceutical, QSR, SkillsPlus, training
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Monday, January 30, 2012

cGMP/QSR Trainer Certification - Public Seminar - Oct 22-26, 2012

Updated May 6, 2014:


Did you miss our public seminar? We also offer this program as an on-site course conducted at your location. Give us a call: (415) 487-3500, or learn more:  http://www.skillsplusinc.com/Pub_Sem.htm

---
cGMP/QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then learn what your instructor is thinking about during sessions so that you can repeat that training approach in your organization. Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also.

For more details, check-out the brochure: CGMP/QSR Trainer Certification Program (PDF)

To register for the class: Register for the CGMP/QSR Trainer Certification Program

Public Seminar Schedule and Course Description:  SkillPlus International Inc.

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Wednesday, January 25, 2012

Root Cause Analysis for Better Deviation Investigations - Live onsite GMP & QSR training

Don't miss this popular course. This cGMP & QSR training class can be taught at the location of your choice, as a client on-site in-house training.

Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.:
"Purpose:
To conduct or facilitate an individual or team-based investigation that solves problems and gets results, and complies with FDA expectations in the pharmaceutical and biotech industries. 
Objectives
1. Use tools and techniques to effectively identify the deviation statement.
2. Identify the root cause of the deviation.
3. Generate and objectively select the best corrective and preventive actions.
4. Assess the risk of implementing the corrective action and preventive action.
5. Develop a contingency plan to preventive action implementation.
6. Create corrective actions and preventive action metrics. 
About the Class
1. This class uses current deviations to practice the techniques taught.
2. The optional final exam is approximately 25 questions.
3. Each student receives a student guide containing a representation of the program's
slides and graphics with space provided for note taking.
4. This class can accommodate up to 25 people.
5. Duration: 8 hours."
'via Blog this'

For more information:
Root Cause Analysis for Better Deviation Investigations: On-site Training by SkillsPlus International Inc.

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Additional Keywords: affordable, cGMP, class, compliance, device, drug,energizing, engaging, exciting, FDA, GMP, interactive, manufacturer, medical, pharmaceutical, QSR, SkillsPlus, training

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Tuesday, January 24, 2012

Live Onsite QSR Training - Olympics for Medical Device Manufacturers

Olympics for Medical Device Manufacturers - onsite QSR training by SkillsPlus International Inc. is an exciting, energizing, and engaging on-site class that can be held at a client in-house location.

This challenging class takes QSRs to a deeper level of understanding through a series of challenging activities.

Upon class completion, students will be able to:
  1. List the hottest issues in QSR compliance. 
  2. Locate items of interest in 21CFR820. 
  3. Explain the 21CFR211 rationale for specific 483 observations. 
  4. Demonstrate knowledge of common CGMP practices and details. 
  5. State the consequences of not following QSR.
For more information:

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Additional Keywords: affordable, class, compliance, course, device, energizing, engaging, exciting, FDA, interactive, manufacturer, medical, QSR, SkillsPlus,
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Monday, January 23, 2012

Live Onsite GMP Training - Olympics for Pharma & Biotech Manufacturers

Exciting, energizing, engaging, live client site class held at your location.
Olympics for Pharmaceutical and Biotech Manufacturers - On-site cGMP Training by SkillsPlus International Inc.

This class takes CGMPs to a deeper level of understanding through a series of challenging activities.

Upon class completion, students will be able to:
  1. List the hottest issues in CGMP compliance.
  2. Locate items of interest in 21CFR211. 
  3. Explain the 21CFR211 rationale for specific 483 observations. 
  4. Demonstrate knowledge of common CGMP practices and details. 
  5. State the consequences of not following CGMPs.
For more information:
Additional Keywords: affordable, biotech, cGMP, class, compliance, computer, computer-based training, cosmetics, course,drug,energizing, engaging,exciting, FDA, GMP, instructor, interactive, manufacturer,pharmaceutical,SkillsPlus, training
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Wednesday, January 18, 2012

Live Onsite QSR Training - Essentials for Medical Device Manufacturers

Here's one of our popular onsite QSR training classes:
Essentials for Medical Device Manufacturers by SkillsPlus International Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of QSR for beginning work in the medical device industry.

Upon completion of this class, students will be able to:
  1. State the historical development of QSR regulations. 
  2. Explain the role and function of standard operating procedures. 
  3. Describe the personal role for contamination control. 
  4. Identify the sources of contamination. 
  5. List the common QSR documentation practices. 
  6. Explain material controls. 
  7. State the common practices of production and process controls. 
  8. Explain the importance of an adequate, appropriate, and sufficient building design. 
  9. State the requirements of equipment design and construction. 
  10. List the requirements for building, and equipment cleaning and maintenance. 
  11. Explain the role of the quality management system. 
  12. Explain the role of the laboratory.
Learn more about this class:
Essentials for Medical Device Manufacturers - On-site training by SkillsPlus International Inc.

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Monday, January 16, 2012

Live Onsite GMP Training - Essentials for Pharmaceutical Manufacturers

Here's one of our popular onsite cGMP training classes:
   Essentials for Pharmaceutical Manufacturers - cGMP training by SkillsPlus Intl Inc.

This live class can be taught at the client site location of your choice.

This class teaches employees how to identify the essential elements of CGMP for beginning work in the pharmaceutical and biotech industries.

Upon completion of this class, students will be able to:
  1. State the historical development of CGMP regulations. 
  2. Explain the role and function of standard operating procedures. 
  3. Describe the personal role for contamination control. 
  4. Identify the sources of contamination. 
  5. List the common CGMP documentation practices. 
  6. Explain material controls. 
  7. State the common practices of production and process controls. 
  8. Explain the importance of an adequate, appropriate, and sufficient building design. 
  9. State the requirements of equipment design and construction. 
  10. List the requirements for building, and equipment cleaning and maintenance. 
  11. Explain the role of quality assurance. 
  12. Explain the role of quality control.
Learn more about this class:
Essentials for Pharmaceutical Manufacturers - cGMP training by SkillsPlus Intl Inc.

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SkillsPlus Intl Inc. - GMP & QSR Compliance Training Experts website
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Additional Keywords: affordable, biotech, cGMP, class, compliance, computer, computer-based training, cosmetics, course,drug,energizing, engaging,exciting, FDA, GMP, instructor, interactive, manufacturer,pharmaceutical,SkillsPlus, training
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Monday, January 9, 2012

cGMP QSR On Site Classes - The Benefits

On-site training is the perfect choice for companies that need to train groups of employees.

Onsite Training Benefits:
  1. You get a maximum number of employees trained in new skills in a minimal amount of time on the date, and location of your choice. 
  2. You'll be able to deliver the same customized message & course content at the same time, ensuring everybody gets on the same page. 
  3. You can ensure knowledge & skills transfer from classroom to workplace. 
  4. You can minimize employee time away from the office or production line. 
Taking advantage of onsite training classes gives you the optimal balance of facilitation, group exercises, case studies, and practical application exercises. Call our master trainer, Allan Dewes, to arrange your next client site class, (415) 487-3500.

You might also be interested in:
2012 cGMP & QSR compliance training course catalog by SkillsPlus International Inc.

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Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT
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Wednesday, January 4, 2012

2012 Onsite cGMP & QSR Compliance Courses by SkillsPlus Intl Inc.

Happy New Year!

Now that 2012 is here, don't delay your training planning.

We've got an exciting, energizing, and engaging slate of cGMP and QSR training courses and classes to offer you.

Check out our new:
2012 cGMP & QSR compliance training course catalog by SkillsPlus International Inc.

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Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT
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Tuesday, January 3, 2012

About Florida Certified Designated Representative (CDR)

Florida Department of Business and Professional Regulation - Certified Designated Representative:
"Drugs, Devices, and Cosmetics Program - Certified Designated Representative: All prescription drug wholesale distributor and out-of-state prescription drug wholesale distributor permittees and applicants must designate in writing at least one natural person to serve as the designated representative for a given establishment. Such person must have an active certification from the department (a “certified designated representative” or “CDR”)."
'via Blog this'

Learn about the FL CDR program at the webpage above. It covers:

  • requirements
  • application
  • certification criteria
  • operational requirements
  • fees

You might also be interested in:
Florida Designated Representative Study Course: online web training by SkillsPlus International Inc.

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SkillsPlus Intl Inc. - GMP Compliance Training Experts website
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Additional Keywords: affordable, based, biotech, CA, CBT, CDPH, CDR, certification, certified, Certified Designated Representative, cGMP, class, compliance, computer, computer-based training, cosmetics, course, DBPR, DDC, designated, designated representative, device, DME, drug, eCourse, e-Course, elearning, e-learning, energizing, engaging, etraining, e-training, exam, examination, exemptee, exciting, FDA, FL, Florida, glossary, GMP, HMDR, HME, IBT, instructor, interactive, International, internet, manufacturer, medical, movie, online, Pearson VUE,pharmaceutical, prep, preparation, provider, public, QSR, representative, resources, seminar, SkillsPlus, social, trainer, training, video, WBT
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