Monday, April 21, 2014

Overcoming The Documentation Nightmare - A GMP Training Course - Free Video Preview

If your plant site experiences high documentation deviation rates and there's a need to drive that rate down, take a look at this course. Clear explanations of current documentation rules are provided. Numerous opportunities for students to challenge their knowledge and retention of information, keeps students engaged.

This course was designed for affordability, and quick teaching time which fits into most site's training schedules.


Watch the free video preview (6 mins long):
Click the image above, or click the following link: Overcoming The Documentation Nightmare - A GMP Training Course - Free Video Preview

Learn more about this course:
Overcoming The Documentation Nightmare - A GMP Training Course

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Friday, April 18, 2014

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus:

"In Brief, What's This Issue About?

In the US, the Food and Drug Administration (FDA) regulates many products to ensure that they are safe and effective, including medical devices such as wheelchairs and pacemakers. However, the definition of "medical device" also includes software, and in recent years FDA has moved to regulate software found on mobile phones, what most people refer to as "mobile apps."

Critics have raised the point that strict regulation of medical mobile apps could stifle innovation in the sector, while others have pointed to spurious or faulty apps to make the point that regulation is sorely needed."

'via Blog this'

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Wednesday, April 16, 2014

Hamburg to PhRMA: If you don't have quality, the rest doesn't matter - FiercePharma

Hamburg to PhRMA: If you don't have quality, the rest doesn't matter - FiercePharma:

"she said, high-risk products like sterile injectables need to be produced with proper attention for sterile procedures. Advances in science and technology can make a difference, too: Pharma can use quality by design, continuous manufacturing and other approaches to help improve both quality and efficiency in the production process, rooting out preventable problems that create shortages and compromise patient trust.

"It's just so fundamentally important," she said. "If you don't have quality, all the rest of it really doesn't matter.""

'via Blog this'

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Sunday, April 13, 2014

21 CFR 820 Essential Elements - A GMP Training Course - Free Video Preview

If you need to provide new employees with an overview of 21 CFR 820, or if you need to provide your team with a refresher, take a closer look at this course.

Numerous opportunities for students to challenge their knowledge and retention of information, keeps students engaged. This course was designed for affordability and a quick teaching time, which fits into most site's training schedules.


Watch the free video preview (5 mins long):  Click the image above, or the following link, 21 CFR 820 Essential Elements - A GMP Training Course - Free Video Preview

Learn more about this course:  21 CFR 820 Essential Elements - A GMP Training Course

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Wednesday, April 9, 2014

GMP Trainers - Ensure That They Are Qualified Individuals

GMP trainers must be "qualified individuals," according to 21 CFR 211 Subpart B.

Do you want to make sure your GMP trainers are qualified?

If you said yes, then consider this highly recommended course:
CGMP/QSR Trainer Certification Program - May 5-9, 2014 - Public Seminar in Fort Lauderdale, FL

Reference:  21 CFR 211 Subpart B:
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart B--Organization and Personnel
Sec. 211.25 Personnel qualifications.
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

You might also be interested in:
GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL
Surviving An FDA Inspection - a GMP Training Course

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Wednesday, March 19, 2014

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing

FDA Reduces GMP Inspections by 40 Percent, Focuses on Imports - PharmaManufacturing:

"The FDA plans to conduct 591 domestic good manufacturing practice (GMP) inspections in fiscal 2014 and 2015, down from the 967 performed last year. The agency in turn hopes to perform 30 percent more foreign GMP inspections, conducting 843 inspections each year, up from last year’s 604. Companies will be chosen for inspection based on the agency’s risk-based inspection model that grants leeway to high-quality companies. The FDA takes into account risk factors including Class I recalls and adverse events, as well as compliance history, in applying the risk-based inspections model to its decision making."

'via Blog this'

You might also be interested in:
GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL
Surviving An FDA Inspection - a GMP Training Course

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Friday, March 14, 2014

GMP Trainers - Why You Should Get Training

  • It's important to learn the most effective ways to train your employees
  • Never stop learning! Train & be trained as often as possible
  • Your training toolbox should have a ton of things in it. 
"The mediocre teacher tells. The good teacher explains. The superior teacher demonstrates. The great teacher inspires." - William Arthur Ward
Learn more about the GMP Trainer Certification Workshop (by SkillsPlus Intl Inc.), May 5-9, 2014 in sunny South Florida. In this course, you will be actively involved!

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Saturday, March 8, 2014

Become A Better GMP Trainer

Trainers must be skilled!
  • They must be expert course designers and facilitators
  • They must pay attention to the experiential learning process
  • They must keep students involved, engaged, and energized
It’s a given that GMP & QSR trainers must have mastery over the regulations that they are teaching. Mastering applicable laws, regulations, directives, standards, guidance, and compendia for manufacturing biologics, drugs, dietary supplements, and medical devices is essential for raising your company’s employees and management team compliance competency.

GMP & QSR trainers must also be able to help others expand their knowledge of relevant regulatory requirements, and to help others apply that knowledge in the workplace.

What does that mean?
It means that trainers must have the skills needed to teach others. We often find that trainers, program designers, training supervisors, training managers, and others who conduct GMP or QSR training in the pharmaceutical, biotech, medical device or dietary supplement industries need help in developing their training skills.
Expert GMP & QSR trainers:
  1. Focus on experiential learning processes
  2. Teach in a facilitation and learning style that’s appropriate to particular regulatory topics
  3. Design and facilitate learning activities
  4. Facilitate meaningful discussions, and create safe environments through the debrief process
  5. Model different teaching strategies
  6. Tell compelling case stories
  7. Keep students involved, engaged, and energized
If you think you or a member of your team needs help in developing training skills, then consider attending our only 2014 offering of this course, on May 5-9:
GMP-QSR Trainer Certification Public Seminar by SkillsPlus International Inc.

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Tuesday, February 25, 2014

Monday, February 24, 2014

Analytical Procedures and Methods Validation for Drugs and Biologics - New FDA Draft Guidance

FDA Guidance for Industry Analytical Procedures and Methods Validation for Drugs and Biologics - DRAFT GUIDANCE (February 2014 - PDF):

"This revised draft guidance supersedes the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and, when finalized, will also replace the 1987 FDA guidance for industry on Submitting Samples and Analytical Data for Methods Validation. It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It will help you assemble information and present data to support your analytical methodologies."

Source:


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Friday, February 14, 2014

Certified Designated Representative

 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”)." [Source: Florida Certified Designated Representative: - 'via Blog this']

Go to:  The Designated Representative and Exemptee Blog

FL Certified Designated Representative online e-Learning exam preparation by SkillsPlus Intl Inc.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc - Available around-the-clock 24 x 7 - Available for iPad
The Designated Representative Institute

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc - Enhanced for iPad
The Exemptee Institute

SkillsPlus Intl Info Blog

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Wednesday, February 12, 2014

Thursday, February 6, 2014

Tired Of Boring Training? Then Feel The Thrill of the GMP Olympics!

#FDA #GMP #QSR #cGMP #training #course #class

  • Do your employees avoid CGMP training, claiming they've heard it all? 
  • Do they resist attending CGMP training because "their" job is never discussed? 
  • Do some employees "drift off" in CGMP training because it is too theoretical? 

If you answered "Yes" to any of these questions, then you need to take a look at our GMP Olympics Refresher course.

Featured Course: GMP Olympics 
Participate in the Olympics! This course challenges even the most seasoned employee's knowledge of CGMPs. This course is definitely not for employees who are new to the industry.

Activities from this highly interactive workshop include:

  • Heard on the Street 
  • Team-based regulation review 
  • GMP Challenge 
  • Inspection Detection, and more! 
This course can be customized to meet a variety of content and time constraints.

Learn more: GMP Olympics – Course Outline

Allan Dewes
Allan Dewes, President.
About Your Instructor
Allan Dewes
  
Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention.

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Wednesday, February 5, 2014

Do You Have SOP Compliance Problems? Need Help?

#FDA #GMP #cGMP #QSR #training #course
  • Do CGMP documents contain many errors, or
  • Are change controls often side-stepped, or 
  • Is the Quality Unit often side-stepped, or 
  • Are procedures not always followed?
If you answered "Yes" to any of these questions, then take a look at our Qualstar: A CGMP Training Simulation course.

Featured Course:   Qualstar - A CGMP Simulation
Designed to teach and to change the culture of companies in order to focus on quality and compliance. This competitive simulation is an eye-opener for participant and executive staff observers alike. Issues addressed in this exciting simulation:
  1. Documentation problems
  2. Procedures not being followed
  3. Change control not practiced
  4. QA not consulted on deviations 
If this describes some of your issues, then you need to experience Qualstar!
Examine The Qualstar Outline

Ready? Set? Go! and feel the high energy of this popular and exciting course.

Allan Dewes
Allan Dewes, President.

About Your Instructor
Allan Dewes

Allan Dewes has been training employees for over 40 years, with 30 years in the pharmaceutical industry. Allan understands CGMP regulations, the FDA expectations, and how to make training fun to maximize retention.

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Thursday, January 16, 2014

GMP Training Needs To Be Conducted By Trained & Qualified Individuals

English: Training Fran├žais : Formation
English: Training Fran├žais : Formation (Photo credit: Wikipedia)
Act now to avoid these common deficiencies:
  • Failure to ensure that each person has the education, training and experience to perform their assigned functions
  • Failure to document that all personnel are trained to adequately perform their assigned responsibilities
Food For Thought On GMP Trainers:
  • cGMP trainers should be trained and qualified instructors who have the required background and experience in the subject matter. 
  • Be aware that when “repeated” errors are noted in documents, inspectors will look at training records to see if the trainers have been trained. 
  • One documentation approach is to keep resumes of all trainers on file permanently, so that they are available for FDA inspection. 
What Now?:
Useful References:

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Wednesday, January 15, 2014

Training For GMP Trainers - Commit To Excellence

Public Seminar Location: Pelican Grand Beach Resort
New Year's Day has come and gone. If your new year resolution included a commitment to professional development, then act now to sign-up for this popular public seminar workshop.

GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL

Early Bird Special - Save $600 - Limited Time Offer
Learn more:   GMP Trainer Certification Workshop - May 5-9, 2014 Public Seminar - Fort Lauderdale, FL

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Monday, January 6, 2014

About Training for GMP Trainers - Enhance Your Skills

Trainers must be skilled!
  • They must be expert course designers and facilitators
  • They must pay attention to the experiential learning process
  • They must keep students involved, engaged, and energized
It’s a given that GMP & QSR trainers must have mastery over the regulations that they are teaching. Mastering applicable laws, regulations, directives, standards, guidance, and compendia for manufacturing biologics, drugs, dietary supplements, and medical devices is essential for raising your company’s employees and management team compliance competency.

GMP & QSR trainers must also be able to help others expand their knowledge of relevant regulatory requirements, and to help others apply that knowledge in the workplace.

What does that mean?
It means that trainers must have the skills needed to teach others. We often find that trainers, program designers, training supervisors, training managers, and others who conduct GMP or QSR training in the pharmaceutical, biotech, medical device or dietary supplement industries need help in developing their training skills.

Expert GMP & QSR trainers:
  1. Focus on experiential learning processes
  2. Teach in a facilitation and learning style that’s appropriate to particular regulatory topics
  3. Design and facilitate learning activities
  4. Facilitate meaningful discussions, and create safe environments through the debrief process
  5. Model different teaching strategies
  6. Tell compelling case stories
  7. Keep students involved, engaged, and energized

If you think you or a member of your team needs help in developing training skills, then consider attending our May 5-9, 2014 GMP Trainer Certification Public Seminar in Fort Lauderdale, FL.
GMP-QSR Trainer Certification Public Seminar by SkillsPlus International Inc.
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Tuesday, December 31, 2013

Make A New Year Resolution - Take A GMP Trainer Certification Course

SkillsPlus Intl Inc.'s next public seminar of the highly popular GMP Trainer Certification Course is May 5-9, 2014 in Fort Lauderdale, FL.  Learn more: http://www.skillsplusinc.com/Pub_Sem.htm

This is a life-changing five-day class in which participants experience many different ways to teach CGMPs and QSRs. 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.
  1. Upon course completion, participants will be able to:
  2. Explain the essentials of the CGMP/QSR regulations. 
  3. Use the philosophical basis for the rules and interpretation to respond to CGMP/QSR related questions. 
  4. Demonstrate techniques to present CGMP/QSR content in memorable ways.
  5. Design and conduct activities that reinforcement learning. 
  6. Facilitate discussions and questions like a pro. 
  7. Respond to difficult questions.
  8. Deal successfully with difficult students. 
  9. Manage class room media. 
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Wednesday, December 25, 2013

Merry Christmas!


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Monday, December 23, 2013

Designated Representative Training & Exemptee Training Course - Enhanced for iPad

English: Apple iPad Event
English: Apple iPad Event (Photo credit: Wikipedia)
NEW - Now viewable on an iPad!

Our highly popular California Designated Representative and Exemptee training certification course has been refreshed, and updated to support viewing & course completion on an iPad.
  • Enhanced for iPad
  • iPad ready
  • Optimized for iPad
  • iPad viewable

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Wednesday, December 4, 2013

2014 cGMP Procedure (SOP) Writing Course

 
483 Observation Gotchas!
 
1. Firm's procedures lack sufficient detail.
2. Employees perform significant steps not included in procedures.
3. Firm lacks procedures for a variety of production, maintenance, and quality assurance activities.
 
 
 

Planning for Training 2014!


 2014 is just around the corner! 

    • Does your company constantly update and revise procedures, or
    • Are procedures the root cause of many deviations, or
    • Are procedures ignored, being replaced by word-of-mouth guidance from colleagues?
     If you answered "Yes" to one or more of these questions, then you need to take a look at our Writing Standard Operating Procedures workshop.

     

    Featured Course

    Writing Procedures: This course is as much about consulting as training. In this course, Allan reviews and consults on a firm's procedure for writing procedures, and then coaches employees on procedure writing. Employees work with existing or needed procedures in this workshop.

    Tools addressed in this very popular workshop:
    1. Readability analysis
    2. Task analysis
    3. Decision-making through procedures
    4. Determining the appropriate level of detail
    5. Task grouping for greater comprehension
    6. Procedure reviews and more!
     
    If your firm is not satisfied with the quality of procedures, then you need to look into our Writing Procedures workshop!
     

    Allan Dewes
    Allan Dewes, President.
     
    About Your Instructor
    Allan Dewes
    Allan Dewes has worked on writing procedures and training others to write procedures for over 30 years. Allan understands CGMP regulations, the FDA expectations, and how to make procedures easy to write and understand.
     

    Call Today!

    SkillsPlus International Inc.
    (415) 487-3500  |  (954) 873-7422
    San Francisco  |  Fort Lauderdale

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    Tuesday, December 3, 2013

    FDA Prepares Compounding Blacklist of Banned Products - RAPS RF

    FDA Prepares Compounding Blacklist of Banned Products - RAPS RF:

    "In a Federal Register announcement on 2 December 2013 — just days after the DQSA was signed into law — FDA said it wanted public input on which drugs should comprise such a list.

    "To identify candidates for the difficult-to-compound list, FDA is seeking public input in the form of specific drug products or categories of drug products that are difficult to compound," the agency wrote."

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    FDA aims to oversee drug compounders - USA Today

    FDA aims to oversee drug compounders - USA Today:

    ""We will be encouraging health care providers and health networks to consider strongly purchasing compounded products from FDA-registered and regulated facilities," FDA Commissioner Margaret Hamburg says. "This will be a critical step they can take to better assure the health and safety of their patients."

    Outsourcing facilities will also be required to report specific information about the products they compound, including a list of all the products compounded during the previous six months, and details about the source of the active ingredient, as well a report known as adverse effects."

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