CGMP Online Courses
By SkillsPlus International Inc.
Current Good Manufacturing Practice Training: A New Generation Series
If you are visiting here, ask yourself these three questions:
- Do you need to conduct CGMP Training on a limited budget?
- Do you want employees to learn the CGMPs from an expert using real
- Do you need CGMP Training resources suitable for multiple levels of the
If you answered YES to any of these three questions then you should take a
look at the courses below:
We Offer Two Approaches
Select the approach best suited for your site. Pricing varies.
- Hosted Training - SkillsPlus will host your employees within our
Learning Management System.
- Ownership - Your firm purchases the content in either a
non-editable or editable format, for ultimate upload into your LMS or
Course Management System (LMS/CMS).
Call or email us for a free preview or quote! (415) 948-5220 | Allan.Dewes@SkillsPlusInc.com
Benefits of Our Hosted Approach
- No need for you to spend time researching new and interesting, talking
- Flexible delivery schedule means less adverse impact to plant
- Keeps the plant running by spreading out the training over time.
- Narration captioning aids those who need hearing assistance or for
English as a Second Language (ESL) employees.
- No more consultant travel expenses, day-long line shutdowns, or
expensive group lunches.
- Hosting your content may be possible, but would require a multi-year
- Very affordable!
General Features of Either Approach
- Allan's 40 years of industry experience and knowledge is built into each
- The rules are amplified through many examples.
- Fully animated with colorful and interesting graphics and images.
- Fully narrated for an engaging presentation.
- Captioning to assist ESL and hearing-impaired employees.
- One-time use, or annual access contracts available.
- No Adobe Flash Player code or video to bog down network systems.
- Excellent customer service! We return phone calls.
- Used as on-line self-study courses for all employees, new employees,
contractors, vendors and temporary employees.
- Used as classroom presentations to add variety to your live training. This
option offers a single user access, without access to the quiz or completion
certificate. Fees are based on a combination of the number of total
employees, expected number of access sessions, and corporate annual sales
- Supplements your own instruction with examples that you can share with the
- Used as a content resource as you develop your own in-house
- Use specific topics as part of CAPA recommendations.
Hosted Approach: Features, benefits, and collateral materials
Features of Our Hosted Approach
All these features are included so long as at least 2 topics are selected and
you are enrolling at least 25 employees. If only a single topic is selected or
you are enrolling less than 25 employee some features below can be made
available for an additional charge.
- SkillsPlus uploads your employees, each with a unique username and
password. We can work with your in-house username conventions.
- SkillsPlus emails to each employee their unique sign in instructions, to
get started. Here you can add any additional information that employees need
to know, just as if you did all this yourself. If your employees do not have
a personal email address, we will email the sign in instructions to your
- Your firm has a unique gradebook for each class to which we can grant
access to one person to monitor employee training progress.
- You decide if the employee needs to view all presentations within a topic
before taking a quiz.
- Your firm sets the quiz passing grade requirement, the number of attempts
to obtain a passing quiz grade, and if a passing grade is a requirement to
print a certificate.
- You decide who gets copies of training completion certificates, in
addition to the student. The Certificate URL for each topic may need to be
whitelisted within your firm's server for this to function completely.
- A monthly report will be sent to your designated individual(s) reporting
each employee's grade.
- You can customize the course landing page. Here you can remind employees
of due dates, passing grade requirements, and other important details.
- You decide if employees will complete a course evaluation following
- Create different training curricula for different employee groups.
- Content is hosted on the SkillsPlus on-line classroom (LMS) and requires a
laptop or desktop computer with internet access, and speakers or headset to
complete the training.
- Content customizing service available through SkillsPlus, schedule a call
to discuss your customizing needs!
- Handouts to support each topic in PDF format can be printed for student
reference. Handouts are distributed to each student by either: download by
the employee from within the LMS classroom and printed; emailed to each
employee along with their sign in instructions; or emailed to the training
department for pre-printing and made available to each employee.
- Quizzes are taken online.
- A copy of the CGMP Regulation is available within the classroom and can be
printed by the student or your training department staff or designate.
Ownership Approach: Features, benefits, collateral
materials, and add-on fees
Features of the Ownership Approach
- Purchase an ownership license to install course content into your own LMS
- Globally! Please note that we do not provide technical support for
installing our content into your LMS or CMS, as there are too many LMS/CMS
technologies for us to troubleshoot.
- Purchase is delivered via download in a ZIP file format.
- Content is published using SCORM 2004 Edition 4.
- Presentations are presented using HTML5 with Flash as a backup.
- We can provide to you a test install file to verify that your purchase
will install into your LMS or course management system successfully, before
you purchase. Let us know if your LMS has a file size limit on uploaded
- Self-editing of our Storyline content requires an Articulate Storyline
license. If this purchase option is selected you will download native
Articulate Storyline files. Audio can be edited to remove content within
Storyline. New audio must be recorded in your voice from within Storyline.
See Customizing Services below.
- Content customizing services are available through SkillsPlus. Schedule a
call to discuss your customizing needs!
Benefits of the Ownership Approach
- One time purchase with no per student, annual or global licensing fees.
- Non-editable versions are selected to use as SkillsPlus envisioned the
training. This is a published Storyline file zipped and ready to install
into an LMS. Content does not run outside of a LMS or course management
- Editable Versions and Options:
- Self-Editable Version - This allows the training department to
customize images, text and animation timing. Please see Customizing
Services below, for assistance with audio re-recording.
- Non-Editable Version - If you purchased a non-editable version
and decide after the purchase that you need customizing, please see
Customizing Services below.
- Customizing Services - Customizing services is provided by
SkillsPlus and allows for the inclusion of: company-specific rules and
procedures, confidential information, custom graphics and images, custom
animations, quiz question editing or creation, narration writing, changes,
and recording, and captioning. Please see Customizing Services below.
- Customizing of client edited programs. If you purchased an editable
version of the content, and need our assistance with content, graphics,
images, animation, narration, or captioning, please see Customizing
- If you use our handout there is no need to edit anything. Let us know if
you want us to customize our handout for you. A small fee is charged for
- Storyline allows for limited Microsoft Word file publishing. We can share
with you how we have designed our handouts.
- A Microsoft Word copy of the SkillsPlus topic quiz is provided as a
starting point, for any topic you purchase.
Customizing Services for A Fee
The following services are available, please request a quote.
- Total Customizing - Customizing services by SkillsPlus is available
and allows for the inclusion of; company-specific rules and procedures,
confidential information, custom graphics and images, custom animations,
quiz question editing or creation, narration writing, changes, and
recording, and captioning. Graphics and images may be supplied by you, or
SkillsPlus can make recommendations. This is billed on an hourly rate. We
can provide an estimate. When finished, the client will receive a
self-editable Storyline version, as well as a published version.
- Narration Recording and Captioning - If you need to modify the
narration, but do not want to record it yourself, you can use our
"Voices" to re-record affected audio files. Fees apply and are
based on the length of the narration.
- Non-Editable Version - If you purchased a non-editable version and
decide after the purchase that you need customizing, we will treat that as a
Total Customizing purchase and we would be happy to provide a quote for that
- Customizing of Client-Edited Programs - If you purchased an
editable version of the content, and need our assistance with the inclusion
of: company-specific rules and procedures, confidential information, custom
graphics and images, custom animations, quiz question editing or creation,
narration writing, changes, and recording, and captioning. Graphics and
images may be supplied by you, or SkillsPlus can make recommendations. This
is billed on an hourly rate. We can provide an estimated. When finished, the
client will receive a self-editable Storyline version, as well as a
- Fixing client slide animation, or fixing client attempts to modify
SkillsPlus animation, is billed per hour. If the animation issue does not
appear broken in the SkillsPlus LMS, then by definition any animation timing
or appearance issue is a function of the client LMS. We can attempt to alter
the animation for you. This service will be billed on an hourly basis.
How Do I Know the Content Is "Right" for Us?
- Prior to your purchase you will have an opportunity to view the entire
program within our LMS. This provides for two (2) reviews of the content. We
recommend one view for yourself, and then schedule a review with your
internal decision-making teams. Once you have decided to purchase a topic,
additional review sessions for identifying any content modifications are
available, following receipt of a purchase order.
- The content is based on commonly used CGMPs based on our experiences, and
does not take into consideration the suitability of the examples or
approaches discussed to your plant environment or product. This is training
and not consulting. The purchaser is responsible for assuring that the
content contained there within is suitable and appropriate for their plant,
prior to purchase.
Learn the highlights of 21 CFR 211. Get employees off on
the right foot in your plant with this training, which is an excellent
orientation to CGMPs for new employee, or a great quick and handy refresher for
longer tenured employees.
- Subpart A (3 Minutes 32 Seconds)
- Subpart B (5 Minutes 20 Seconds)
- Subpart C (5 Minutes 7 Seconds)
- Subpart D (3 Minutes 53 Seconds)
- Subpart E (7 Minutes 4 Seconds)
- Subpart F (6 Minutes 54 Seconds)
- Subpart G (7 Minutes 14 Seconds)
- Subpart H (2 Minutes 23 Seconds)
- Subpart I (6 Minutes 54 Seconds)
- Subpart J (7 Minutes 3 Seconds)
- Subpart K (2 Minutes 37 Seconds)
Number of Quiz Questions: 11
Back to top
- Introduction (1 Minutes 58 Seconds)
- This presentation introduces the topic, Your Personal
Responsibility, a review of the CGMP requirements in 21 CFR 211 -
Subpart B: Organization and Personnel.
- The Quality Control Unit (13 Minutes 46 Seconds)
- The Quality
Assurance Unit (QA) is a special team with special responsibilities. Help
your team understand the critical role of QA through a review of the
systems that QA manages. Understanding the concern for any conflict of
interest clarifies who can and should perform various tasks. Two landmark
court cases of interest to senior leadership are reviewed.
- Training, Education and Experience (20 Minutes 55 Seconds)
- In this
presentation a firm can benchmark its training program to the
pharmaceutical industry's "Gold Standard," including training
effectiveness. This presentation ends the discussion of, who needs to be
trained, and what qualifies an individual to become a trainer in the
pharmaceutical industry. In response to deviation CAPAs we'll clarify when it
is appropriate to use retraining.
- Adequate Staffing (2 Minutes 24 Seconds)
there are rarely sufficient staff to meet our desires, this presentation
discusses the regulatory requirement for adequate staffing, including
individual roles and responsibilities.
- Sources of Contamination (17 Minutes 30
manufacturer spends a lot of time, effort and money attempting to control
for contamination. This topic brings more employees into that effort
through a greater understanding of the sources of contamination, therefore,
the rationale for many plant rules, and restrictions on personal items.
of Hand Washing (6 Minutes 37 Seconds)
- Every night
the need for hand washing is reported on television, but the
recommendation for hand washing is not new. This presentation takes a step
back in time to review when hand washing actually became a recommended
practice and for whom. The FDA regulatory requirements for hand washing
guidelines are explained. A review of hand washing practices in the United
States helps to reinforce the need to wash hands.
- Hand Washing Method (2 Minutes 20 Seconds)
presentation reviews recommendations for proper hand washing, and common
handwashing mistakes. The CDC's guidelines on the proper use of
alcohol-based hand sanitizers are summarized.
(8 Minutes 6 Seconds)
- Working in a
pharmaceutical manufacturing facility, regardless of the department,
requires unique g
owning for different environments. However, gowning
isn't just wearing the clothing items correctly, it also includes:
managing and maintaining clean clothing before, during and after work.
Restricted access areas are explored as it relates to proper gowning. This
topic does not attempt to change your company's procedure on proper
gowning sequences, as every company has their own expectations.
- Illness and Lesions (3 Minutes 5 Seconds)
everyone has had the occasional cold or flu, and the CGMPs provide
guidelines on handling illness and open lesions of employees. Everyone
needs to know their role within this important responsibility.
Number of Quiz Questions: 30
Back to top
It is recommended that this program be divided into two sections: general
plant audience; and facility engineering and maintenance. The asterisk (*)
indicates topics intended for the general plant audience.
- Introduction* (3 Minutes 49 Seconds)
- This presentation introduces the topic, Foundation to
Facility, a review of the CGMP requirements in 21 CFR 211 - Subpart C:
Buildings and Facility.
- Space & Design* (16 Minutes 41 Seconds)
- Pharmaceutical production facilities are located in
every imaginable location, from inner cities, to sprawling
country-side; and placed in newly constructed facilities or
retrofitted facilities (as old as 100 years old). Plant management and
engineers, planning on a new facility and location, managing an
existing plant location, or retrofitting a facility, must understand
the many factors impacting facility placement. Space use and logical
flow, is explained in detail. Security concerns are also discussed.
- Suitable Construction* (8 Minutes 53 Seconds)
- Constructing a pharmaceutical manufacturing facility
is not like building a new house. This presentation answers many
questions that the facility design and construction engineer and
maintenance personnel have requiring design considerations for: walls,
floors, windows, doors, and piping.
- Defined Areas (15 Minutes 43 Seconds)
- This presentation lists and discusses the rationale
for many defined areas in a pharmaceutical manufacturing facility,
including common industry practices.
- General Utilities* (5 Minutes 3 Seconds)
- Oftentimes, one takes for granted that the lights
will go on, and stay on. This presentation describes the regulatory
requirements for: ensuring adequate lighting for the work performed,
electricity for equipment, sufficient and suitable gas for operations,
proven automation, and fire protection.
- Air Filtration* (2 Minutes 13 Seconds)
- Most people today use HEPA filters on their home
heating and air conditioning systems, and rarely is it given another
thought until the filter needs to be replaced. This
presentation goes beyond those basic requirements and explores the
regulatory considerations for: air filtration, air exhaust,
recirculating air, and air filtration requirements when there is a
risk of penicillin cross-contamination.
- Temperature & Humidity* (5 Minutes 19
- At home, the refrigerator is filled with products
that require refrigeration. Everyone has heard about the extreme cold
storage environment for the COVID-19 vaccine. But rarely do we think
about the wide range of storage environments for pharmaceutical
presentation explains all of the USP temperature storage environments.
Humidity is explained in detail including the risks of extremely high
or extremely low humidity levels in a production facility.
- Air Classification* (8 Minutes 53 Seconds)
- This presentation explains the air classification
systems used to evaluate a pharmaceutical manufacturing environment,
including a detailed explanation of air pressure differentials for
clean rooms and containment areas.
- Plumbing & Drains* (2 Minutes 50 Seconds)
- Many cities and towns today require a check valve or
an air-break on outside water spigots or bibbs. This presentation
explores the CGMP plumbing considerations which many employees must
use daily, including: drainage systems, check valves, or air-breaks.
- Plumbing Design (4 Minutes 49 Seconds)
- Lead pipes are no longer used in much of the western
world, and perhaps beyond. Plumbing and piping in the pharmaceutical
manufacturing facility have an even higher set of requirements, which
many employees need to understand, including: plumbing, piping, water
types, and water generation systems.
- Water Storage (3 Minutes 9 Seconds)
- Pharmaceutical manufacturing rarely, if ever, uses
tap water for use in the facility. This presentation clarifies the
general requirements for water storage and distribution, including:
water system construction, water storage and distribution, and piping
- Steam & Chilled Water (1 Minute 15 Seconds)
- Sometimes the plant needs very hot water, sometimes
it needs steam, and sometimes it needs chilled water. This
presentation defines the different types of steam, and where steam is
used in a pharmaceutical facility. Chilled water uses, and system
design considerations are also explored.
- Pest Control* (1 Minute 54 Seconds)
- No one wants to see pests or rodents at home, or in
your favorite restaurant. Neither should we see them in a
pharmaceutical manufacturing facility. This presentation reviews for
all employees the CGMP pest control requirements, and highlights a
pest control technician's many recommendations for pest and rodent
- Cleaning & Maintenance (6 Minutes 25 Seconds)
- Not much thought goes into taking the trash out at
home. However, in a pharmaceutical manufacturing facility, employees
must be aware of the risks of these sources of product contamination:
trash and refuse removal, dust collection, and routine work area
cleaning. Clean-In-Place, and Sterilize-In-Place or Steam-In-Place
options are explained. Maintenance regulatory expectations are
explored, including: the need for procedures, controls for
Building Automation Systems, and expectations for facility design
documentation and drawings.
- Environmental Monitoring (4 Minutes 28 Seconds)
- After an employee works in a clean room or
containment room for several weeks or months, it is easy to forget the
regulatory requirements and rationale for the environmental controls
and monitoring systems. The program raises awareness of the importance
of environmental monitoring procedures, reports, and methods.
- Wrap Up* (30 Seconds)
Number of Quiz Questions: 77
Back to top
- Introduction (1 Minute 40 Seconds)
- This presentation introduces the topic, Maintaining Compliant
Equipment Practices, a review of the CGMP requirements in 21 CFR 211 -
Subpart E: Equipment.
- Equipment Design (2 Minutes 37 Seconds)
- Before ordering that new manufacturing or packaging machinery, it is
important to fully understand the regulatory requirements for
equipment design, size, location, and blueprints, as discussed in the
- Materials of Construction (4 Minutes 46 Seconds)
- Learn the oftentimes confusing considerations around equipment
materials of construction interactions with drug product materials,
including: non-reactive, non-absorptive, and non-additive, when
considering equipment that will contact product. Lubricants and
coolants are also explained.
- Equipment Cleaning (6 Minutes 5 Seconds)
- So, you were tasked with cleaning the equipment. Before you get
started it is essential to have a strong understanding of the
regulations covering: equipment cleaning, cleaning goals, and the
levels of cleaning, depending on the production environment.
- Maintenance and Calibration (9 Minutes 41 Seconds)
- Maintenance in a pharmaceutical manufacturing facility is more than
basic maintenance. Through this presentation personnel learn the extra
requirements for equipment maintenance, with special attention given
to: automatic, mechanical, and electronic. Calibration practices are
explained including: national standards, calibration schedules,
calibration documentation, out of calibration documentation,
calibration Investigations, and calibration status indications.
Special attention is given to changes to computer systems and the
regulatory requirement for computer validation.
- Cleaning and Maintenance Documentation (3 Minutes 38 Seconds)
- Cleaning and maintenance documentation is critical when
investigating problems. This presentation explains the many different
cleaning and maintenance documents required in the pharmaceutical
industry. Special attention is given to equipment cleaning and use
logs, which are often the subject of regulatory criticism. The use of
equipment identification codes is also clarified.
- Filters (2 Minutes 55 Seconds)
- Liquid filtration is a special filtering case. This presentation
describes the regulatory requirements for liquid filtration in the
- Procedures and Change Control (9 Minutes 13 Seconds)
- When it comes to equipment, one should never make it up as you go.
This presentation explores the requirements for equipment procedures,
and the controls around changes to those documents. An in-depth review
of equipment cleaning and maintenance procedures is explored,
including change control. One change control model is described in
- Training (4 Minutes 59 Seconds)
- Not all training is the same, or effective. "Read and
Understand" training has its place, and it is limited. This
presentation explains the importance of job skills training for
employees expected to operate equipment safely to produce a quality
product. The "Gold Standard" for training and training
effectiveness is explored, including different levels of training for
different levels of the organization.
- Qualification and Validation (4 Minutes 57 Seconds)
- Do not start designing or reviewing a validation protocol until you
have considered the issues involved in qualification and validation.
This presentation examines the regulatory requirement for validation,
including six elements of an effective validation plan. The instructor
links validation to compliance with procedures and training.
Number of Quiz Questions: 34
Back to top
- Introduction (2 minutes 4 Seconds)
- This presentation introduces the topic, Supplier to Plant, a review
of the CGMP requirements in 21 CFR 211 - Subpart E: Components, Drug
Product Containers and Closures
- Receipt of Materials (12 minutes 30 Seconds)
- Continue to learn the lingo of the industry. This presentation
defines critical terms used to describe different types of materials
in pharmaceutical manufacturing. The presentation explores the
regulatory expectations for procedures, the proper handling of
materials to prevent contamination, the handling and storage of boxed
or bagged components, identification of received materials, and
container examination activities. The use of a material control system
- Random & Representative (9 minutes 03 Seconds)
- It is essential to understand what sampling is, and the rationale
for those expectations. This presentation explains representative
sampling, including: why sampling is needed, and how the firm is able
to maintain confidence in its decision-making based on sampling.
Random sampling is defined and explained. Sampling, relative to
acceptance criteria is discussed. Sampling bias is explained and
related to following procedures.
- Sample, Test & Inspect (6 minutes 45 Seconds)
- Good sampling practices is more than just following the procedure.
This presentation explains the methods of collecting samples and the
rationale for those expectations. This presentation describes good
sampling techniques, and general considerations for testing materials
for conformity, including: containers and closures. Examination for
contamination is also addressed. The requirement for component, accept
or reject decisions is also explained.
- Material Use (8 minutes 04 Seconds)
- Rotating milk through the refrigerator is one simple form of using
the oldest approved stock first. In pharmaceutical manufacturing it is
much more complicated. This presentation explores the common industry
practices for using the oldest approved stock first. Other topics
include: retesting of drug substances, the proper handling of rejected
materials, and restrictions on container closure interactions with
drug products. The function of containers and closures is also
explained, as it isn't as obvious as you might think. Consideration is
given for preparing containers and closures for use, given a variety
of different product categories. Exceptions for medical gases are
described. Component record contents is described.
- USP Storage Containers (4 minutes 04 Seconds)
- This presentation opens the world to the wide variety of USP
container closure systems.
- Examination & Usage (10 minutes 32 Seconds)
- Firms invest much time and resources into making sure all labeling
is correct, suitable and preserved. This presentation makes the
distinction between labels and labeling. It clarifies the expectations
for the examination of labeling. It explains the receipt, storage,
handling, and sampling of labeling. The instructor simplifies the
regulatory requirement for different handling practices of approved,
or rejected labeling supplies. The "per shipment"
documentation requirement for labels is explained. A detailed
explanation of controlled storage is provided. A label printing firm
shares best label storage practices. The proper handling for updated
or obsolete labels is also described. Gang printing and cut labeling
regulatory controls are explained and defined, including special
handling requirements for online printing devices is also examined.
- Components Records (3 minutes 22 Seconds)
- The documentation never ends and therefore, this presentation
discusses all the different records that need to be maintained to
support the proper handling of: materials, components, containers,
closures, labels and labeling.
- Wrap Up (1 minute 14 Seconds)
Number of Quiz Questions: 30
Back to top
- Introduction (2 minutes 34 Seconds)
- This presentation introduces the topic, Plan to Production, a review
of the CGMP requirements in 21 CFR 211 - Subpart F: Production and
- The Regulations (20 minutes 04 Seconds)
- This presentation reviews the wide range of regulatory requirements
for production and process controls.
- Sampling (9 minutes 44 Seconds)
- This instructor provides a detailed review of sampling. The
representative sample requirement is explained, including confidence
in decisions based on the tests and inspections of samples. The random
sample, and random sampling, is explained through a demonstration,
including: ways of obtaining a random sample, understanding if a
sample is representative, and sample bias.
- Control Charts (6 minutes 34 Seconds)
- This instructor explains control charts in an easy and simple way so
employees better understand the different ranges within the control
chart, and the signals in a controlled chart indicating the need for
employee immediate action.
- Validation Introduction (4 minutes 51 Seconds)
- This presentation introduces validation and many common terms used
through the next several topics.
- Validation Regulations (3 minutes 46 Seconds)
- Validation requirements were a relatively recent addition to the
CGMPs, so it is important that this presentation reviews validation
- Validation Strategies (4 minutes 02 Seconds)
- Validation is not as complicated as some would make us believe. This
presentation simplifies common validation strategies including:
prospective validation, concurrent validation, retrospective
validation, and revalidation. Attention is given to comment triggers
- Validation Qualifications & Challenges (11 minute 16 Seconds)
- Validation qualifications and challenges are much more than just a
test drive. This presentation explores, in simple terms, the
qualifications and challenges of validation. This includes: design
qualification, installation qualification, operation qualification,
performance qualification, worst-case challenges, and revalidation.
- Documentation and What It All Means To You (2 minutes 36 Seconds)
- This presentation pulls it all together by explaining the
requirements for documenting all validation work, and what validation
work means to each and every employee in a pharmaceutical
manufacturing environment, including the importance of following
procedures and reporting deviations.
- Wrap Up (50 Seconds)
Number of Quiz Questions: 30
Back to top
- Introduction (1 minute 39 Seconds)
- This presentation introduces the topic, Plant to Patient, a review
of the CGMP requirements in 21 CFR 211 - Subparts G (Packaging &
Labeling), H (Holding & Distribution), & K (Returned and
Salvaged Drug Products)
- Labeling Issuance (5 minutes 47 Seconds)
- Ever wonder why labels and labeling are carefully controlled? This
presentation clarifies all that through discussion about: the USP and
CGMP definitions for labels and labeling, the regulatory requirement
and rationale for controls around label issuance, and examination
prior to use. Learn the rationale for: label reconciliation, handling
excess labeling imprinted with a lot number and/or expiration date,
and the extra controls for returned labeling supplies. It's much more
than the money!
- Packaging and Labeling (6 minutes 32 Seconds)
- Every work environment must be maintained appropriately. Packaging
is no exception. This presentation examines the critical controls
necessary for maintaining a suitable packaging and labeling operation.
Special attention is given to the prevention of cross contamination,
and the handling of unlabeled product. The detailed examination of lot
or control numbers is explored from the regulatory perspective. The
examination of labeling supplies prior to use is also explained. The
importance of facility examination and inspection prior to use is
examined as well as an examination of product during and following
packaging. Documentation requirements are also explained.
- Expiration Dates (5 minutes 32 Seconds)
- Most people respect the expiration dates of the products they
purchase and this presentation describes the regulatory requirement
for those expiration dates. The USP definition of expiration dates is
explained. This presentation examines expiration dates and storage
conditions, and special requirements for reconstituted products.
Requirements for homeopathic products, allergenic extracts, and new
drug products for investigational use are covered.
- Tamper-evident Packaging (9 minutes 12 Seconds)
- Everyone has heard about the Tylenol tampering incident in 1982.
This presentation explains in simple terms the requirements for
tamper-evident packaging to include: evidence of tampering,
distinctive design, different types of container closure systems,
special controls for two-piece gelatin capsules, different types of
packaging options, and requirements for labeling of tamper evident
- Warehousing & Distribution (8 minutes 00 Seconds)
- Never again hear a warehouse employee say they didn't learn
something new in CGMP training. This presentation expands and explains
the very important responsibilities of the warehouse including:
distribution of product, compliance with indicated storage conditions,
understanding USP temperature ranges and humidity standards, climatic
zones, and how climatic zones impact stability studies. Temperature
excursions are explored as detailed in the USP. The use of temperature
monitoring devices is explored. As a part of distribution, recalls are
also considered. Distribution records are described.
- Returned & Salvaged Drug Products (4 minutes 50 Seconds)
- Drug product tampering, intentional adulteration, and theft are at
record levels, and a major concern for the pharmaceutical industry.
This presentation explains the regulatory restrictions of returned
drug products as explained in the CGMPs, and the Drug Supply Chain
Security Act (DSCSA). Limitations on reprocessing and salvaging are
also explained. This presentation also discusses returned product
- Complaints (2 minutes 34 Seconds)
- Your firm just received a complaint, so where does one begin? This
presentation explores the requirements for complaint procedures,
complaint records and required content, and the record retention
- Recalls (3 minutes 28 Seconds)
- Not all recalls are alike. This presentation explains the many
required recall activities, including: the classification of recalls,
required information to support the FDA's need for information about a
recall, notifications to the public, customer instructions,
notifications to the press, and recall effectiveness activities.
- Wrap Up (1 minute 3 Seconds)
Number of Quiz Questions: 32
Back to top
- Introduction (2 minutes 30 Seconds)
- This presentation introduces the topic, Laboratory to Release, a
review of the CGMP requirements in 21 CFR 211- Subpart I: Laboratory
- General Requirements (10 minutes 2 Seconds)
- If you have ever wondered what really goes on the QC laboratory,
this presentation describes the requirements and activities of a
quality control laboratory. This includes: testing references, using
test methods that are scientifically sound and appropriate, making the
determinations that materials and products conform to written
specifications, laboratory instrument calibration, the acceptance and
controls around the acceptance of a certificate of analysis, and the
handling of animals in the laboratory.
- Documentation (9 minutes 10 Seconds)
- Good laboratory documentation practices are far beyond basic. This
presentation describes the documentation practices unique and specific
to a quality control laboratory including: the use of electronic
records in the laboratory, handling laboratory notebooks and bound
journals, loose pre-numbered worksheets, and blank sheets in the
laboratory. Other topics covered in this presentation include: data
recording, understanding significant figures, reading of values for
liquids in measuring vessels, appropriate and inappropriate uses of
averaging test values, the requirements for reagent labeling, the
importance of the analytical result review including the Quality
Assurance review, required records, laboratory investigations, and
laboratory record retention.
- Specifications and Acceptance Criteria (3 minutes 35 Seconds)
- Specifications and acceptance criteria are much more than just a
value within a range. Through this presentation learn the requirements
for specifications and acceptance criteria. Explore the topics of
testing and release based on appropriate laboratory determination, the
elements of specifications, acceptance criteria, the description of
specification ranges, controls and tests for objectionable
microorganisms; and special testing for sterile and pyrogen-free
products, ophthalmic ointments, and controlled-release products.
- Sampling (4 minutes 15 Seconds)
- In this presentation employees learn about samples and sampling from
the laboratory perspective. Sampling plans are explained, as well as,
describing the use of sampling plans. Special consideration is given
to sterile products. The use and misuse of composite samples are also
explained. In addition to routine samples, other types of regulatory
samples are also defined.
- Method Validation (7 minutes 50 Seconds)
- Test method validation seems so complicated because of all the funny
labels used. This instructor simplifies test method validation so
everyone can understand it. The USP test method classification system,
the different studies for each USP classification and method transfer
are presented in plain and simple terms.
- Out of Specification (9 minutes 45 Seconds)
- Just got a test value that is out-of-specification? What to do has
been clarified. This presentation explains clearly the expectations
for out-of-specification (OOS) test results. The landmark court case
of, United States vs. Barr Laboratories is reviewed from the
perspective of OOS test result expectations. Out of specification test
result actions to be taken by laboratory analysts are reviewed
including immediate actions, and prohibited actions. The requirements
for laboratory investigations are explained, including: the actions to
take depending on the outcome of those investigations, the actions
that can be taken following retests, and the content of a deviation
investigation report in the laboratory are also described. This
instructor clarifies the requirements and limitations of out of trend
results, and outlier tests.
- Stability Studies (21 minute 40 Seconds)
- You can tell from the length of this presentation that the stability
program is no simple topic. This instructor breaks it down into simple
and easy to understand concepts. This presentation explains stability
from the drug substance, and the drug product perspective. The use of
the stability program to determine product expiration dates is
explained. This course simplifies: accelerated, long-term, and
intermediate stability studies, including testing frequency and data
submission requirements. Stress testing and stability studies for
specific climatic zones are made simple. Climatic zones are also
examined from long-term, intermediate term and accelerated study
requirements. Stability studies are also discussed for homeopathic and
allergenic extracts products. The terms primary batch, commitment
batches, and annual batch studies are also explained. Bracketed and
matrixed stability study designs are discussed as methods used to
reduce the costs associated with stability studies. Stability study
report requirements are also explained. The concept of a significant
change is explored.
- Reserve Samples (4 minutes 30 Seconds)
- Reserve samples are not stability samples, and vice-versa! This
presentation defines reserve samples, and describes the requirements
for reserve samples for active ingredients, finished drug product, and
- Wrap Up (0 minutes 58 Seconds)
- This presentation summarizes the Laboratory to Release topic.
Number of Quiz Questions: 32
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- Introduction (9 minutes 34 Seconds)
- This presentation introduces the topic, Proper Documentation
Practices, a review of the CGMP requirements in 21 CFR 211 - Subpart
J, and industry-wide documentation practices.
- This presentation explains many of the specific requirements for
good documentation practices. This presentation makes a distinction
between documents and records. The audit trail, employee
identification within the electronic record environment, and
preserving electronic data is discussed. General requirements for
paper-based records are also emphasized.
- CGMP Regulations (7 minutes 15 Seconds)
- Before all those crazy documentation rules can make sense, employees
must fully understand the regulatory requirements for a compliant
documentation system in a pharmaceutical manufacturing facility, as
explained by this experienced instructor. Additional FDA expectations
are explained, including: record inspection, photocopying of records,
record retention times, and acceptable record formats.
- Entry Practices (8 minutes 50 Seconds)
- Before putting pen to paper (or fingers to the keyboard, as the case
may be), know these rules. This presentation explains proper
documentation entry practices for all paper based and electronic
record environments. Learn the meaning of each employee's signature in
any record or on any document. Know the date and time formats used
most often. Be sure to know the proper handling of blank spaces.
Appreciate the importance of and rationale for checking your own work,
and the critical responsibility of checking other's work.
- Error Correction (5 minutes 0 Seconds)
- Making a documentation mistake need not be the end of the world, if
you follow these simple, but oftentimes forgotten rules. This
presentation explains, step-by-step, error correction practices as
used when documenting work in a single-performer and
multiple-performer task environments. Also explained are the needs and
information requirements for error corrections, and investigations
into errors or deviations prior to the release of product.
- Unacceptable Entry Practices (11 minute 15 Seconds)
- Learn to avoid committing any of these 10 deadly documentation
violations which may ultimately change your world in ways you'd like
to avoid. This presentation describes in clear detail the unacceptable
documentation practices all too frequently found in mostly paper-based
records. The rationale for considering these practices unacceptable is
explained, with emphasis on the required proper practices.
- Unacceptable Correction Practices (5 minutes 0 Seconds)
- If making a documentation mistake or improperly entering information
into a record isn't bad enough, this will surely ruin your day! Learn
to immediately recognize and avoid these unacceptable documentation
error correction practices. The preferred error correction practice is
- Electronic Records (10 minutes 47 Seconds)
- Almost everyone uses electronic records somewhere in manufacturing,
but did you know employees need to comply with so many rules? This
presentation explains the goals, common terms, and common activities,
within the electronic record environment. Special attention is given
to log-in procedures, signature record, maintaining the audit trail,
actions to prevent a system breach, and actions to take following an
attempted breach, archiving and copying records.
Number of Quiz Questions: 31
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