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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:

  1. Do you need to conduct CGMP Training on a limited budget? 
  2. Do you want employees to learn the CGMPs from an expert using real examples? 
  3. Do you need CGMP Training resources suitable for multiple levels of the organization?

If you answered YES to any of these three questions then you should take a look at the courses below:

Click the topic listed for a course description

21 CFR 211: Pure, Safe and Effective - Subparts A-K  Plant to Production - Subpart F 
Your Personal Responsibilities - Subpart B Plant to Patient - Subpart G, H, & K 
Foundation to Facilities - Subpart C  Laboratory to Release - Subpart I 
Maintaining Compliant Equipment Practices - Subpart D  Proper Documentation Practices - Subpart J 
Supplier to Plant - Subpart E Download Course Description (PDF)

We Offer Two Approaches

Select the approach best suited for your site. Pricing varies. 

  1. Hosted Training - SkillsPlus will host your employees within our Learning Management System.
  2. 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 points. 
  • Flexible delivery schedule means less adverse impact to plant operations 
  • 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 agreement. 
  • Very affordable!

General Features of Either Approach 

  • Allan's 40 years of industry experience and knowledge is built into each training topic. 
  • 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.

General Uses

  • 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 revenue. 
  • Supplements your own instruction with examples that you can share with the live classroom. 
  • Used as a content resource as you develop your own in-house presentations. 
  • 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 designated individual. 
  • 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 training. 
  • 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!

Collateral Materials

  • 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 content. 
  • 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 system.
  • 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 Services below.

Collateral Materials

  • 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 this.
  • 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 service.
  • 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 published version.
  • 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.

21 CFR 211: A New Generation (63 Minutes)

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.

Topic Presentations: 

  • 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

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Your Personal Responsibilities: Subpart B (77 Minutes)

Topic Presentations:

  • 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)  
    • Although 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 Seconds)  
    • A 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.
  •  History 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)  
    • This 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.  
  • Gowning (8 Minutes 6 Seconds)
    • Working in a pharmaceutical manufacturing facility, regardless of the department, requires unique gowning 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)  
    • Almost 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

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Foundation to Facility: Subpart C (92 Minutes)

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. 

Topic Presentations:

  • 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 Seconds)
    • 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 products.  This 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 considerations. 
  • 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 control. 
  • 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

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Maintaining Compliant Equipment Practices: Subpart D (51 Minutes)

Topic Presentations:

  • 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 presentation.
  • 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 pharmaceutical industry.
  • 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 detail.
  • 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

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Supplier to Plant: Subpart E (57 Minutes)

Topic Presentations: 

  • 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 is discussed.
  • 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

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Plan to Production: Subpart F (67 Minutes)

Topic Presentations:

  • 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 Process Controls
  • 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 regulatory requirements.
  • 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 for Revalidation.
  • 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

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Plant to Patient: Subparts G, H & K (49 Minutes)

Topic Presentations:

  • 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 products.
  • 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 investigations.
  • 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 period.
  • 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

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Laboratory to Release: Subpart I (74 Minutes)

Topic Presentations:

  • 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 Controls
  • 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 combination products.
  • Wrap Up (0 minutes 58 Seconds)
    • This presentation summarizes the Laboratory to Release topic.

Number of Quiz Questions: 32

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Proper Documentation Practices: Subpart J (58 Minutes)

Topic Presentations:

  • 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 emphasized.
  • 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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Current Good Manufacturing Practice Training: A New Generation Series by SkillsPlus International Inc.

For a prompt reply to requests and questions:  (415) 948-5220 |  Allan.Dewes@SkillsPlusInc.com 

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