2. Game Instructions & Kits
You Bet! Game (US GMP version)
Description
What is it?
A multi-player/multi-team game intended for use in a classroom/instructor-led setting, to provide a review of basic GMP regulatory content knowledge.
Included in the game are questions on 21 CFR 210 & 211.
How does the game work?
The game is based on a team answering a content question, and remaining teams determining whether or not their answer was correct. Movement in the game is based on the accuracy of the teams’ answers.
Play as teams or as individual players — a minimum of 3 individual players, or 3 teams of 2 players each, up to 4 teams of 5 players each!
What’s included?
18 x 18” printed game board
Instructions for gameplay & scoring
5 player pieces
Wagering chips
30 & 60 second timers
180 questions, on printed plastic cards
Please note: We will do our best to keep copies of You Bet! in stock, but there may be a delay in shipping if we are awaiting a shipment from our printer. You will be advised of shipping dates at the time of your order if we can’t fulfill it immediately.
You Bet! Game (QSR version)
Description
What is it?
A multi-player/multi-team game intended for use in a classroom/instructor-led setting, to provide a review of basic medical device regulatory content.
Included in the game are questions on all subparts of the QSR, including design controls, and Medical Device Reporting (MDR) requirements for manufacturers.
How does the game work?
The game is based on a team answering a content question, and remaining teams determining whether or not their answer was correct. Movement in the game is based on the accuracy of the teams’ answers.
Customize the content by adding in the Design Controls and MDR (for manufacturers) content for the audiences for whom it’s appropriate.
Play as teams or as individual players — a minimum of 3 individual players, or 3 teams of 2 players each, up to 4 teams of 5 players each!
What’s included?
18 x 18” printed game board
Instructions for gameplay & scoring
5 player pieces
Wagering chips
30 & 60 second timers
Over 150 questions, on printed cards (132 QSR, 16 design control & 20 MDR questions)
Please note: We will do our best to keep copies of You Bet! in stock, but there may be a delay in shipping if we are awaiting a shipment from our printer. You will be advised of shipping dates at the time of your order if we can’t fulfill it immediately.
PDUFA Poker
Description
What Is It?
PDUFA Poker utilizes a poker game format to illustrate the fees associated with the Prescription Drug User Fee Act (PDUFA) and the need to invest in the business coupled with the inherent risks of doing so. Generic Drug User Fee Act (GDUFA) or Medical Device User Fee Act (MDUFA) information could be substituted if desired. This game highlights the fees paid, the importance of making wise investments, and the necessity for companies to manage finances to purchase supplies, pay salaries, and more.
The game requires approximately 15 minutes to complete and can be played by up to 20 people. Playing with larger audiences requires additional time to complete the game (up to another 15 minutes).
What’s Included?
The game is provided as a downloadable zip file that includes setup, play and facilitation instructions, instructions for content development, play money templates, poker hand ranking, and presentation slides for the activity.
Additional supplies required for this game are three decks of playing cards, laminating sheets, and small prizes.
Football Review Game
Description
What Is It?
This game conducts a review of content within the framework of a football game, and can be used on its own to provide a fully interactive training session. In this game, trainees form two competing teams discussing and responding to questions to gain yardage towards scoring touchdowns.
The game requires 2 hours to play a a full football game (four 15-minute quarters with a 10 minute break at halftime) as a standalone session. The ideal number of participants is 12-18 trainees — but it can be played with as few as 10 people or as many as 22.
What’s Included?
The game is provided as a downloadable zip file that includes setup, play and facilitation instructions, instructions for content development, templates for questions, and presentation slides for the activity.
Additional supplies required for this game are poker chips, duct tape, football goalposts, a whistle, sheet protectors, business card stock, and questions (at least 100 for a full football game).
A sampling of attendee feedback:
- “It made me think.”
- “Playing football was fun, and the questions made GMP training enjoyable and interesting. Working with teammates was the best part of the program.”
- “Great – making this fun and competitive makes the program and the information more memorable.”
- “Great way to get everyone involved – keep innovative ideas like this coming!”
- “The game kept everyone’s energy and interest up, and there was healthy debate instead of having something read to us. I had fun, and learned A LOT!”
- “Working as a team to come up with answers provided different views and ideas. Great way to get the messages across!”
- “Most valuable part to me was that everything was a real case from our business – it was very applicable to the work environment.”
- “Good format – enhanced interaction, exchange of ideas, and reinforced info with people having to speak it back. This was much better than sitting in front of slides – you don’t lose focus this way.”
- “This course highlighted real business issues and scenarios, and what we should or shouldn’t do when facing them.”
- “People from different organizations had to work together, and no one was put on the spot.”
The GMP Challenge! Game
Description
Compare to other currently available GMP training game kits costing up to $2500!
What is it?
Multi-player/multi-team game intended for use in a classroom setting, to provide a review of basic GMP content. Flexibility in play is designed into the game in the following ways:
Play as teams or as individual players — a minimum of 3 individual players, or 3 teams of 2 players each, up to 4 teams of 5 players each!
Use the included question content or substitute other questions in for one or more of the categories — can be used for years to come, and in several different courses simply by substituting question sets!
Customize the game length to fit your session — play a shorter, medium, or longer version of the game!
Teams can win either based on reaching the end of the game first, or by cumulative point total to keep the suspense until the very end of the game!
How does the game work?
Players move around the game board by rolling a die and answering a question of the type designated by the space on which they land. Questions cover all subparts of 21 CFR 211 in different formats. To add interest to the game, there are special spaces in which all teams are asked a question with the opportunity to win extra points, one team challenges another, and the opportunity for a team to steal a question another team misses to obtain even more points!
What’s included?
20 x 24” printed game board
Instructions for gameplay & scoring
5 player pieces
3 dice (4-sided, 6-sided & 10-sided)
30 second timer
Over 400 questions, on printed cards (multiple choice, true/false/yes/no, short answer, acronyms & GMP Challenge! questions)
What users of the game have said:
“Great review of GMP content in a fun and interactive format. Even the people who don’t like to participate enjoy this game. We’re looking forward to using this on a regular basis, with different question sets!”
“We’ve used this in several sessions, and everyone was involved and having fun.”
“We discovered even more ways that we can play, beyond the options provided in the game instructions — it’s a great, flexible format!”
“We want to make this an annual part of our GMP refresher program across all of our sites.”
“The depth, quality and quantity of content in this game is amazing!”
Please note: We will do our best to keep copies of The GMP Challenge! Game in stock, but there may be a delay in shipping if we are awaiting a shipment from our printer. You will be advised of shipping dates at the time of your order if we can’t fulfill it immediately.
Enforcement Hi-Lo
Description
What Is It?
Enforcement Hi-Lo illustrates and examines the various different types of enforcement actions issued annually by the Food & Drug Administration (FDA), and is designed to build perspective into trainees’ understanding of the FDA’s options for enforcement. It is best used to provide interaction in a training session for new hires after the enforcement actions have been explained, or as a review for more experienced personnel. This game may be used in conjunction with other activities or as a standalone activity.
The game requires approximately 15 minutes to complete and can be used with small groups by playing as individuals or with larger groups (up to 25 people) by playing as small teams.
What’s Included?
The game is provided as a downloadable zip file that includes setup and facilitation instructions, instructions for content development, and presentation slides that can be edited and used for the activity.
Additional supplies required for this game are small prizes, and laminating sheets/page protectors (if being used in a small group setting).
GMP Word Search Puzzles (pdf)
Description
Similar to our crossword puzzles, word searches are another great way to get people involved with the content of the GMPs.
This downloadable zip file contains a set of 12 word searches and their solutions. The puzzles use the content of 21 CFR 210 & 211, plus some common GMP definitions and terms. Each puzzle includes fill-in-the-blank clues to solve that provide the words to be found in the grid, as follows:
- GMP terms – 22 words
- 21 CFR 210 & 21 CFR 211 Subpart A – 15 words
- 21 CFR 211 Subpart B – 15 words
- 21 CFR 211 Subpart C – 17 words
- 21 CFR 211 Subpart D – 16 words
- 21 CFR 211 Subpart E – 16 words
- 21 CFR 211 Subpart F – 17 words
- 21 CFR 211 Subpart G – 18 words
- 21 CFR 211 Subpart H&K – 14 words
- 21 CFR 211 Subpart I – 20 words
- 21 CFR 211 Subpart J (1 of 2) – 20 words
- 21 CFR 211 Subpart J (2 of 2) – 17 words
Each puzzle includes the puzzle, fill-in-the-blank clues plus the content of the GMP subpart it’s based on. Distribute the word search and clues only, as a challenge for more advanced practitioners, or include the content of the regulations for those who need the content.
The GMP terms word search includes a list of words to choose from, including a couple of distractors to provide a challenge.
Use these puzzles to add some variety to your normal GMP training offerings, and involve your trainees in more effective learning!
QSR Word Search Puzzles (pdf)
Description
Word searches are a great way to get people involved with the content of the QSR!
This downloadable zip file contains a set of 21 word search puzzles and their solutions. The puzzles use the content of 21 CFR 820, plus some common definitions and terms. Each puzzle includes fill-in-the-blank questions as clues to solve that provide the words to be found in the grid, as follows:
Terms & definitions – 17 words
21 CFR 820 Subpart A – 18 words
21 CFR 820 Subpart B (1 of 2) – 18 words
21 CFR 820 Subpart B (2 of 2) – 15 words
21 CFR 820 Subpart C – 20 words
21 CFR 820 Subpart D – 13 words
21 CFR 820 Subpart E – 14 words
21 CFR 820 Subpart F – 9 words
21 CFR 820 Subpart G (1 of 2) – 23 words
21 CFR 820 Subpart G (2 of 2) – 15 words
21 CFR 820 Subpart H – 20 words
21 CFR 820 Subpart I – 17 words
21 CFR 820 Subpart J – 13 words
21 CFR 820 Subpart K – 13 words
21 CFR 820 Subpart L (1 of 2) – 18 words
21 CFR 820 Subpart L (2 of 2) – 12 words
21 CFR 820 Subpart M (1 of 3) – 14 words
21 CFR 820 Subpart M (2 of 3) – 16 words
21 CFR 820 Subpart M (3 of 3) – 18 words
21 CFR 820 Subpart N – 11 words
21 CFR 820 Subpart O – 10 words
Each puzzle includes the puzzle, fill-in-the-blank question clues plus the content of the QSR subpart it’s based on. Distribute the word search and clues only, as a challenge for more advanced practitioners, or include the content of the regulations for those who need the content.
The terms word search includes the definitions included in 21 CFR 820 Subpart A – along with a couple of terms that don’t appear in the QSR definitions to provide a challenge.
Use these puzzles to revitalize your GMP training offerings, and involve your trainees in more effective learning!
ISO 13485:2016 Word Searches (pdf)
Description
Word searches are a great way to get people involved with the content of ISO 13485:2016!
This downloadable zip file contains a set of 22 word search puzzles and their solutions. The puzzles use questions and wording based on the content of ISO 13485:2016. Each puzzle includes fill-in-the-blank questions to solve, and word lists that provide the words to be found in the grid, as follows:
Clauses 1 & 3: 12 questions/17 words
Clause 4.1: 17 questions/19 words
Clauses 4.2.1 – 4.2.3: 15 questions/17 words
Clauses 4.2.4 & 4.2.5: 20 questions/23 words
Clause 5: 2 puzzles, 13 questions/15 questions, 15 words each
Clause 6: 16 questions/25 words
Clauses 7.1 & 7.2: 17 questions/26 words
Clauses 7.3.1 – 7.3.3: 17 questions/25 words
Clauses 7.3.4 – 7.3.6: 16 questions/18 words
Clauses 7.3.7-7.3.10: 15 questions/18 words
Clause 7.4: 17 questions/17 words
Clauses 7.5.1, 7.5.2 & 7.5.5: 13 questions/16 words
Clauses 7.5.3 & 7.5.4: 10 questions/10 words
Clauses 7.5.6 & 7.5.7: 15 questions/15 words
Clauses 7.5.8 – 7.5.11: 16 questions/17 words
Clause 7.6: 13 questions/13 words
Clauses 8.1, 8.2.5 & 8.2.6: 13 questions/14 words
Clauses 8.2.1-8.2.3: 14 questions/14 words
Clause 8.2.4: 12 questions/12 words
Clause 8.3: 19 questions/19 words
Clauses 8.4 & 8.5: 21 questions/21 words
(Please note: The ISO 13485:2016 standard is copyrighted, and actual content is not reproduced, nor is a copy of the standard included with purchase. Please visit the ISO website to purchase the actual standard.)
Use these puzzles to revitalize your training offerings, familiarize personnel with the content of the revised standard, and involve your trainees in more effective learning!
GMP Crossword Puzzles (pdf)
Description
If you’re looking for a way to make your initial or refresher GMP training more interactive, crossword puzzles are a great way to get people involved with the content of the GMPs.
This downloadable zip file contains a set of 12 puzzles and their solutions. The puzzles use the content of 21 CFR 210 & 211, plus some common GMP definitions and terms. Each puzzle includes 14-22 clues to solve, as follows:
- GMP terms – 22 questions
- 21 CFR 210 & 21 CFR 211 Subpart A – 15 questions
- 21 CFR 211 Subpart B – 15 questions
- 21 CFR 211 Subpart C – 17 questions
- 21 CFR 211 Subpart D – 16 questions
- 21 CFR 211 Subpart E – 16 questions
- 21 CFR 211 Subpart F – 17 questions
- 21 CFR 211 Subpart G – 18 questions
- 21 CFR 211 Subpart H&K – 14 questions
- 21 CFR 211 Subpart I – 20 questions
- 21 CFR 211 Subpart J (1 of 2) – 20 questions
- 21 CFR 211 Subpart J (2 of 2) – 17 questions
Each puzzle includes the puzzle and clues plus the content of the GMP subpart it’s based on – you can distribute the puzzle and clues only, as a challenge for more advanced practitioners, or include the content of the regulations for those who need the content.
The GMP terms puzzle includes a list of words to choose from, including a couple of distractors to provide a challenge.
Use these puzzles to shake up your normal GMP training offerings, and involve your trainees in more effective learning!
QSR Crossword Puzzles (pdf)
Description
Crossword puzzles are a great way to get trainees involved with the content of the regulations!
This downloadable zip file contains a set of 21 crossword puzzles and their solutions. The puzzles use the content of 21 CFR 820, plus some common definitions and terms. Each puzzle includes fill-in-the-blank questions as clues to solve that provide the words to be found in the grid, as follows:
Terms & definitions – 17 words
21 CFR 820 Subpart A – 18 words
21 CFR 820 Subpart B (1 of 2) – 18 words
21 CFR 820 Subpart B (2 of 2) – 15 words
21 CFR 820 Subpart C – 20 words
21 CFR 820 Subpart D – 13 words
21 CFR 820 Subpart E – 14 words
21 CFR 820 Subpart F – 9 words
21 CFR 820 Subpart G (1 of 2) – 23 words
21 CFR 820 Subpart G (2 of 2) – 15 words
21 CFR 820 Subpart H – 20 words
21 CFR 820 Subpart I – 17 words
21 CFR 820 Subpart J – 13 words
21 CFR 820 Subpart K – 13 words
21 CFR 820 Subpart L (1 of 2) – 18 words
21 CFR 820 Subpart L (2 of 2) – 12 words
21 CFR 820 Subpart M (1 of 3) – 14 words
21 CFR 820 Subpart M (2 of 3) – 16 words
21 CFR 820 Subpart M (3 of 3) – 18 words
21 CFR 820 Subpart N – 11 words
21 CFR 820 Subpart O – 10 words
Each puzzle includes the puzzle, the fill-in-the-blank question clues plus the content of the QSR subpart it’s based on. Distribute the puzzle and clues only, as a challenge for more advanced practitioners, or include the content of the regulations for those who need the content.
The Terms puzzle includes the definitions included in 21 CFR 820 Subpart A, along with a couple of terms that don’t appear in the QSR definitions to provide a challenge.
Use these puzzles to revitalize your normal GMP training offerings, and involve your trainees in more effective learning!
What, Why & How Game
Description
What is it?
A multi-player/multi-team game intended for use in a classroom/instructor-led setting.
This game reviews basic operator compliance knowledge content, covering a variety of situations operators face – specifically targeting refresher content to operators and daily operations!
The game content spans operator knowledge applicable to both GMP & QSR operational environments – specific links are not made to regulations, instead, the what, why and how elements of daily operations are up for discussion.
Use the included questions and answers, or add additional questions or responses to address company specific situations and knowledge in the game.
How does the game work?
As teams, players answer questions and gain position for correct answers. All teams answer all questions, so no one is left sitting and waiting – everyone’s involved throughout the whole game.
Questions may have single, multiple or multi-part answers. Find out how much your operators know, and use any gaps as teaching moments.
Additionally, responses to the questions can be customized to meet your specific SOP content.
Play as teams or as individual players — a minimum of 2 players or teams, up to 4 teams of 5 players each!
What’s included?
18 x 18” printed game board
Instructions for gameplay & scoring
5 player pieces
Answering boards (dry erase boards, markers & erasers)
60 second timer
4-sided die
80 questions, on printed cards (categories identified by card color)
Please note: We will do our best to keep copies of What, Why & How in stock, but there may be a delay in shipping if we are awaiting a shipment from our printer. You will be advised of shipping dates at the time of your order if we can’t fulfill it immediately.