The Integrated Development
Training System TM
Contents
1. Executive Overview
2. Training System History
3. Understanding the Training System
4. Training System Process and Structure
5. Forecasting and Statistical Analysis
Executive Overview
1
Overview
The Integrated Development Training System:
Creates a self-sustaining site-wide training department and human resource pool that is more effective, efficient, and more compliant than a traditional training department
Reduces expense (in maintenance and compliance costs) compared to a traditional training department
Removes dependence on outside consultants by creating in-house expertise ─ the key differentiator between the Training System and the typical compliance training offered by other companies
Contains all of the materials, equipment, and supplies required for the System to function successfully ─ including implementation consulting ─ for one price
Key Success Factors
Standardizes training programs to achieve corrective and preventive actions resolution.
Specializes in pharmaceutical and biotechnology firms.
Empowers the greatest asset – your people.
Customizes development with a compliance readiness focus.
Equips the company with the necessary tools to become action oriented.
Evaluates the past training required for personnel.
Evaluates the types of training required for future success.
Specifies and verifies qualifications of trainers and course developers.
Produces approved and controlled training materials.
Clearly defines responsibilities.
Defines training record requirements.
Verifies ability of trainee to demonstrate knowledge and/or perform tasks.
Forecasts and reports status of training team and staff development.
Eliminates training resources deficiencies.
Training System History
2
Training System History
The Integrated Development Training System US Patent-pending Business Methodology Implemented to support the Training Quality System Supports the FDA’s guidance for Quality Systems
Project History
Observations Listing Training as either Observations Listing Training as either the Corrective Action or the Deviationthe Corrective Action or the Deviation
Observations Citing Training
2002
684
0
500
1000
1500
2000
2500
Total 2002 Observations Training Observations
Reason for the Training System:
CMO facility with a Warning Letter from the FDA
2002 combined total observations cited
684 of those observations cited training as an issue
Implementation Results
Observations Received Pre and Post Training Quality System Implementation
2002
100
500
1000
1500
2000
2500
Total 2002 Observations Total 2003 Observations
Observations Pre and Post Training Observations Pre and Post Training Quality System ImplementationQuality System Implementation
Results of the Training System:
Four subsequent FDA audits
Zero training-related observations
Observations reduced from a total of 2002 to a total of 10
FDA-proposed Pharmaceutical Quality System Design
Quality System Support:
The courses developed as a result of the Integrated Development Training System are the foundation for the implementation of the quality systems.
Quality Systems are mandatory control elements for both medical device manufacturers (Title 21 Part 820 of the U.S. Code of Federal Regulations [21CFR820]) and the biotechnology industry.
In August 2002… the FDA explained the Agency’s intent to integrate quality systems and risk management approaches into existing programs with the goal of encouraging the adoption of modern and innovative manufacturing technologies.
1. Training Management
2. Validation Management
3. Supplier Quality Management
4. Change Control Management
5. Deviation Management
6. Equipment and Facilities Management
7. Quality Attributes Management
8. Documentation Management
9. Computer Systems Management
10. Purchase, Receipt, Storage, and Delivery Management
Example: 20 Basic Quality Standards
11. Production Management
12. Audit Management
13. Material and Product Lot Disposition
14. Complaint Handling
15. Stability Studies
16. Technology Transfer
17. Research & Development Management
18. Annual Product Review
19. Quality Oversight
20. Recall Management
Understanding the Training System
3
Supporting cGMP regulations
21 CFR Part 211 – Organization and Personnel
Subpart B, section 211.25 - Personnel Qualifications (a) Each person engaged in the manufacture, processing, packing, or holding of a
drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s function. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports to possess.
Subpart B, section 211.34 - Consultants Consultants advising on the manufacture, processing, packing, or holding of drug
products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.
Why is Training Critical to Success?
Allows employees to operate effectively, efficiently and confidently
Reduces errors
Helps people understand the process as well as the task
Maintains compliance with regulatory agencies
Advantages of the Training System
Improve cost, quality, retention of and service to the customers
GMP compliance
Faster training curve
Fewer deviations and greater efficiency
Faster release of batches (increased accuracy and efficiency, better documentation)
Better troubleshooting (Subject Matter Experts)
Overhead reduced
Training System Process and Structure
4
Training Process
Monitoring of Training
Training Execution
Establishment of aTraining Plan
Assessment of TrainingNeeds
Need to Perform a GMP-related Activity
Selecting andDesigning Training
Methods
Conducting Training
Assessment of Training
Reporting of Training
Self-Paced
Awareness Only
Instructor-Led
On the Job (OJT)
Not JobCritical
JobCritical
Types of Training
Self-Paced Instructor-Led
- Training event is led by a qualifiedtrainer and uses a training package.
- Material is job-critical and willtypically include a knowledge orskills assessment.
- EXAMPLE: Trainer QualificationCourse
- Computer-based or Web-based
- Formerly “Read andUnderstand”
- EXAMPLE: Site FoodPolicy
Awareness Only
- Material presented is either notjob-critical or not a significantdeparture from standard procedure.
- Lecture for a large group
- Typically uses a PowerPointpresentation
- EXAMPLE: Announcementregarding a small change to anSOP during team meeting atbeginning of shift
On the Job(OJT)
- Hands-on, kinesthetic
- Training occurs at the jobsite and incorporates ademonstration of the job tobe performed
- EXAMPLE: Operating anHPLC
Training Packages
Assessment
Peripherals
Participant’s Manual
Training Package
Documentation ofQualification
Videos, PowerPointPresentation
Educational Material:- Linked to SOPs/Regulations- Support of Learning Styles
Training Packages:
Developed by Course Developers
Subject Matter Experts provide knowledge and experience
Approved and controlled documents
Delivered by Qualified Trainers
Ensure consistency and continuity in knowledge transfer
Team Structure
Site TrainingManager
CourseDeveloper
CourseDeveloper
Trainer
Power User / SME(Junior)
CourseDeveloper
TrainingDirector
Site TrainingCoordinator
Power User / SME(Senior)
Full Time Permanent Training Department
Full Time Permanentin Other Positions from All Departments
Team Structure
Resourcing Teams for the Training System:
Employees are “loaned” from their permanent job function
Amount of time required for training functions varies by demand
Every department is required to provide resources for training teams
Transfer of knowledge
Knowledge Transfer
Course DeveloperCourse Developer
Subject Matter ExpertSubject Matter Expert (Junior)(Junior)
TrainerTrainer
Subject Matter Expert Subject Matter Expert (Senior) (Senior)
Roles and Responsibilities
Course Developer Subject Matter Experts Trainers
Qualities Detail oriented
Comfortable with public speaking
Good writing skills
Ability to manage time and challenging deadlines
Good writing skills
Subject matter expertise
Comfortable with public speaking
Good presentation skills
Bilingual
Responsibilities Develop courses on various Basic Quality Standards (BQSs) and subsequent training packages to support new Training Quality System
Deliver training on BQSs, SOPs, and related training packages
Provide content for training packages
Assist course developers in developing training packages
Deliver training on BQSs, SOPs, and related training packages
Time Commitment 100% of hours for 1 month
50% of hours for 1 month
25% of hours for 1 month
approximately 10% for following months
15% of hours for 2 weeks
10% for 1 month
5% for 1 month
approximately 5% for following months
As needed
Time Allocation
Course Developers: Percentage of Time Allocated to
Training Development
0%20%40%60%80%
100%120%
Janu
ary
April
July
Octobe
r
Janu
ary
April
July
Octobe
r
Janu
ary
April
July
Octobe
r
January 2002 - December 2004
Tim
e
Standard JobResponsibilities
Time Dedicated toCourseDevelopment
Responsibilities
Defined in Training Management BQS
Generally speaking, as follows:
Area management is responsible for insuring: their personnel are appropriately trained
training is properly resourced and scheduled
proper training is indicated for each employee
Responsibilities (cont.)
Employee is responsible for insuring they: properly prepare for training Actively participate in training Attend the entire training and dedicate that time
strictly to training Provide feedback to improve the training system
Quality Assurance Oversight of the training program Periodic monitoring of the program for compliance
Responsibilities (cont.)
Course Developers Act as expert in production of training material Ensure proper material and methods are used for any
given training Work with trainer to insure trainee needs are met
Qualified Trainers Appropriately prepare for training Communicate expectations for trainings Evaluate and document trainee status Work with course developer to insure trainee needs
are met
Training Structure
Site Overview
Site Overview
Area SpecificArea Specific
Job SpecificJob Specific
Job Specific(Read and Understand)
Job Specific(Read and Understand)
New Training SystemOld Training System
Validation Structure Example
Validation SiteOverview
(BQS)
ComputerValidation
Equipment andFacilitiesValidation
ProcessValidation
SOP-1
OJT
SOP-2 SOP-3
AnalyticalMethods
Validation
Training Transition
Site Overview
Site Overview
Area SpecificArea Specific
Job Specific(Read and Understand)
Job Specific(Read and Understand)
New Training System
Old Training System
Validation Structure Example
Validation SiteOverview
(BQS)
ComputerValidation
Equipment andFacilitiesValidation
ProcessValidation
SOP-1
OJT
SOP-2 SOP-3
AnalyticalMethods
Validation
New Training System
Old Training System
Training Transition
Full transition to the new training system within one year
During the overlap period, Course Developers, Trainers, and SMEs are trained (and will continue being trained and qualified)
New Training System
Old Training SystemQualification
Phase
New Training SOP
Qualification by Training
Management of Productionby Qualified Personnel
Training Requirements areMet Over Time
Exempt from Training(Qualified by Education or Experience):
- SOP Author- SME- Course Developer / Trainer
Forecasting and Statistical Analysis
5
Training Evaluation Statistics
Block 1 BQS (cumulative)
0.00
1.00
2.00
3.00
4.00
Ove
rall
Lang
uage
Cou
rse
Inst
ruct
or
Training Evaluation Summary Areas
Evaluation Results:
4 = very good3 = good2 = sufficient1 = poor0 = no response
17-Nov-03
18-Nov-03
2-Dec-03
Training Evaluation Statistics – Tracking and Trending:
Monitors employee response to training design and delivery
Involves participants with training as change management agents
Monitors trainer performance over time
2 December 2003Classes Delivered in English
Anglophones, 21, 24%
Francophones, 56, 66%
Other, 9, 10%
Anglophones
Francophones
Other
2 December 2003Classes Delivered in French
Anglophones, 3, 3%
Francophones, 78, 86%
Other, 10, 11%
Anglophones
Francophones
Other
3 December 2003Classes Delivered in English
Anglophones, 24, 19%
Francophones, 83, 67%
Other, 17, 14%
Anglophones
Francophones
Other
4 December 2003Classes Delivered in French
Anglophones, 2, 2%
Francophones, 74, 87%
Other, 9, 11%
Anglophones
Francophones
Other
Class Population Statistics
Class Population Statistics –Trending and Analysis:
Determines population learning needs for schedule forecasting (especially in bilingual facilities)
Provides employees with learning experiences targeted to their learning styles and preferences
Monitors changes in population self-perception of knowledge, skills, abilities, and experience over time
Status Reporting of Teams
Montreal Course Developers, Trainers, and Power Users
20 20 20
21
5
21
5
0 0
4
0
5
10
15
20
25
Course Developers Trainers Power Users
Expected Identified Trained Qualified
Subject Matter Experts
Subject Matter Experts
Implementation Project Plan
ID Task Name
1 Biologics Quality Standards Implementation
2 Project Kickoff and Prep
3 Group 1 BQS
409
410 Group 2 BQS
411 Group 2 - Deliver Training QS Qualification Training
412 Course Development 101 Class - Group 2
413 Power User / SME Class
414 Train The Trainer
415 7.) Quality Attributes Assessment QS - Develop Trng. Pkg.
476 8.) Documentation Management QS - Develop Trng. Pkg.
537 9.) Production Management QS - Develop Trng. Pkg.
598 10.) Purchase, Receipt, Storage and Distribution QS - Develop Trng. Pkg.
659 Group 2 - Deliver BQS Overview Training to Site
680 Group 2 - Training Implemented to Site
681 Group 2 - Assess Qualification / Competency
682 Course Developers
688 Trainers
692 Power Users
694
695 Group 3 BQS
1040
1041 Group 4 BQS
1386
1387 Project and System Transition
1428
1429
34%
10/1
98%
79%
60%
100%
0%
0%
90%
89%
89%
89%
0%
1/16
0%
0%
0%
0%
0%
0%
0%
27 30 3 6 9 12 15 18 21 24 27 30 2 5 8 11 14 17 20 23 26 29 2 5 8 11 14 17 20 23 26 29 1 4 7 10 13 16 19 22 25 28 31 3 6 9 12 15 18 21 24 27 1 4 7 10 13 16 19 22 25 28 31 3 6 9 12 15 18 21 24 27 30 3 6 9 12 15 18 21 24 27 30September 2003 October 2003 November 2003 December 2003 January 2004 February 2004 March 2004 April 2004 May 2004 June 2004
ID
1
2
3
409
410
694
695
1040
1041
1386
1387
1428
34%
10/1
98%
79%
0%
0%
0%
6 9 12 15 18 21 24 27 30 2 5 8 11 14 17 20 23 26 29 2 5 8 11 14 17 20 23 26 29 1 4 7 10 13 16 19 22 25 28 31 3 6 9 12 15 18 21 24 27 1 4 7 10 13 16 19 22 25 28 31 3 6 9 12 15 18 21 24 27 30 3 6 9 12 15 18 21 24 27 30October 2003 November 2003 December 2003 January 2004 February 2004 March 2004 April 2004 May 2004