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