1. The Integrated Development Training System TM

3. Contents 1. Executive Overview 2. Training System History 3. Understanding the Training System 4. Training System Process and Structure 5. Forecasting and Statistical Analysis

4. Executive Overview 1

5. 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

6. 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.

7. Training System History 2

8. 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

9. Project History Observations Listing Training as either the Corrective Action or the Deviation 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

10. Implementation Results Observations Pre and Post Training Quality 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

11. 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.

12. 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

13. Understanding the Training System 3

14. 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.

15. 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

16. 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

17. Training System Process and Structure 4

18. Training Process

19. Types of Training

20. Training Packages 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

21. Team Structure Full Time Permanent Training Department Full Time Permanent in Other Positions from All Departments

22. 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

23. Knowledge Transfer Course Developer Subject Matter Expert Subject Matter Expert (Junior) (Junior) Trainer Subject Matter Expert (Senior)

24. Roles and Responsibilities Course DeveloperSubject Matter ExpertsTrainers 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

25. Time Allocation

26. 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

27. 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

28. 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

29. Training Structure Job Specific (Read and Understand) New Training SystemOld Training System

30. Validation Structure Example

31. Training Transition New Training System Old Training System

32. Validation Structure Example New Training System Old Training System

33. 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 System Qualification Phase New Training SOP

34. Qualification by Training

35. Forecasting and Statistical Analysis 5

36. Training Evaluation Statistics 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

37. 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

38. Status Reporting of Teams Subject Matter Experts

39. Implementation Project Plan