Current Training and SOP Trends David A. Gallup, Ed. D. Principal Training and Communications Group, Inc.

1. Current Training and SOP Trends David A. Gallup, Ed. D. Principal Training and Communications Group, Inc.

2. Agenda • Background • What are the Training/SOP Requirements? • Current Training Methodology • Current SOP Methodology • Conclusions Agenda

3. Agenda • Background Agenda

4. Background • Personal • Training and Communications Group, Inc. Background

5. Agenda • Background • What are the Training/SOP Requirements? Agenda

6. What are the Training/SOP Requirements? • FDA regulates manufacturing, processing, packaging and holding of drugs in CFR • CFR contains two important sections: • Personnel Qualifications • Written Procedures • Latest Training Guidance • Quality Systems Approach to Pharmaceutical CGMP Regulations Requirements

7. CFR 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 practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Requirements

8. CFR 211.100 Written Procedures • There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. Requirements

9. Latest training guidance • Guidance for Industry • Quality Systems Approach to Pharmaceutical CGMP Regulations • Personnel Development Section Requirements

10. Quality Systems Approach to Pharmaceutical CGMP Regulations • . . . personnel should be qualified to do the operations that are assigned to them. . . • . . . managers should define appropriate qualifications for each position • . . . these personnel should be selected based on their scientific and technical understanding, product knowledge, process knowledge and/or risk assessment abilities. . . Requirements

11. Quality Systems Approach to Pharmaceutical CGMP Regulations • . . . continued training is critical to ensure that the employees remain proficient in their operational functions and in their understanding of CGMP regulations. • . . . training should address the policies, processes, procedures, and written instructions related to operational activities. . . • . . . training should focus on both the employees’ specific job functions and the related CGMP regulatory requirements. Requirements

12. Quality Systems Approach to Pharmaceutical CGMP Regulations • . . . managers are expected to establish training programs that include the following: • Evaluation of training needs • Provision of training to satisfy these needs • Evaluation of effectiveness of training • Documentation of training and/or re-training • . . . it is important that managers verify that skills gained from training are implemented in day-to-day performance. Requirements

13. In Summary: • Organizations must provide technical skill, GMP and procedural (Standard Operating Procedures or SOPs) training to their personnel. • Training should be developed and implemented in a systematic manner. Requirements

14. Agenda • Background • What are the Training/SOP Requirements? • Current Training Methodologies Agenda

15. Shadow or Follow Me Around Training Competency-Based Training Current Training Methodologies Training Methodology

16. Current Training Methodologies • Shadow or Follow Me Around Training • No structured development or implementation process • Employee to be trained observes experienced employee as he/she performs job. • New employee deemed “qualified” when experienced employee says so. • No structured evaluation. • Employee may learn bad habits—including incorrect procedures. Training Methodology

17. What can result from Shadow or Follow Me Around Training? • From a 483 Observation • “3. Failure to assure that personnel are adequately trained to perform assigned functions, as required by 21 CFR 820.25(b)., For example: • a. An untrained operator was assigned to assemble Clinitek 50 analyzers. Training Methodology

18. What can result from Shadow or Follow me around training? • From a Consent Decree Training Methodology

19. Current Training Methodologies • Competency-Based Training • Systematic identification of required skills or areas of knowledge to perform job • Systematic development of training materials to provide: • skill development and practice or • specific “bits” of information • Systematic implementation of the training materials • Evaluation to determine: • ability to perform discrete skill or task • ability to retain “bits” of information Training Methodology

20. Historical Precedent Training Methodology

21. Competency-Based Training Design Process Needs Analysis Situation Analysis Task Analysis Objective Specification Implementation Select, Design & Produce Training Materials Select, Design & Produce Evaluation Materials Training Methodology

22. Current Training Methodology • Self-instructional text with illustrations and quizzes provides knowledge • Written Evaluation to determine knowledge • On-the-Job Training Checklist guides demonstration and practice • Skill Checklist to determine ability to perform skill Training Methodology

23. What do the training materials look like? Training Materials-Instructor-Led Training Materials-Computer Based Written Evaluation Performance Evaluation Training Methodology

24. Advantages of Competency-Based Training • Self-instructional text provides up front/background information, reducing time needed for on-the-job training. • Can be used if no trainer is currently available. • On-the-job Training Checklist guides demonstration of critical skills, ensuring all personnel receive the same knowledge and skill in a consistent manner. • Written provides assurance employee has retained knowledge. • Skill based evaluation provide assurance employee can perform job function. Training Methodology

25. Agenda • Background • What are the Training/SOP Requirements? • Current Training Methodology • Current SOP Methodology Agenda

26. Read and Understand Read, Trained, Tested, (Competency-Based Training) Current SOP Methodologies Training Methodology

27. Procedure Definition • “established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations” • “How it will be done” SOP Methodology

28. Standard Operating Procedures (SOPs) • Describe how to perform various job tasks • Extend to tools, equipment and processes • Ideally provide step-by-step instructions • Considered written commitments to the FDA describing how a task will be done SOP Methodology

29. Policy Definition • “a definite course or method of action selected from among alternatives and in light of given conditions to guide and determine present and future decisions.” • “What will be done” SOP Methodology

30. Describe an “Effective” SOP • Clear • Accurate • Up-to-date • Easy-to-follow SOP Methodology

31. Why don’t SOPs meet these criteria? SOP Methodology

32. Standard Operating Procedures (SOPs) • SOPs should make it clear: • who will perform the task (responsibility) • why it will be performed (purpose) • how the task will be performed (procedure) • what limits of use apply (scope) SOP Methodology

33. Who Typically Writes SOPS? • Subject Matter Experts SOP Methodology

34. How could we do better? SOP Methodology

35. Consider the Visual SOP! SOP Methodology

36. What are Visual SOPs? • Step-by-step procedures that illustrates the job, process, or task. SOP Methodology

37. Visual SOPs Provide Users With… words and pictures, diagrams or drawings of process operations SOP Methodology

38. SOP Methodology

39. SOP Methodology

40. SOP Methodology

41. What do Visual SOPs look like? Training Methodology

42. SOP Methodology

43. SOP Methodology

44. SOP Methodology

45. Visual SOPs are essentially Job Aids • Job aids are prompters or guides for doing a task; for jogging the memory while performing a task. • A job aid can be placed at the job site and available when and where the user needs it. SOP Methodology

46. Advantages of this System • Job aids save organizations money • Job aids can be developed in 3 - 5 times less time than equivalent training programs • Job aids reduce training time • Research shows that job aids help inexperienced personnel outperform experienced personnel using more traditional reference materials SOP Methodology

47. Advantages of this System • Reading Proficiency • >50% of the procedures written on an 11th to 12th grade level • Learning Styles • A significant percentage of the population does not learn effectively by following written instructions. • They need to see what it is they are supposed to do SOP Methodology

48. The Future? • Visual SOPs Or • Combined Training and Visual SOPS SOP Methodology

49. Agenda • Background • What are the Training/SOP Requirements? • Current Training Methodology • Current SOP Methodology • Conclusions Agenda