Accessible record, 278

Adaptive design, 299

ADDIE, 109–112, 269

Adverse event, 9, 23–26, 51

Authorized record, 277–346

Awareness training, 197–201, 218, 220

Backed-up system, 276

Bioburden, 47–49, 59, 85, 91, 92, 98, 99

Business owner, 15, 16, 125, 157, 183, 206, 211, 321, 332

Business risk assessment, 169, 188, 220

Calibration, 10, 39, 40, 53, 54, 61, 66–76, 80, 101, 292

CAPA, (corrective acton/preventive action), 8, 13–15, 20–24, 29, 32–34, 37, 41, 45–50, 53, 54, 60, 64, 66–68, 73–76, 79, 81, 103, 124, 133, 153, 155, 169, 231, 239, 322, 326, 327, 334

Captured record, 276

cGMP, 31, 33, 101, 104, 144, 160, 167–173, 175–179, 181, 182, 184–189, 191, 192, 198, 199, 265, 324, 335

Change management, 53, 67, 74, 75, 330

Cleaning, 39, 47–49, 59, 60, 85, 91–93, 96–101, 179, 190, 207, 212, 279, 280, 292, 325, 326

Complete record, 277

Complexity, 15, 53, 54, 60–65, 67, 78, 103, 105, 146, 147, 150, 170, 175, 197, 198, 201, 217, 219, 246, 269

Comprehensive record, 277

Conditions of performance, 229, 234

Consistent system, 273

Continuing GMP training, 167–192

Continuous feedback of evaluative findings, 299, 303

Controlled document, 11, 14, 55, 227, 283, 285, 321, 326, 329, 330, 333, 334, 338

Criteria for successful performance, 229, 233, 235, 245

Critical procedures, 197

Critical review, 15, 54–63, 68, 73, 74, 76, 79, 103

Criticality, 15, 54, 60–68, 78, 103, 105, 170, 175, 197, 198, 216–219

Customer quality complaint, 23, 27, 29

Deviation investigation, 37, 65, 88, 326, 329

Disappearing training intervention, 252, 257

Elixir sulfanilamide, 152

Employee disqualification, 198, 219

Employee qualification, 104, 105, 197, 198, 203, 206, 210, 211, 215–219

Employee requalification, 198, 219

Employment life cycle, 138 -142, 158

Escalation, 37, 40, 50, 147, 149, 150

Exportable record, 278

Facilitating conditions, 252

FDA, 6, 7, 8, 10, 11, 12, 17, 18, 19, 21, 22, 23, 24, 25, 26, 27, 29, 30, 31, 33, 34, 41, 50, 56, 64, 68, 69, 70, 71, 72, 75, 76, 77, 80, 92, 96, 104, 113, 116, 119, 121, 132, 137, 138, 141, 143, 145, 146, 148, 150, 151, 152, 155, 156, 157, 159, 161, 163, 168, 171, 172, 173, 174, 178, 181, 182, 184, 185, 187, 189, 190, 191, 192, 198, 199, 200, 218, 219, 220, 221, 222, 226, 227, 230, 235, 268, 276, 277, 278, 279, 281, 282, 283, 284, 290, 293, 294, 295, 299, 309, 310, 311, 314, 317, 321, 323, 324, 325, 326, 327, 328, 331, 337, 339

Feedback, 109, 237, 252, 253, 264, 266, 299, 301, 303, 304, 305, 313, 316

Final implementation, 227, 253, 300, 301, 315, 321–323, 338

Formative evaluation, 109, 226, 252, 253, 268, 299–317, 322

GMP, 6, 10, 14, 22, 26, 28, 29, 30, 32, 37, 38, 39, 40, 48, 55, 69, 79, 85, 98, 101, 104, 117, 118, 121, 123, 124, 144, 157, 159, 160, 167, 168, 172, 173, 174, 175, 176, 184, 186, 188, 189, 190, 191, 192, 210, 221, 222, 232, 241, 247, 265, 266, 267, 268, 279, 280, 293, 325, 330, 334, 335

GMP zones, 85, 98

Good documentation practices, 85, 94

Human error, 37, 43, 176, 232, 327

Individual training plan, 206

IQ (installation qualification), 197, 209, 214, 221, 222

Ishikawa diagram, 37, 41, 197, 213, 216

ITP (individual training plan), 229, 231, 268, 274, 321

JITT (Just in time training), 321, 322

Jungle (Upton Sinclair's book), 138, 151, 15

KTA (knowledge transfer assessment), 115, 127, 129, 201, 203, 204, 206, 218, 229, 238, 239, 242, 245

Maintained record, 277

Measure of performance, 234

Memory, 203, 204, 205, 221, 255

NEO (new employee orientation), 137–163, 198

NoE (notice of event), 38, 40, 88, 90, 124, 148, 169, 330

Obstacles to implementation, 257, 258

OQ (operational qualification), 197, 209, 210, 214

Overview training, 109, 206

Part 11 compliance, 273, 278–284, 293

Performance gap, 109, 111, 112, 131, 231, 322

Pilot implementation, 109, 225, 238, 251–257, 259–264, 266, 268, 299–301, 322

Pilot project, 254, 313

PQ (performance qualification), 197, 209, 210, 214

Predicate rule, 31, 211, 279–281, 282, 283, 294

Procedure, 8, 9, 11, 12, 14, 15, 16, 17, 18, 20, 22, 30, 31, 43, 44, 53, 54, 55, 56, 57, 58, 59, 60, 62, 63, 64, 66, 67, 68, 71, 72, 73, 74, 75, 76, 77, 85, 86, 87, 88, 91, 93, 97, 98, 101, 104, 111, 116, 117, 118, 119, 120, 121, 126, 127, 148, 150, 168, 169, 174, 175, 182, 191, 192, 197, 198, 203, 206, 208, 211, 213, 216, 217, 219, 225, 227, 232, 233, 240, 246, 247, 274, 276, 278, 283, 285, 322, 323, 324, 326, 329, 330, 332, 333, 334, 335, 337, 338, 339

Process of qualification, 197, 209, 213

Program improvement, 109, 112, 119, 125, 130, 131, 227, 251–254, 264, 266, 268, 299–303, 305, 313, 314, 322

Program logic model, 47, 49

Qualification of SMEs, 175, 187, 198, 205, 219

Qualification of trainers, 175, 176, 187

Qualified individuals, 172–174, 177, 186, 187

Quality risk assessment, 169, 170, 188, 220

RCT (Randomized clinical trial) 299, 304–310, 312

Read and sign, 197

Real world challenge, 73

Regulatory inspection, 23, 33

Regulatory overlap, 33, 104, 121, 132, 137, 146, 159

Reinforcement training, 186

Remediation, 8, 14, 18, 22, 24, 27–33, 46, 47, 72, 104, 153, 156, 157, 174, 182, 197, 225–227, 239, 259, 326, 327, 328

Responsible (party), 9, 11, 18, 19, 20, 21, 28, 43, 47, 55, 57, 65, 74, 75, 86, 87, 96, 103, 104, 143, 147, 149, 158, 162, 183, 203, 218, 222, 240, 279, 281, 283, 285, 325, 333

Responsible system, 276

Re-training, 183, 200, 232, 326–328

Retrievable record, 278

Risk assessment, 53, 54, 60, 63, 76, 104, 167–175, 187, 217

RCA (root cause analysis), 7, 12, 20, 21, 24, 29, 32, 37–50, 103, 104, 105, 137, 153, 154, 159, 167, 174–177, 183, 187, 191, 198, 213–219, 231, 327

Safety precautions, 86

Salmonella contamination, 138, 151, 153, 156

Sanitizing, 47–49, 58, 59, 85, 91–101, 114, 206, 212, 234, 235

Scalable, 109

Scale up, 252

SDA (skill demonstration assessment) 75, 115, 127, 129, 130, 197, 201–206, 211, 212, 219, 229, 238–241, 295

Shifting training audience, 252, 257, 258

Sinclair, Upton, 138, 151, 161, 162, 204

SISPQ, 7, 10, 15, 19, 21, 23, 78, 92, 96–99, 169, 170, 175, 210, 280, 325

Situational judgment test, 229, 241

Skills training, 109, 206, 325

SOP (standard operating procedure), 2, 3, 4, 5, 8, 9, 10, 11, 14, 15, 16, 17, 18, 19, 20, 22, 23, 24, 27, 29, 31, 38, 39, 43, 50, 53, 54, 55, 56, 58, 60, 62, 67, 68, 69, 71, 73, 74, 77, 79, 85, 86, 87, 88, 93, 97, 98, 101, 103, 104, 111, 113, 115, 116, 120, 123, 124, 125, 127, 128, 130, 146, 148, 149, 158, 168, 175, 178, 182, 189, 206, 210, 211, 212, 233, 237, 240, 244, 265, 275, 277, 280, 285, 286, 295, 321, 322, 326, 329, 330, 331, 332, 333, 334, 335, 337

Stakeholders, 6, 29, 30, 316

Summative evaluation, 109, 252, 253, 300, 301

Target audience list, 127, 128, 321–338

Testing security, 229

Thalidomide, 138, 151–155, 162, 163

Trainee performance, 129, 203, 210, 229–238, 242, 245, 258

Trainee proficiency, 203, 225, 229, 230, 287, 295

Training audience, 111, 127, 128, 130, 171, 181, 182, 229, 233, 235, 245, 258, 260, 332, 334–337

Training curriculum, 109, 112, 115, 207, 322

Training event, 115, 130, 176, 177, 204, 206, 220, 229, 236–238, 244, 260, 261, 277, 283–285, 289, 307

Training outline, 104, 110, 125–131, 225, 227, 232, 260, 322, 332–338

Triage, 19, 26, 28, 38, 154

Tylenol poisoning, 138

Usable record, 278

Variable implementation, 252, 257, 258

Warning letter, 24, 71, 72, 80, 181, 190, 276–278, 324, 326, 332, 339

Work sampling, 229, 230, 242, 245