Exercise instructions 25 September 2020 Page 1 Instructions

Exercise instructions 25 September 2020 Page 1

Instructions – Self assessment exercise Ø The group will be divided into teams based on the total number. Ø Each team will be assigned a list of PQs to complete the selfassessment on. Ø Teams, on the template provided : • • • Read the PQs; Understand the guidance for review of PQ; Provide the status of implementation; and Identify detailed evidence with notes for each step of the guidance. Save the completed form by team name and the PQ number. Ø Teams must select one or more members to present their answers to the remainder of the group on the screen. 25 September 2020 Page 2 2

Self assessment exercise – List of PQs LEG ORG PEL OPS AIR AIG ANS AGA LEG 1. 001 (CE-1) ORG 2. 021 (CE-3) PEL 3. 003 (CE-2) OPS 4. 037 (CE-1) AIR 5. 001 (CE-2) AIG 6. 003 (CE-1) ANS 7. 001 (CE-1) AGA 8. 057 (CE-4) LEG 1. 025 (CE-2) ORG 2. 053 (CE-3) PEL 3. 105 (CE-3) OPS 4. 041 (CE-3) AIR 5. 033 (CE-3) AIG 6. 011 (CE-2) ANS 7. 007 (CE-2) AGA 8. 001 (CE-2) LEG 1. 051 (CE-1) ORG 2. 101 (CE-4) PEL 3. 311 (CE-4) OPS 4. 059 (CE-4) AIR 5. 053 (CE-4) AIG 6. 105 (CE-3) ANS 7. 031 (CE-3) AGA 8. 211 (CE-6) LEG 1. 105 (CE-3) ORG 2. 201 (CE-5) PEL 3. 303 (CE-5) OPS 4. 109 (CE-6) AIR 5. 203 (CE-7) AIG 6. 131 (CE-4) ANS 7. 065 (CE-4) AGA 8. 287 (CE-6) PEL 3. 469 (CE-7) OPS 4. 131 (CE-2) AIR 5. 233 (CE-5) AIG 6. 323 (CE-5) ANS 7. 361 (CE-5) PEL 3. 609 (CE-8) OPS 4. 141 (CE-5) AIR 5. 333 (CE-6) AIG 6. 501 (CE-8) ANS 7. 169 (CE-6) PEL 3. 751 (CE-6) OPS 4. 253 (CE-7) AIR 5. 445 (CE-8) OPS 4. 371 (CE-8) 25 September 2020 ANS 7. 393 (CE-7) ANS 7. 045 (CE-8) Page 3

Instructions – Manage Corrective Action Plan Ø The group will be divided into teams based on the total number. Ø Each team will be assigned one or more Protocol Findings in order to develop their CAPs. Ø Teams, on the template provided: • • • Read the PQ and identify a related CE; Understand the Protocol Finding; Develop their CAP in a step-by-step method; and Identify the action office and the EID for each step. Provide detailed evidence with notes for each step of the guidance. Save the completed form by team name and the PQ number. Ø Teams select one or more members to present their answers to the remainder of the group on the screen. 25 September 2020 Page 4 4

Corrective Action Plan– List of PQs LEG ORG PEL OPS AIR AIG ANS AGA LEG 1. 001 ORG 2. 011 PEL 3. 309 OPS 4. 091 AIR 5. 127 AIG 6. 133 ANS 7. 287 AGA 8. 311 ANS 7. 201 AGA 8. 163 ANS 7. 517 AGA 8. 257 ANS 7. 153 AGA 8. 261 25 September 2020 Page 5