CONSULTING TRAINING CERTIFICATIONS
d! 100% Success Rate 60-90 days
|
|
|
100% Success Rate 60-90 days*
CONSULTING TRAINING CERTIFICATIONS
|
FDA/CGMP Key Steps for Compliance
|
Step 1 Prepare FDA/CGMP Implementation Plan and Detailed Schedule Accelerate & Clients ACCELERATE |
+ Prepare plan for the FDA/CGMP Quality
System Development (Accelerate will work with Client) |
|---|---|
| Step 2 Gap Assessment FDA/CGMP ACCELERATE |
+ Perform the
FDA/CGMP Gap Assessment to Identify GAPS between the standard
and what exist. (Accelerate will prepare the report) |
|
Step 3 FDA/CGMP Training (Auditors) ACCELERATE |
+ Train the FDA/CGMP Internal Auditors and
Process Owners to the Standard. Upon passing the exam, process owner taking training will get qualified as Internal Auditor and Lead Auditor Accelerate will issue certificate. |
| Step 4 FDA/CGMP Implementation Training ACCELERATE |
+ Train
process owners to FDA/CGMP Implementation Process. (Accelerate will perform the activity) ISO will issue certificate on passing exam. |
|
Step 5 FDA/CGMP Quality Policy (Define & Document) Accelerate & Client ACCELERATE |
+ Define FDA/CGMP Quality Policy to
internal and external customers. (Accelerate will prepare Quality Policy working with Client |
| Step 6 Quality Objectives for FDA/CGMP (Define & Document) Accelerate & Client ACCELERATE |
+ Define FDA/CGMP
Quality Objective with reference to Quality Policy. (Accelerate will prepare working with Client) |
|
Step 7 Measurement Analysis & Improvement for FDA/CGMP (Define & Document) ACCELERATE |
+ Define FDA/CGMP Measurement Analysis
Process for continuous improvement. (Accelerate will prepare working with Client) |
| Step 8 FDA/CGMP Quality Planning (Define & Document) ACCELERATE |
+ Define FDA/CGMP
Quality Planning Process. (Accelerate will prepare working with Client) |
|
Step 9 FDA/CGMP Executive Management Training ACCELERATE |
+ Train FDA/CGMP Executive Management for
the process for Conducting Management Review. (Accelerate will issue certificate) |
| Step 10 Documentation of Data Control for FDA/CGMP
Hazard Analysis and Risk Assessment |
+ Define FDA/CGMP
Documentation and Data Control Process for development and Management of Documentation Control System. (Accelerate will develop, works with Client, which include infrastructure for Documentation Control) |
|
Step 11 Level I (Quality Manual for FDA/CGMP) ACCELERATE |
+ Prepare FDA/CGMP Quality Manual. Document the Company Policy in the manual for compliance to the standard. (Accelerate will prepare for Client) |
| Step 12 Level II (Standard Operating Procedures for FDA/CGMP) ACCELERATE |
+ Define the
process and the interaction between the processes. Document each process in compliance with the standard. (Accelerate will prepare with Client) |
|
Step 13 Level III (Work Instructions for FDA/CGMP) Draft Accelerate & Client ACCELERATE |
+ FDA/CGMP Document the processes in
detail if needed. (Accelerate will work with Client) |
| Step 14 Level I (Quality Manual for FDA/CGMP) Approval/Sign-Off Client ACCELERATE |
+ Have Top
Management sign the FDA/CGMP Quality Manual. (Client works with Accelerate) |
|
Step 15 Level II (SOP for FDA/CGMP) Approval/Sign-Off Client & Accelerate ACCELERATE |
+ Have all FDA/CGMP procedures approved by
process owners and concerned functions. (Client works with Accelerate) |
| Step 16 Level III (Work Instructions) Approval/Sign-Off Client & Accelerate ACCELERATE |
+ Have work
instruction signed-off by concerned functions. (Client works with Accelerate) |
|
Step 17 First FDA/CGMP Internal Audit (by qualified Internal Auditors) Client & Accelerate ACCELERATE |
+ Perform first FDA/CGMP Internal Audit.
This audit will be conducted by independent Internal Certified
Auditors. (Client will perform with support from Accelerate) |
| Step 18 FDA/CGMP Corrective & Preventive Actions, customer, vendor, quality Client & Accelerate ACCELERATE |
+ Do close
loop FDA/CGMP corrective and preventive action for all issues
including issues from Internal Audit (STEP 17). (Client will
perform with Accelerate) |
|
Step 19 FDA/CGMP First Management Review (Performed by Management Rep. & Executive Mgmt.) ACCELERATE |
+ Conduct FDA/CGMP Management Review as
per Management Review procedures. (Client works with Accelerate) |
| Step 20 Second Internal Audit (By Qualified Internal Auditors) Accelerate & Client ACCELERATE |
+ Perform
second Internal by Certified Internal Auditors (same as STEP
17). (Client works with Accelerate) |
|
Step 21 Corrective & Preventive Action for 2nd Internal Audit Accelerate & Client ACCELERATE |
+ Perform close loop corrective and
preventive action (Same as STEP 18). (Client works with
Accelerate) |
| Step 22 Second Management Review (By Executive Mgmt.) Client & Accelerate ACCELERATE |
+ Perform
Management Review as per Management Review Procedure (same as
STEP 19). (Client works with Accelerate) |
|
Step 23 Registrar Pre-Assessment (Optional Activity) Registrar Client & Accelerate ACCELERATE |
+ Registrar (an independent certifying
body) to perform Pre-Assessment (Accelerate will support) |
| Step 24 FDA/CGMP Corrective & Preventive Actions to registrar finding Accelerate & Client ACCELERATE |
+ Do close
loop FDA/CGMP corrective actions (same as STEP 18 & 21) (Client
works with Accelerate)
|
|
Step 25 Accelerate Documentation Review ACCELERATE |
+ Accelerate Review the complete system
for compliance to standard.
|
| Step 26 Accelerate Assessment ACCELERATE |
+ Accelerate
perform audit for identifying issues to related Implementation. |
|
Step 27 Corrective & Preventive Actions ACCELERATE |
+ Do close loop corrective & preventive
action for all issues raised (STEP 25 & 26)(Accelerate works
with Client) |
| Step 28 Final Audit for Compliance ACCELERATE |
(Accelerate
will support) |
|
Step 29 Prepare action plan ACCELERATE |
+ Submit Action Plan & close Registrar
Findings.. (Accelerate works with Client) |
| Step 30 Client Compliance ACCELERATE |
Project complete |
|
Step 31 FDA/CGMP Maintaining Upgrade & Training ACCELERATE |
+ Accelerate will provide. (If desired) |