FDA Guaranteed Certification and Online Training Courses :FDA GMP GLP HACCP ISO 14971, PMA, 510K, 483, FMEA FMEA MEDICAL DEVICES FDA/CGMP FDA/CGMP FOOD FDA/CGMP BLOOD

100% Success Rate 60-90 days*

CONSULTING TRAINING CERTIFICATIONS

FDA Compliance Steps

100% Success Rate

60-90 days*

Lowest Cost

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

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* based on Gap Assessment and if company follows all recommendations

Note: Quality University mark is a Registered Trade Mark of Quality University and should not be used without written approval of Quality University.

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