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FDA Compliance

100% Success Rate

60-90 days*    

Lowest Cost


 On Site Training    Customized Training      Internal Audit  Acquisition Audit  Supplier Audit  FDA Audit 

Our Customers

ISO 9001 AS 9100 ISO 14000 TL 9000 ISO 20000ISO 22000ISO 10002 TS 16949 ISO 13485 OSHAS 18001 93/42/EEC 98/79/EEC 90/385/EEC CMDCAS FDA CGMP TickIT HACCP Six Sigma Sarbanes-Oxley RoHS CMMI Sony Green Lean Mfg


Step 1
Prepare FDA Implementation Plan and Detailed Schedule Accelerate & Clients
+ Prepare FDA plan for the Quality System Development
(Accelerate will work with Client)
Step 2
FDA Gap Assessment
+ Perform the FDA Gap Assessment to Identify GAPS between the standard and what exist.
(Accelerate will prepare the report)
Step 3
FDA Training (Auditors)
+ 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
+ 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
+ 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
+ Define FDA Quality Objective with reference to Quality Policy.
(Accelerate will prepare working with Client)
Step 7
FDA Measurement Analysis & Improvement
(Define & Document)
+ Define FDA Measurement Analysis Process for continuous improvement.
(Accelerate will prepare working with Client)
Step 8
FDA Quality Planning (Define & Document)
+ Define FDA Quality Planning Process.
(Accelerate will prepare working with Client)
Step 9
FDA Executive Management Training
+ 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

+ 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)
+ 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)
+ 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
+ Document the FDA processes in detail if needed.
(Accelerate will work with Client)
Step 14
FDA Level I (Quality Manual)
Approval/Sign-Off Client
+ Have Top Management sign the FDA Quality Manual.
(Client works with Accelerate)
Step 15
FDA Level II (SOP)
Client & Accelerate
+ Have all FDA procedures approved by process owners and concerned functions.
(Client works with Accelerate)
Step 16
FDA Level III (Work Instructions)
Client & 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
+ 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
+ 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.)
+ 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
+ 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
+ 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
+ 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
+ Registrar (an independent certifying body) to perform FDA Pre-Assessment (Accelerate will support)
Step 24
FDA Corrective & Preventive Actions to registrar finding Accelerate & Client
+ Do close loop FDA corrective actions (same as STEP 18 & 21) (Client works with Accelerate)
Step 25
Accelerate Documentation Review for FDA
+ Accelerate Review the FDA complete system for compliance to standard.
Step 26
Accelerate Assessment for FDA
+ Accelerate perform FDA audit for identifying issues to related Implementation.
Step 27
FDA Corrective & Preventive Actions
+ Do close loop FDA corrective & preventive action for all issues raised (STEP 25 & 26)(Accelerate works with Client)
Step 28
Final FDA Registration Audit
+ Registrar perform the final FDA Registration Audit. (Accelerate will support)
Step 29
Prepare FDA action plan for registrar finding
+ Submit FDA Action Plan & close Registrar Findings.. (Accelerate works with Client)
Step 30
Client Certified
+ Accelerate FDA Registered Client in Accelerate Database as "Certified"
Step 31
FDA Maintaining Upgrade & Training
+ Accelerate will provide. (If desired)

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* based on Gap Assessment and if company follows all recommendations


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