1.  Audit and Inspection - Starting with available in-house SOPs and applicable logs, audit is performed and the conditions evaluated according to current regs and inspection guidelines.  Remedies and solutions  presented.
    

2. cGMP Training - A 2 day full course with or without Audit and Inspection, covering most recent modifications to 21 CFR 210 and 211, case reports, What Ifs, compliance reports and evaluation by sample FD483s.  ICH relative approach.
    

3. Preparation/Assistance for PAIs - Internal Inspection reviewed.  Particular attention to CMCs, MVPs, EIR and Technology Transfer Documents.  Staff is briefed with regard to readiness for PAI and any deficiencies noted and remediated.

 
Technology / Protocol / Validation Arena

1. Protocols - Standardized protocols, or specific protocols (dosage form specific/therapeutic level specific) are written with or without follow-up for technology transfer/validation.
    

2. Instrument Qualification - Protocol (SOP) for OQ/PQ established, and performed as overall Lab effectiveness  evaluation.
    

3. Validations and Protocols - Setting protocols and evaluating and interpreting effective process (or method) validations.
    

4. Submissions - CMC, MVP preparation  reviewed and evaluated for completeness and effectiveness. Preparation assistance available.