Classroom Training

IPM has been successfully conducting training programmes in Mumbai, with its presence in Dombivli, Borivali & Vashi.

Salient features are:
  • Course curriculum based on current approach of regulatory agencies
  • Sunday batches, so good option for working professionals
  • Experienced industrial faculties
  • User-friendly notes based on current guidelines
  • Explanation with case-studies
  • Group discussion & Quiz sessions
  • Evaluation & certification

Diploma in Analytical Data Review

Eligibility: Professionals from Analytical Development/ QC/ QA/RA/ any relevant department

Duration: 2 months [Sunday batches, 5 hours per Sunday]

Course background: Appropriate analytical data review is a key requirement of Pharma industry. Warning letters, inspection observations talks majorly on gaps seen in internal review. Keeping this in mind, IPM is introducing a specialized course on ‘Analytical Data Review’ based on current regulatory guidelines.


  • Discussion on actual analytical data of API & Formulation
  • Various analytical tests- calculations and reporting results
  • Review raw data, HPLC/GC Chromatograms, excel sheets, COAs, protocols, reports


Section 1: QC: Responsibilities, Work flow, Pharmacopoeia, monographs

Section 2: Instrumentation techniques and use:

Tests, methodology, raw data reading, Interpretation, calculations & reporting

Review of :

Section 3: Analytical method validation & forced degradation study

  • FDS /AMV protocol, report
  • Linking of Solution stability and Robustness to test method
  • Common deficiencies

Section 4: Specification and COAs – RM, Excipients, APIs, PM, FP

  • Importance, Setting of tests, limits
  • Batch analysis & analytical exhibits

Section 5: Reference Standards and Working standards

Section 6: OOS, Incidences & Data Integrity

  • Challenges faced

Section 6: Stability data

  • Regulatory requirements of various countries
  • Protocol verses data, Stability specification
  • Acceptable data, unacceptable data

Section 7: Characterization

  • Techniques used- IR, UV, Elemental analysis & MS, reading & interpretation
  • Polymorphism by XRD, IR & DSC – reading , interpretation and conclusion