Mohan Reddy Badala

1. Change Control Management. 2. Deviation & CAPA. 3. QbD Application. 4. Quality Risk Assessment. 5. Self-inspection/ internal audit. 6. Training Management. 7. SOP preparation, review, revision and implementation. 8. Document issuance, maintenance & control. 9. GDP & cGMP. 10. Master Formula Card, Batch Manufacturing Records, Scale up, Process Validation, Hold Time Study, Stability, Compatibility Study Protocols and Reports. 11. Review of PDR and CTD quality module 3.2.P.2.

1. Change Control Management. 2. Deviationand CAPA. 3. QbD Application. 4. Quality Risk Assessment. 5. internal audit. 6. Training Management. 7. SOP preparation, review, revision and implementation. 8. Document issuance, maintenance & control. 9. GDP cGMP.

1. MFC, BMR, Scale Up Batch & Process Validation Protocols and Reports, Stability Study Protocols & Reports. 2. Tech transfer & Process Validation Batch Execution. 3. Review of analytical results. 4. Tech transfer and Process Validation Report Preparation. 5. Product Development Report. 6. Intended Commercial Batch Manufacturing Record. 5. Review and revision of plant manufacturing documents and protocols as a part of technology transfer and regulatory submission

Planning and execution of R&D batches. Sampling and submission of samples to QC. SOP preparation, MFC preparation and calibration of R&D instruments. Entering of data in LNB and log books. Routine monitoring of stability chambers. Loading and withdrawal of stability samples. Co-ordination with manager for R&D batches execution strategy and compilation of reports.

MODERN PHARMACEUTICAL ANALYSIS, PREFORMULATION AND PRODUCTION MANAGEMENT, BIOPHARMACEUTICS AND PHARMACOKINETICS and ADVANCES IN DRUG DELIVERY SYSTEMS.

Pharmaceutical Organic & Inorganic Chemistry, Anatomy, physiology & Health Education, Biochemistry, Pharmaceutical Technology, Pharmacy Practice, Physical Pharmaceutics, Pharmaceutical analysis, Advanced Medicinal Chemistry, Pharmacology, Pharmaceutical Dosage Forms, Pharmaceutical Biotechnology.