The Webinar will provide the details about New and Critical Requirements for Manufacture of Biological Products, for the manufacture, control, and testing of biological products. The webinar will discuss the following topics broadly.
1. The manufacture, control, and testing of biological products for human use from starting materials and preparations to the finished product.
2. Pharmaceutical Quality System and Risk Management
3. Seed Management (Seed lots/Cell Banks)
4. Personnel, Material, Premises and Equipment
5. Containment and Biosafety Risk Levels
6. Cleanroom classifications
7. Biological products Production and Batch processing Records
8. Biological Process Validations
9. Quality Control Testing for Biological products
10. Handling Market Complaints and Product Recall
Nagarjuna AKULA, Ph.D has 30+ years of extensive experience in the Pharmaceutical and Biopharmaceutical industry. He is highly expertise in Quality and Regulatory Affairs, Project Management, and Technology transfers, and exposed to Sterile Injectables, Human Vaccines, Oral dosage, and Active Pharmaceutical Ingredients manufacturing. He played senior leadership roles in global companies like Sanofi and Dr.Reddy`s Laboratories and handled several successful regulatory inspections. Presently working as President, Quality Operations and Regulatory Affairs at Bharat Biotech International Limited.