Specific Requirements for Manufacture of Biological Products Schedule M, Part IV
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The objective of the Webinar is to provide the details about “Specific Requirements for Manufacture of Biological Products, Schedule M, Part IV” a new chapter, that can be applied to the manufacture, control, and testing of biological products for human use from starting materials and preparations (including seed lots, cell banks, and intermediates) to the finished product within the life sciences industry. The principles and general considerations are based on a control strategy across all stages of manufacture with the application of risk management based on life cycle approach to reduce contamination and cross-contamination.
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
About the Speaker:
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.
■ 5 Yrs Warranty ■ 15+ Monopoly Specs. ■ Online Hygrometer ■ Validation & Online Data Logger with BLUETOOTH/WI-FI/ETHERNET/RS485/GSM-GPRS ■ Lab Monitor & Master Instr. ■ Sensor & TX ([email protected] ■ +91-9398693085)
1 个月Nice Post
Lead Qualification& Validation and shopfloor quality
10 个月Nice presentation sir, thank you for covering all aspects of biological products and sharing your insights. Really it is very informative and useful. Look forward to hear more webinars from you... Thank you once again
Quality Assurance @Bharat biotech X-Casper pharma X -Cronus pharma X-Vins biopharma X- Sanofi ,X- Vivimed
10 个月Informative sir
Manufacturing vaccine at Serum institute of india pvt.ltd
10 个月Please confirm the date time and venue for webinar
Quality Assurance Manager at CuraTeQ Biologics with expertise in Quality Management
10 个月Excellent session sir, informative expecting more sessions like this from you.