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    • Schedule M webinars
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  • Webinar Registration
  • Schedule M webinars
  • Science behind Schedule M
  • Recorded Webinars
  • Recorded Webinars
  • Recorded Webinars
  • Recorded Webinars
  • Recorded Webinars
  • Recorded Webinars

Critical Requirements for Manufacture of Biologocal Products

Nagarjuna AKULA, Ph.D

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.  

Understanding C S V as per revised Schedule M

Sharmila Valleru

In this webinar  following will be discussed

1.⁠ ⁠Scope and Purpose of validation

 2.⁠ ⁠Computerized system validation protocols and reports

 3.⁠ ⁠Supplier management

 4.⁠ ⁠Requirements specifications

 5.⁠ ⁠System design and configuration specifications

 6.⁠ ⁠Design qualification

 7.⁠ ⁠System development and project implementation

 8.⁠ ⁠Installation qualification

 9.⁠ ⁠Operational qualification

10.⁠ ⁠Standard operating procedures and training




Revised Schedule M: Practical approach to implement Q R M

Mr. B. Sankar

In this webinar  following will be discussed

  1. Basics of Quality Risk Management Process
  2. Introduction to principles of Quality Risk Management
  3. General overview of QRM Process
  4. Introduction to Risk Management Methodology
  5. Practical challenges in managing QRM process.
  6. Knowledge and Change Management
  7. QRM – Going Digital


Qualification of Analytical Instruments - Schedule M

Dr. Bob McDowall

This presentation will deal with Qualification of Analytical Instruments as per Schedule M , WHO , USP and EU requirements.  


Schedule M : P W. Sysgtem Qualification & Compliance

Dr. Nissan Cohen 

With the recent notification of Revised Schedule M by CDSCO, ensuring product quality and compliance has become more critical than ever. To help you navigate these changes, ISPE India Foundation is proud to present a webinar on “ P. W. Systems compliance to India , US , EU Pharmacopeia using QRM & PAT 


Revised Schedule M Part : Requirements for Oral Solids

Vipul Doshi 

With the recent notification of Revised Schedule M by CDSCO, ensuring product quality and compliance has become more critical than ever. To help you navigate these changes, We are  proud to present this webinar covering key aspects of requirements for OSD.  


Revised Schedule M Part : Qualification & Validation

Sundar Chellaman

The Webinar will provide the objective and scope to detail the basic principles of qualification and validation, that can be applied to equipment, utilities, facilities and software within the life sciences industry. 


REVISED SCHEDULE M PART II: STERILE PRODUCTS COMPLIANCE

Vipul Doshi 

With the recent notification of Revised Schedule M by CDSCO, ensuring product quality and compliance has become more critical than ever. To help you navigate these changes, We are  proud to present this webinar covering key aspects of Part II. 


The information collected when you register for a webinar will not be shared with any organization and will not be used for any commercial purposes. We follow the provisions of Indian Information Technology Act  to protect your data. 

pbpwindia@gmail.com

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