PHARMA 4.0 - Needs & Challenges With Respect To cGMP Compliance

21st - 22nd January 2019 Mumbai & 24th - 25th January 2019 Chandigarh

Course Description

Introduction to PHARMA 4.0 - Needs & Challenges With Respect To cGMP Compliance

In the past decade, there are huge technological advances, resulted in a new industrial revolution often referred to as the fourth industrial revolution or “Industry 4.0.” It’s a revolution driven by the exponential growth of disruptive technologies and the changes those technologies are bringing to the workplace, the workforce, in the markets organizations. “Pharma 4.0” is a term that references the future of quality and organizational excellence within the context of Industry 4.0. Pharmaceutical professionals can play a vital role in leading their organizations to apply proven quality disciplines to new, digital and disruptive technologies. Here’s your chance to ask an expert on this emerging topic!

Course objective/ Outcomes/ Benefits of the attending:
• In this session, you will learn the easy way to describe Pharma 4.0, how it can add value beyond IIoT (Industrial Internet of Things). Manufacturing and help us to identify new ways to solve old problems.
• How to generate Pharma 4.0 strategy for your organization based on digital transformation.
• This session will help pharmaceutical professionals a better insight on all processes for better decision making
 
Target Audience:
Management Personnel/ Directors/ Managers / staff / Decision makers from Manufacturing, QC/ QA/ Engineering, regulatory affairs, Contract Manufacturing Organization, Regulatory and compliance professionals, Personnel from data integrity team/ Audit and compliance team Quality professional – CQA/ DQA/ Regional QA/ Global QA All those who are or planning to engage in the export of pharmaceutical product to regulated markets and achieve highest cGMP Compliance.

For Delegates Registrations:

For Registrations Contact us on +91-9619046105 or email us on info@marcepinc.com

Training Agenda

Training Agenda For PHARMA 4.0 - Needs & Challenges With Respect To cGMP Compliance

Day-One

Section 1: Introduction and overview of the course -Objective/s and purpose of pharma 4.0, 
Evolution of pharma 1.0 to 4.0
Section 2: Relation of subject with ICH guides. Current FDA expectations of pharmaceutical Quality Systems.
Section 3: Reactive Vs proactive approach - Moving frommonitoring of Variability of process control to controlling the variability in pharmaceutical environment/Instruments
Current ways/controls of monitoring variability
Involvement of ISPE in supporting pharma 4.0
Tea Break
Section 4: Role of pharma 4.0 in quality improvement
The risk behind not following the NEED
Operating model of pharma 4.0
How the model look like
Section 5: Moving from R&D to Manufacturing and from manufacturing to patient 
The importance of e-concept, 
Lunch Break
Section 6: The more focus onData Integrity
Basic requirements about Data Integrity
Importance of control (Process/Technical) on Data integrity evaluation.
Section 7: Auditing for Data integrity Aspects – Guidance requirements, Evaluate the data backup and archival practices, Types of data fraud, organization culture and Integrity, Tips to identify the data integrity issues
Difference in current data integrity requirement with respect to future need.
Tea Break
Section 8: The involvement of some electronic or automation industries with pharma 4.0
Section 9: Practical session on current automated controls over traditional manual controls.
Summary of Day 1. Q&A
 
Day-Two

First day fast forward
Section 10: Digitalization in pharmaceuticals, scope of cloud technologies, 
Section 11: Impact of pharma 4.0 on Quality Control Unit
Section 12: Implications of Pharma 4.0 -
Pharma sector will need to go beyond compliance
R&D need to go beyond lab
The pharma and healthcare value chain will be become much more intervened.
Tea Break
Section 13: Challenges with the new concept.
Cost
Integration with the market need
Automation
Validation, Manpower….so on
Lunch Break
Section 14: Some practical insight with respect to pharma 4.0.
The examples where companies started working/development of tools towards pharma 4.0
Tea Break
Section 15: Sharing of References, Concept papers
Summary of Day 2.
Q&A, Feedback form
Certification
Vote of Thanks
 

For Registrations Contact us on +91-9619046105 or email us on info@marcepinc.com

Course Director

A Quality oriented professional with over 2 decades of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance. The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines. The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc. Independently handled - Quality assurance and Quality Control department for more than 13 years. Audits faced- USFDA (5 times), ANVISA, MHRA, MCC, TGA, IDMA excellence, WHO audit, EU regulatory (5 times), Yemen MOH, Digemid (Peru), Russian Authority audit etc. Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments – HPLC, GC, IR, UV, Visible spectrophotometer, AAS etc. Major GMP software used- Lab solution software, Empower 3 software, LIMS, TRIMS & Track wise. During tenure audited more than 500 vendors/suppliers and trained more than 2000 candidates. Member of American Society for Quality & Indian Pharmaceutical Association.
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