16th - 17th May 2019 Mumbai

Course Description

Course Background for Pharmaceutical Faclity Inspections

Pharmaceutical Quality Management Systems in the industry are lacking Effective monitoring and controls as evident from the increasingly high numbers of Repetitive non-compliance reports being issued by the FDA & Other Regulatory Agencies
Any Quality Process or system needs to be under constant observation for appropriate checks and alert/alarm systems to ensure proper controls.
The Quality systems and procedures need to be unbiased to ensure quality assurance of the pharmaceutical products reaching the end user. This has been identified as a critical and ongoing problem by Regulatory Agencies and is pretty much evident from the recent 483s, Warning letters and Import alerts issued by these agencies to Pharmaceutical organizations worldwide.
Awareness regarding all relevant guidances implementing the critical aspects relevant to an organization's product grid via the right written down procedures and managing the transition phase are instrumental in carving out the right pathway to bridge these gaps .

Take-aways from the Workshop:

At the end of this workshop the cross functional team members will not only be more conversant with the current gaps in their organizations regarding Quality Management Systems but will also learn effective methods and the way forward to bridge them and align themselves with the current global Regulatory & GMP Expectations. By channelizing the Management for effective monitoring to control systems and processes, the organizations would be able to manage the risks involved via timely decisions to achieve the business aspirations. This in turn would
result in faster approvals of Marketing Authorization applications which includes GMP Compliant Manufacturing facilities thereby meeting the business aspirations of the Company.
For Regsitration: Cell: +91-9619046105 Email: -

Training Agenda

2 Day Training Agenda for Pharmaceutical Facility Inspections


Introduction and Background
Module 1 - Pharmaceutical Facility Inspections-
Nightmares or Eye Openers with regard to GMPs
• Types of Inspections
• Recent and Repetitive GMP Issues in Pharmaceutical Industries worldwide
• What is inevitable as of 2018-based on the increasing no. of 483s and Warning Letters
• Responsibilities of the Management and Quality Control Units
• Major Areas of Concern as per FDA – How do Industries deal with these
• Key Guidances, Directives and References
Module 2 - The EMA viewpoints on Quality Systems
• The EU expectations regarding Quality Oversight
• Relevant and Repetitive observations during inspections
• How to synchronize the FDA and EU thought processes
• Customer base Implications
Activity - Interactive / brainstorming session 1
Amongst the Participants regarding practical issues being witnessed wrt existing Pharmaceutical Quality Systems in
their organizations as per above modules during development and commercialization vis-a-vis Global
Regulatory requirements.
Exemplary/ Prospective solutions based on real life case studies to minimize/avoid Inspectional Observations by Key Regulatory Authorities.
The Do’s and Don’ts of Inspections
Module 3 - Quality Management Systems-Designing, Reviewing, Implementation and Upgradation
• Risk Management and Quality by Design criticalities
• Good Documentation Practices- Internal/ External
• Good Communication Practices- Internal/ External
• How to handle the transition phase while migrating to a more effective and dynamic Quality Management & Oversight System
• Multiple Manufacturing sites- the linking
• Outsourcing Activities
Module 4 - Change Management and Regularization
• Major Issue leading to Inspectional Observations
• Key Elements - Category, Approval, Implementation & Regularization
• Root Cause Analysis, Corrective and Preventive Actions
• Risk Management and Quality by design elements- Customized as per the kind of Change being Implemented
• Handling Multiple Products, Multiple Customers, Multiple Markets & Diverse Regulatory Filing Strategies
Activity- Interactive/ brainstorming session 2
Amongst the Participants regarding measures being taken for handling multiple CMOs/ CROs
Designing the Appropriate and Adequate SOPs
Executing the right Purchase and Quality/ Technical Agreements with vendors
Conclusion Day 1-Take-aways for Implementation and Quiz!
• Control and Alert Points – Detecting issues early enough to be able to rectify
• Cross Functional Team Time Management
• Review, Revise and Implement the right SOPs
• Integrity- People as well as Data

Brief Recap of Day 1
Module 5 - Diverse Quality cultures – Across Organizations and the Globe :
• The Challenges and Issues -Quality Oversight Management
• Evaluation system of Outsourced Activities
• Vendor Development and Qualification
• Implications- Warning letters, Statements of Noncompliance, Import Alerts, Consent decrees and Delay in Approvals of Marketing Applications
Module 6 - Avoiding Occurrence and Repetition of cGMP Violations
• Designing, Maintaining, Monitoring and Implementing the right SOPs- Continuous evolution in terms of Guidance and Inspectional Observations
• Learning from Customer Complaint and Audits
• Learning from Deficiencies from Regulatory Authorities in terms of Dossiers and Facilities
• Incorporation of QbD & Risk Management elements right from Development stages through Technology Transfer, Scale Up and Commercialization
Activity - Interactive/ brainstorming session 3
Out of Trend and Out of Specification Results Measures being taken for building in Quality in pharmaceuticals wrt Manufacturing and Stability
Studies during development and commercialization
Module 7 - Learning from Case Studies and Real life examples
• The relevance of Turn around time to address Queries and deficiencies regarding Quality Issues – Far Reaching Impacts
• Project Management
• Management Support [Quality Oversight]
Module 8 - Trends and Reasons for Repetitive
Non- Compliance of Manufacturing Facilities
• For Active Pharmaceutical Ingredient
• For Finished Dosage Forms
• For Contract Research, Contract Manufacturing and other Outsourced Facilities
Module 9 - Timely, Adequate and Accurate Responses - A combination of Technical as well as Soft Skills
• Acceptance of Flaws and Commitment for Remedial actions in a timely manner
• All supporting Analytical Data to be shared with the responses
• Lessons and Learning- Devise Corrective and Preventive Actions
Conclusion Day 2 - Take-aways for
Implementation and Results of the Quiz!
• Integrating the key cGMP practices via SOPs and ensuring Successful Implementation
• Documenting everything adequately and accurately
• Accepting the Gaps and Rectifying them to ensure Compliance
• Design and implementation of best practice quality improvement programs via on the Job, Classroom and External Training and Mentoring
For Regsitration: Cell: +91-9619046105 Email:

Course Director

Ms. Rajni Jha - A senior experienced Pharmaceutical Regulatory Affairs and Quality professional, with 3 decades of Pharmaceutical industry experience. This includes working in key Departments viz., Chemical Research Division, Corporate Regulatory Affairs, Development Quality Assurance and Corporate Quality Assurance to support the Techno commercial and Project Management teams to ensure meeting the business aspirations of different Organizations. Her academic Qualifications include Post Graduate Research work [as a part of Ph.D Program] at I.I.T Kanpur, India in addition to a First Class Masters Degree in Synthetic organic Chemistry. Through her versatile career, she had worked with leading Indian pharmaceutical organizations such as Ranbaxy Research Laboratories, Torrent Pharmaceuticals Limited, Glenmark Generics Limited, Unimark Remedies Limited, Nicholas Piramal, Indswift Laboratories Limited to name a few. The areas of her diverse experience and expertise lie in API Research including Technology transfer and Scale-up activities, International Regulatory Affairs, Compliance, Corporate Quality Assurance and Regulatory as well as Customer Audits and Inspections. A few highlights during her career include the successful submission of Various DMFs and CEPs instrumental for Obtaining Marketing Authorizations [Via multiple Regulatory Procedures] globally for key Customers for Formulations in various therapeutic segments; maintenance of existing DMFs & CEPs with current regulatory expectations; development and up-gradation of various Protocols/ Checklists/ SOPs for CQA [Corporate Quality Assurance] and RA [Regulatory Affairs] for several global Audits for different products via multiple marketing Procedures in line with ever changing Regulatory Scenario globally-viz., USA, Europe, Australia, Latin America, Asia Pacific, Japan, Korea, Russia, and other countries .
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