This workshop will be focused on addressing challenges faced by global, corporate & site professionals before and during a regulatory audit. The individuals will be exposed to the regulatory expectations & best practices for training, preparing, responding during hosting an Unannounced & announced audit?
The workshop modules would be encompassing the global regulatory expectations such as USFDA, EU, PIC/s, HC, Singapore HPA, PMDA Japan, ANVISA, GCC, MCC South Africa, WHO, TGA not limited to mentioned agencies.
Modules would be structured around the regulatory expectations & focused around USFDA & EU type of inspections, compliance Focus, Regulatory Inspection Management and Consequences of Non Compliance.
A key aspect of this recommendation is the mandatory requirement of unannounced audits for all manufacturers certified under one of the European medical device directives (AIMDD, MDD, IVDD) at least once in every third year.
The key discussion point would be as which audit can be performed Unannounced? The goal of the unannounced audits is to assure day-to-day compliance of the manufacturer’s product and quality management systems.
Udaykumar K. Rakibe
M.Pharm., Ph.D., MBA Founder, PharmaMantraTM
Udaykumar is a quality professional with a dynamic career steering organization through complex Quality & Regulatory challenges, transitions, building an empowered and talented workforce in the cross-cultural environment within highly competitive products and regulatory environment.In Year 2006, as Director – Quality Assurance, he was mandated and given the task to execute and spearhead the proactive remediation at Ranbaxy Lab. Ltd. Subsequently since Daichii Sankyo takeover, he was made Head, India and Asia Quality Operations and overseeing the state of control. In late 2011 he was recruited by Intas Pharma Ltd. to create a self-sustaining quality management system and enhance inspection readiness. Further, in 2013 he was hand-picked & recruited by Wockhardt Ltd., as Senior Vice President – Quality, to turn around the Quality Management, lead and manage the remediation of Quality initiatives. He has represented the Organisation as Quality Head and prepared, presented and attended the regulatory meetings with IAG/ MHRA/ IMB/ USFDA at London and Washington. Has performed 400+ Audits and faced 500+ regulatory audits.
He began his career in Quality function as an Executive In-process QA and then moved to different levels and organization spanning three decades of hands-on and hard-core experience in the pharmaceutical regulatory environment. He has gained the domain experience in Quality & Operations, specifically focusing and leading the Quality & Regulatory remediation in last 12 years (2006-2017). He has worked for a decade in Corporate Quality functions, overseeing the Project Management, Toxicological Assessment, Clinical, BA/ BE, API & DF Development & Dossier filing for developed markets and developing economies. Has setup the Global Quality organization for the Manufacturing Site (Multi-product manufacturing), Contact Manufacturing & Testing in regulated and semi-regulated markets.
He has founded the consulting firm, PharmaMantra, a Quality Advisory and consulting firm in August 2017. Since then he has performed Training, GAP assessment Audit, Site support during EDQM/ USFDA, Toxicological PDE Certification, and Consulting assignments for Indian and MNC clientele. He has proposed Corrective Action Plan and worked with senior management to maintain a culture of compliance and trust with regulators. He envisions thorough PharmaMantraTM, he shall be able to provide the Manufacturing and Quality Leaders the desired insights and advice to reach simple sustainable solutions for the seemingly complex situations/ problems/ activities. He has experience which can be shared and adopted for various stages of the Quality System developments and subsequent evolution to demonstrate the desired Culture of Pharmaceutical Quality.
Dr. Sanjit Singh Lamba
Managing Partner, Trillyum Consulting & Advisory
Vice President, (Corporate Quality Head), JB Pharma
Head Of Quality Assurance, Themis Medicare
Jayakumar A V
Executive Vice President - Corporate Quality at Ajanta Pharma Ltd
Omprakash S. Sadhwani
Former Joint Commissioner & Drugs Controller Food and Drug Administration, Maharashtra
Former Member of Drug Technical Advisory Board (DTAB)
Expert in detection and investigation of cases
Faculty on trainings in investigation skills
Wide expertise in policy making for state FDA
30 years expertise in enforcement of Drug Laws
Gaurav Puraskar by Govt. of Maharashtra – 2008
Best Drug Control Officer of India by All India Drug Control Officers’ Confederation – 2010
COO, Tiblo Consultancy Services, Mumbai
Director, Xplore Heathcare Solutions LLP, Thane
Founder, FDA Lytics
Founder and Director of Operations at Proexp Pharma Pvt. Ltd.
Sanjay Gade is a graduate and a post graduate chemical engineer from Institute of Chemical Technology (ICT)(formerly UDCT, Mumbai) with more than 36 years of diverse industrial experience in research and development, manufacturing and project management. He has worked in Pharmaceutical, Fine and Bulk Chemical Industries. He has successfully developed several novel technologies, improved many processes, designed, set up and commissioned world class, cGMP API and pharmaceutical manufacturing plants, scaled up more than 100 Active Pharmaceutical Ingredients, intermediates (~400 Nos.) and a few pharmaceutical drug products (10 Nos.). He has strong expertise in the areas of process development, technology development, process design, process engineering, process optimization, improvisation, process safety management, process hazard testing and analysis, particle engineering, polymorph development, scale up, technology transfer, trouble shooting, capacity de-bottlenecking, process intensification, project management, contract manufacturing, etc.
He has 15 patents and several technical papers to his credit. He is a senior member of American Institute of Chemical Engineers and a senior member of the Indian Institute of Chemical Engineers.
He is currently founder director of a startup company, Proexp Pharma Pvt. Ltd., engaged in contract chemical process research, custom synthesis and development, manufacturing, and marketing of pharmaceutical and agrochemical active ingredients and intermediates. The company is tied up with many associates for down and upstream value additions from concept to commercialization of API and Finished products.
SR. Vice -President, Corporate Quality, IPCA
Participants will be trained & exposed to the process, preparation, responses during hosting an Unannounced & announced audit?
How should you verify and authenticate the auditors when they show up on our premises for an unannounced audit?
Understand the entire unannounced audit process
What are the implications of the FDA Form 483 for agency enforcement and what happens next?
Who Should Attend?
Professionals from Drug Substance (DS)/API, DF(Drug Formulations), Devices, Biosimilar/Biotechnology engaged in research, scale-up, manufacturing, testing, regulatory, supply chain not limited to mentioned
R&D Professional ( Process, Analytical)
IT heads, Manager
- 6 Quality systems approach
- Quality Metrics
- Regulatory industry perspective ( Collation of the 10/5 yrs data, 483, warning letter & top 5 observations)
- Site Management –Role identification & introduction to inspector : Most responsible person, Host, facilitator, SME, Scribe, Runner, Reviewer, Archivist
- Training to the site inspection theme on hosting the regulatory audits
- Record the inspector request, avoid any delay/denial/refusal to produce requested documents
- Management Back room/war room, documenting the list of requested documents & meeting the request in 5-10 min, If SME is off-site ask for time from inspector.
- Communicate to resolve any issues due to documentation & misunderstanding
- Day end briefing with inspectors and give clarification
- Daily review of documents seen by inspectors & observations made
- Daily site meeting reviewing the day.
What does it mean if you receive Form 483 from an FDA INVESTIGATOR?
- How do I avoid Form 483?
- What happens if you fail an FDA audit?
- What major reasons do companies get 483 letters from the FDA
- Case Studies
- Inspector reads-out the summary observations / 483
- Site an opportunity to give a clarification once again
- Corrections in the 483 maybe done by inspector & reissue the 483
- Compliance & the response to 483 shall be done in 15 working days
- Other regulatory such as EU/MHRA may do a read-out and detailed report will follow in fortnight
- The 483 / Corrected 483 shall be issued on conclusion at site, the compliance response to each 483 shall be done in 15 working days, acceptance of response will lead to release of EIR
- Other regulatory such as EU/MHRA may do a read-out, the detailed report shall be sent by the GMP inspector in about 15 days, the response to 483 shall be done in 15 working days, opportunity is to coordinate with the QP of the release site, acceptance of response will lead to Issue of CGMP certificate
- Non acceptance leads to agency action such as warning letters, import alert, suspension of CGMP license
Recap of Day 1
Presentation - Remediation activities
- How do you respond to a written warning?
- Are 483 letters public?
- How long do you have to respond to a FDA warning letter
- What are the implications for when a site receives a Form FDA 483?
- Remediation action in case of warning letter, import alert as CAP( corrective action Plan)
- In Remedial activities 3rd parties are recommended to independently review the CAP & give substantial evidence of compliance to the regulatory & Quality systems
Data Integrity – An understanding of Ethics
- Various categories of Data Integrity Issues faced by the Industry
- Relevant Global Guidelines
- The Way Forward – Investigations, Root Cause Analysis , CAPA , SOPs , Training
- Learnings from Customer Complaint and Audit/Inspection observations
- Learnings from Regulatory Authorities reviews of Dossiers and Facilities – Pertaining to Development, Technology Transfer , commercialization and Regulatory Submissions.
- Case Studies- Real life examples from across the globe
Another key focus in today's FDA audits
- Risk Management – Assessment /Mitigation – Built in from the very beginning
- The Basics as per the Guidelines revisited- Current Requirements
- Building in right through Development, Scale-up & Technology transfer
- The Precursors for Risk Assessment- Deviation Management- Reporting, Investigating
- Manufacturing Process and Analytical Methods
- Learnings from Customer Complaint/ Non conformances; Audit/Inspection observations
- Learnings from Deficiencies from Regulatory Authorities - Dossiers and Facilities
- OOT and OOS Aspects
What are the 7 steps in audit process
- what are the 3 main types of audits
- What is the difference between an unannounced audit and a random audit?
- Conducting internal audits
- GMPs and FDA inspections