Eminence Business Media’s debut edition of “Improving Investigation Process & CAPA 2018” successfully concluded on October 11th & 12th, 2018, at Hotel Sahara Star, Mumbai.
Eminence Business Media’s debut edition of “Improving Investigation Process & CAPA 2018” was an outstanding success with over 90+ delegates attending the workshop with Sparta Systems, Double Dragon Consulting & Pharma Mantra partnering the event.
The two-day workshop ensured the continuous engagement of the audience, speakers & exhibitors though networking activities & discussions with regards to the ever-evolving challenges of the pharmaceutical industry pertaining to improper investigation process & CAPA and how to avoid the warning letters due to the non-compliance of CAPA.
The workshop saw as many as 15+ sessions, a panel discussion & a special musical rejuvenating activity over the two days, attended by the CEO’s, MD’s, Heads of Quality Assurance/Quality Control, Engineering, Production & Regulatory managers of the pharmaceutical& biopharmaceutical manufacturing companies.
The event was inaugurated with the opening remarks by the workshop leader & chairperson Dr. George Bernstein, Principal Double Dragon Consulting Inc. in the presence of various eminent personalities from the Indian Pharmaceutical Industry. Dr. Bernstein agreed that the number of USFDA inspections has dropped drastically in India as they have shifted their focus to China & more recently towards South America. He also added that since August 2018, there were 7 warning letters issued to Indian Pharma Companies and 57% out of those which is more than half, had an observation related to investigations not being acceptable and inadequate. In 2017, there were 14 warning letters issued to the Indian Pharma Companies and almost half of them had an observation about Investigation being inadequate. He also mentioned, when he found the statistics of warning letters issued globally, he was shocked to see such a high percentage, and all had the same observation – inadequate Investigation.
“Investigations are a reflection of the company’s culture & its organizational maturity”
“He accepted that not only in India, even in countries like China, US the percentage is quite the same because the people who are put into Investigations are in-experienced – rather they are the new guys. Investigators don’t add to the bottom line of the company; thus, we do not hire too many of them. The new guys on the other side are unable to write technical documents clearly, plus they have a lot of pressure to close the investigations quickly. Now a days, people can write a 140-character tweet easily, but for them it is very difficult to write a technical document.
“Investigators are not Born, they have to be Trained”
In many companies the investigations are performed by the Junior staff and approved by junior QA staff which is indeed a big issue in today’s industry. Dr. Bernstein also raised an question to the audience asking, “If a person in Manufacturing department does something silly and created some deviation and some problem, so who is responsible for doing the investigation and figuring it all out? Is it somebody from the Manufacturing department or somebody from QA department who has absolutely no idea what’s going on!” The management today needs to make CAPA & Root Cause Investigation a priority, which is a rare scenario in today’s industry.
Dr. Bernstein shared his expertise on Regulatory Expectations & industry perspective on investigation process & CAPA with respect to Quality Risk Management – Health authority audit process & focus on investigations, what is quality risk management & high/medium/low risk definitions & mitigation actions. He also explained on the types of investigations – Deviation, Complaint, LIR, OOS & OOT. Dr. Bernstein shared some amazing examples in Introduction to Investigation Methodology & Documentation & the examples included – Hydraulic Fluid & the Titanic. He also explained – The traits of a good investigator & Anatomy of an investigation. He focused on RCA Methodologies with respect to the 5 whys, 7M’s, Fishbone (Ishikawa Diagram) & FMEA.
Day one of the workshop also comprised of a Case Study by Dr. George Bernstein on The Investigation Process with respect to Data Integrity & Manufacturing. Dr. Udaykumar Rakibe, Founder Pharma Mantra Consulting shared his experience on How to Identify Root Cause & Most Probable Root Cause including the definitions & purpose of RCA, Clarifying the goals & process of RCA, Developing the possible causes & determining & confirming the true cause(s).
Day 2 of the workshop kickstarted with the opening remarks by Dr. George Bernstein. He also shared his views on Importance of CAPA Methodology and explained the definitions of Correction, Corrective Action & Preventive Action. To explain this, he shared the examples of Hydraulic Fluid incident, Titanic incident, Lab Incidents, Chilled water leak, Column failure, System suitability failure & Metrology “as found / as left” OOT.
Dr. Bernstein explained about Tracking, Trending & Recurrence and how to maintain an effective CAPA program, what are the tools to be used & what metrics to report, how to report & whom to report them to. He also explained Statistical Tools & Data Analysis, Audits, Auditors, 483 & warning letter responses before giving the closing remarks of the workshop.
Day 2 also included presentations by Mr. Pankaj Kumar Singh, Alkem Labs on Global Implementation of CAPA and by Dr. Varada Bapat, AVP – Wockhardt on Non-Compliance of CAPA leading to 483’s. The day also witnessed a panel discussion on “Should culture change be a part of our remediation plans?” with panel discussion members including Dr. Ranjit Barshikar, Member of the editorial board – journal of generic medicines – England & QbD Consultant; Dr. Udaykumar Rakibe, Former Sr. VP, Wockhardt & Founder Pharma Mantra Consulting; Dr. Varada Bapat, AVP Wockhardt; Mr. Manmeet Singh, Head IT Quality Systems, Sunpharma; Mr. Vikram Pundir, Site Quality Head, Novartis and Dr. George Bernstein being the Panel Moderator.
A special musical rejuvenating activity was also organized for the delegates attending the workshop.