Why Should You Attend
This important seminar will cover an overview, as well as practical case studies with examples faced by Pharma industry today, while facing highest regulatory requirements and expectations from US, Europe, and other regulatory authorities.
The speakers have between them 65 years of total experience between them and exposure to all above investigators and audits. This seminar is especially valuable to not only those within the Quality area of your Company, but also within other Departments to include Incoming Raw Materials, Manufacturing and Facilities. Because of the sensitivity and importance of understanding Quality Metrics, this seminar is a MUST for anyone in your organization that is involved in the management of, or recipients of Regulatory actions.
More than 60% inspection reports such as 483’s and Warning Letters quote Data Integrity as deviations from GxP regulations. If you receive a Warning Letter, you may have to stop operations, train all of your employees, validate your processes, validate your testing methods and re-qualify your records. You will also be required to hire consultants. This will cost you millions of dollars and could take several years to re-start your operations.
Those who don’t have exposure, those who have some but not enough exposure to such audits should attend this seminar to gain knowledge and take to work good practices. Also, it is a trend for the FDA to perform both GxP and Part 11 inspections, with an updated Annex 11 regulation that expands Part 11 requirements, and companies must update their systems and processes to maintain compliance.
You must attend this conference because you will learn how to insure that your facilities will continue to use processes that are under control, and will consistently deliver quality products. This training course will contain an intermediate review of these FDA quality procedures and explain why it makes business sense to follow these laws.
Also, the lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters. Most companies have procedures but either they are not adequate or are not followed. This seminar will guide attendees through the entire process from detection an out-of-specification result to informal and formal laboratory and batch investigations.
Interactive or question and answer sessions at the end of each session will add great practical value to your experience.
A must attend seminar for professionals in:
√ Pharmaceutical Development Companies
√ Quality Control Laboratories Companies
√ Quality Departments of API Manufacturers
√ Quality Departments of Finished Product Manufacturers
√ Contract Laboratories
√ Clinical Research Organisations
The teams that will benefit the most are:
√ Quality Control & Quality Assurance
√ GxP and Regulatory Compliance
√ Analytical Research and Development
√ Corporate Quality
√ Research and Development
√ Laboratory Quality Department
√ Developmental Quality Assurance
√ Contract Testing Laboratory
√ Regulatory Affairs
√ Product Failure Investigators
√ Training Departments
√ Documentation Departments
Professionals who will benefit include:
√ Managers and Supervisors
√ Senior Managers and Team Leaders
√ Analytical Research Specialists
√ Validation Specialists
√ Laboratory Managers and Supervisors
√ Regulatory Affairs Managers
√ Documentation Specialists
√ Internal, External and Third Party Vendor Auditors
1. Dr. R. Rajendra Vidwans, has been effectively using 38 years’ experience in Pharma operations including production, projects, Quality. Now working independently in GMP audits, inspections, training, GMP consultations, Quality systems, Risk assessments etc..
Since 1976 he’s worked with numerous Pharmaceutical companies. He was President Manufacturing at a Pune based Pharma manufacturing and marketing company. He was working as a Director (equivalent to Sr. Vice president) in a Pune based Asia’s largest and world’s third largest privately owned, vaccine-producing company; Serum Institute of India Ltd. Last 4 years, specialized consultancy in GMP,QMS, trouble shooting in operations, valuable suggestions in production, regulatory approvals, due diligence etc.
2. Mr. B.H.K. Reddy, is Master of Science in Pharmaceutical Chemistry from BITS Pilani. A dedicated Professional with vast cross functional experience in Highly Regulated Quality Control Laboratory Operations, Analytical Quality Assurance, Analytical Method Validations, Stability Studies and Data Integrity Compliance in the Pharmaceutical and Biotech Industries.
He has worked as QC Laboratory Head positions at Dr.Reddy’s Labs, Micro labs, Wockhardt Ltd and Cipla Limited. He has immense knowledge in implementation of Data Integrity Compliance Systems, Electronic Records, Electronic Signatures (21 CFR Part 11) in Quality control/Analytical Testing Labs.
He is a Qualified Third party Auditor in detecting data integrity problems and assist them with into compliance with cGMP regulations. Performing Training to various pharma companies on: Laboratory Data Integrity Investigations and Compliance, Computerized Systems Validations, Part 11 Compliance. Assessment and Evaluation of Computer System validation (Part 211) and E-Record Integrity (Part 11).Conduct Mock Inspections of GxP Quality Systems, Laboratory Compliance, Data Integrity and part 11 compliance with Development and Implementation of Data Integrity compliance SOPs.
He guides companies by performing the OOS/OOT/Analytical Incidents Investigations and monitoring of CAPA. He assists in preparation of response to various regulatory Audit findings. Working knowledge of QC Software’s validation to ensure data integrity and Audit Trail Monitoring as per 21 CFR part 11 & EU GMP Annexure 11 (computerized systems) for XRD,UV-Vis Spectrophotometer, HPLC, G.C, FTIR, Liquid Particle Counter, Malvern Particle Sizer, Auto Titrator. etc. He has proven abilities in successfully facing the various regulatory Audits and setting up new testing Laboratory to meet USFDA/UKMHRA/WHO/TGA guidelines. He has assisted numerous companies for setting up of Quality Control Systems and Laboratory Data Integrity Assurance System and successfully completed USFDA Audit with zero 483s. He has conducted workshop on GLP, Data Integrity, CSV, Part 11, Management of Laboratory data Management.
Mr. Reddy and Dr. Vidwans have joined hands with Compliance Trainings as Expert Trainers and Consultants with a common mission to share knowledge and empower the Indian Life Sciences Industry.
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM (Welcome and Introduction)
- Data Integrity:
√ Data Integrity and Pre-Requisites
√ Data Integrity in QC and Non-QC Laboratories
√ Data Integrity Life Cycle Approach
√ Causes, Where & How to know the occurance
√ Regulatory Expectations for Data Integrity
√ Requirements to meet Data Integrity
√ Real Examples of Data Integrity Issues
- cGMP Regulations and Guidance Related to Data Integrity:
√ 21 CFR Part 11 Requirements
√ Practical implementation with case studies.
√ EU Annexure 11 Requirements and implementation guidance.
√ MHRA/USFDA/WHO/PIC’s data integrity Guidelines Interpretation with case studies
- Warning Letters:
√ Data Integrity Related FDA 483s and warning letters
√ Major Sources of Data Integrity and Criteria to Assure Data Integrity
√ Data Integrity Audit Methodologies
- Quality Metrics:
√ Quality Metrics Background
√ Process Validation and Quality Metrics
√ The Use of Quality Metrics
√ Effects of Non-Reporting
√ Reporting of Quality Metrics
√ Review of Pertinent Form FDA 483s and Warning Letters
- Q&A Session
Networking and Close: 5.30 PM – 6 PM
Session Start Time: 9:00 AM
- Good Documentation Practices:
√ Principles of Good Documentation Practices
√ Good Standard Operating Procedures (SOPs)
√ Good Batch Manufacturing Record (BMRs)
√ Good Log Books
√ Mistakes made in each of the above
- Out of Specification Investigations in cGMP Regulatory environment:
√ Laboratory OOS
√ What is an OOS result and Need of OOS investigation?
√ OOS Data management as per Regulatory Requirements
√ Interpretation of Investigation Results and Reporting
√ Documentation of OOS results
√ Recent Regulatory Citations on OOS
√ 2 OOS Results Investigation Case Studies
- QMS and Incident Management in cGLP environment:
√ Why cGLP required?
√ GLP Requirements as per FDA 21 CFR Part 210 and 211.
√ Common Incidents in the laboratory
√ How to handle and Minimize Laboratory Incidents
√ How to close the Laboratory Incidents
√ Processing Mapping Techniques in cGMP Compliance to avoid data Integrity issues.
- FDA Inspections:
√ Guidance for Industry
√ Using these valuable guidance documents to prepare for audits
√ Other best practices to prepare for and face Regulatory (FDA, EU, etc..) Inspections
- Final Q&A Session
Certification, Networking and Close: 6 PM – 6.30 PM
Please ensure to arrive at the venue between 8.30 AM and 9 AM on the first day.
Schedule includes (on both days):
√ Start Time: 9 AM
√ Training sessions
√ Morning Tea Break
√ Lunch Break
√ Afternoon Tea Break
√ Q&A Session
√ Networking Session
√ Closing Time: 6 PM
For any queries regarding the schedule, please feel free to contact our Support Team.
√ Chalk and Talk
√ Group Discussion
√ Case Studies