Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.
This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.
Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.
• Learn about the regulatory background and GMP requirements for quality control and contract laboratories.
• Understand and be able to explain your company's quality plan or laboratory compliance master plan.
• Understand the difference between GMP and non-GMP laboratories.
• Learn how to develop inspection ready documentation.
• Be able to train others in your organization on GMP requirements.
• Learn how to avoid and/or respond to the FDA inspectional observations and warning letters.
For easy implementation, attendees will receive free access to "Laboratory Compliance Package" as Web download.
This package includes 46 SOPs, a compliance master plan, checklist and templates that help to implement GMP requirements in laboratories
• 50-Page primer: FDA GMP Compliance in Analytical Laboratories
• Laboratory Compliance Master Plan
• Worksheet - Laboratory Audits
• Following Standard Operating Procedures:
Who Should Attend:
This seminar will be beneficial to the following personnel in FDA regulated laboratories:
• Analysts and lab managers
• QA managers and personnel
• Validation specialists
• Regulatory affairs
• IT professionals
• Human resources (HR) managers and staff
• Training departments
• Documentation department
• Consultants& teachers
Dr. Ludwig Huber
Chief Advisor - Global FDA compliance, Agilent Technologies
• Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
• Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
• Presenter of the Year of the Institute for Validation and Technology
• Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories.
• Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"
Location: Mumbai, India Date: January 23rd and 24th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The Leela Mumbai
Address: Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059