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
Day 1 Schedule:
Lecture 1: FDA Regulations and Requirements Overview
• FDA 21 CFR Part 211 and 21 CFR Part 11
• Most frequently cited FDA 483s and warning letters
• Requirements overview from sampling to archiving
• Quality system requirements, e.g., ICH Q10
• The concept and practice of risk based compliance
Lecture 2: Planning for quality and cGMP compliance
• Developing and using a validation master plan
• Scope, objectives and key elements of the master plan
• Developing and using FDA compliant SOPs
• Using templates to generate inspection ready documentation
• Planning for efficiency cost-effectiveness
Lecture 3: Calibration and Qualification of Laboratory Equipment
• FDA requirements
• USP chapter <1058> for instrument qualification
• Going through examples for qualification steps(DQ, IQ, OQ, PQ)
• SOPs and deliverables for three instrument categories
• Developing calibration and qualification protocols
Lecture 4: Equipment Maintenance and Change control
• Preventive maintenance; tasks, documentation
• Planned and unplanned changes
• Changing hardware, firmware, documentation
• Definition and handling of like-for-like changes.
• Requalification: time and event based
Lecture 5: Validation of Laboratory Computer Systems
• Going through the new GAMP® guide: "A Risk based Approach to Laboratory Computerized Systems"
• Going through a complete laboratory computer system validation from beginning to end
• Integration the GAMP® guide with USP <1058>
• Periodic evaluation to reduce revalidation efforts
• Revalidation: why, what, when
Lecture 6: Validation of Analytical Methods and Procedures
• Parameters and tests according to ICH Q2
• Developing a validation plan, protocols and a report
• Setting acceptance criteria for different applications
• Verification of compendia methods according to USP <1226>
• Transfer of analytical procedures according to the new USP <1224>
Day 2 Schedule:
Lecture 1: Sample Testing: Preparation, conduct, documentation
• Preparing the equipment
• Setting specifications and acceptance criteria
• Documentation of test results
• Review and approval
• Not to forget: Review of electronic audit trail
Lecture 2: Handling out of specification (OOS) test results
• Going through the FDA OOS guide
• Learning from recent FDA warning letters
• Going through an OOS checklist
• Using out of trend (OOT) data to avoid OOS results
• Documentation and follow-up: root cause, corrective action plan, preventive action plan
Lecture 3: Quality assurance of reference standards and other supplies
• Supplier qualification vs. sample testing
• Selection and assessment of suppliers
• Retesting of materials
• Preparing working standards from reference standards
• Correct labeling of chemicals
Lecture 4: Training for GMP compliance
• FDA requirements
• identification of training needs
• Developing a training plan
• Making GMP training interesting
• Documenting effectiveness of training
Lecture 5: Ensuring Integrity of Raw Data and Other records
• FDA Part 11 and EU-PIC/S Annex 11 requirements
• Definition of Raw Data: Electronic vs. paper
• Acquisition and recording of raw data
• The importance of electronic audit trail
• Archiving of electronic records for 'ready retrieval'
Lecture 6: Internal audits in preparation for FDA inspection
• Scheduling of audits
• FDA Inspections as model for laboratory audits
• Going through a typical FDA laboratory inspection
• Responding to Typical inspectional/audit deviation
• How to avoid FDA 483s and warning letters
Lecture 7: Wrap up - Final questions and answers
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
Register now and save ₹ 2000. (Early Bird)
Price: ₹ 14,000 (Seminar for one Delegate)
Until December 10, Early Bird Price: ₹ 14,000 from December 11 to January 21, Regular Price: ₹ 16,000
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