Description

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.

Learning Objectives:

• 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.

Complimentary Hand-outs (Value US$ 649.00):

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 (Value: US$ 649)

• 50-Page primer: FDA GMP Compliance in Analytical Laboratories
• Laboratory Compliance Master Plan
• Worksheet – Laboratory Audits
• Following Standard Operating Procedures:

1. Corrective and Preventive Actions (s-114)
2. Handling Out-of-Specification Results (s-115)
3. Handling Out-of-Trend Situations (s-116)
4. Qualification of Equipment (e-240)
5. Validation of Spreadsheet Applications (e-264)
6. Retention and Archiving of Electronic Records (e-315)
7. Generation and Maintenance of SOPs for Laboratories (S-504)
8. Change control of analytical equipment (s-509)
9. Auditing Analytical Laboratories (s-511)

1. Review and Approval of Analytical Test Results (s-512)
2. Training for Laboratory Personnel (e-513)
3. Purchasing and Receipt of Supplies for Laboratories (s-514)
4. Quality Assessment of Laboratory Suppliers (s-515)
5. Risk Assessment for Laboratory Systems (e-519)
6. Laboratory Complaint Handling (s-520)
7. Subcontracting of Testing and Calibration (s-522)
8. Laboratory Failure Investigations (e-530)
9. Preparation of Laboratory Working Standards (s-532)

1. Handling of Laboratory Test Samples (s-534)
2. Reserve Samples in Laboratories (s-535) NEW
3. Maintenance of Laboratory Equipment (s-541)
4. Validation of Analytical Methods (s-612)
5. Validation of Chromatographic Methods (s-613)
6. Handling (Certified) Reference Material (s-625)
7. Calibration of Analytical Balances (s-641)
8. Qualification of Refrigerators (s-644)
9. Validation of Laboratory Computer Systems (s-656)

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, Labcompliance

Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences.

He served as a 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 equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press.

• 08.30 AM - 09.00 AM: Registration
• 09.00 AM: Session Start
• 09:00 - 09:45: 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
• 09:45 - 10:30 (*): 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
• 10:30 - 11:00: Break
• 11:00 - 12:00 (*): 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
• 12:00 - 12:30 (*): 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
• 12:30 - 13:30: Lunch
• 13:30 - 15:00: 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
• 15:00 - 15:30: Break
• 15:30 - 17:00 (*): 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 compendial methods according to USP <1226>
  • Transfer of analytical procedures according to the new USP <1224>

• 08:30 - 09:00 AM: 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
• 09:00 - 10:00 (*): 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
• 10:00 - 10:30: Break
• 10:30 - 11:15 (*): 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
• 11:15 - 12:00: Training for GMP compliance
  • FDA requirements
  • identification of training needs
  • Developing a training plan
  • Making GMP training interesting
  • Documenting effectiveness of training
• 12:00 - 13:00: Lunch
• 13:00 - 14:30 (*): 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’
• 14:30 - 15:00: Break
• 15:00 - 16:15 (*): 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
• 16:15 - 16:30: Wrap up – Final questions and answers