Introduction to Good Manufacturing Practices
This course will cover the basics of Good Manufacturing Practice requirements. The student will acquire a knowledge of the history of the regulations and their enforcement. An outline of the topics covered by 21 CFR Parts 210 and 211 is followed by an in-depth discussion of specific requirements.
Implementing a Risk-Based Approach for FDA-Regulated Systems, Products and Processes
Now more than ever, determining the risk associated with a product, process or system makes sense from both a business and a regulatory point of view. FDA recommends that companies address those requirements of 21 CFR 11 toward which it intends to exercise enforcement discretion by performing and documenting a risk assessment. In addition, the future of cGMP compliance dictates that companies take a science-based risk management approach to ensure product quality and public safety while facilitating the use of new and innovative technologies in bringing the product to market.
Stelex University’s new course, Implementing a Risk-Based Approach for FDA-Regulated Systems, Products and Processes, is designed to help you develop those skills necessary to make informed risk-based decisions impacting your customer and your organization. This three-day program will provide you the opportunity to examine a variety of risk assessment approaches in depth in a relaxed, workshop-style atmosphere. Numerous exercises throughout the session give you the opportunity to apply these approaches to a number of real-world scenarios. The cost of this 2-day course is $1340.
Introduction to the CSV/SLC
A typical software system life cycle provides the backdrop for a discussion of computer systems validation (CSV) concepts and terminology in the context of an FDA-regulated environment. Attendees will be first given a brief history of the FDA in order to understand its authority and institutional mandate. Comparison and contrast between those regulations and ISO and GAMP3 standards are elaborated.
How the FDA Conducts Investigations
Attendees are guided through the process of an FDA investigation and a company’s response to that investigation. Initial activities include the investigator’s preparation and arrival at the facility to be investigated. Particular focus is given to the various inspection methods employed by investigators: direct observation, review of documentation, sampling, interviews, affidavits, photographs, and audio/video recordings. The process of issuance of inspectional observations (483s) and Warning Letters is detailed. A suggested course of conduct for response to FDA investigations – including the rights of the company under investigation – is presented. Emphasis is placed on the need to identify and assign key personnel to handle various aspects of the investigation.
CSV Overview / Introduction to CSV
A typical software system life cycle provides the backdrop for a discussion of computer systems validation (CSV) concepts and terminology in the context of the requirements for CSV in the FDA’s cGMP for Finished Pharmaceuticals (21 C.F.R. §§ 210-211), Quality System Regulation (21 C.F.R. § 820), and Final Rule for electronic records and electronic signatures (21 C.F.R. § 11). Attendees will be first given a brief history of the FDA in order to understand its authority and institutional mandate. Comparison and contrast between those regulations and ISO and GAMP3 standards are elaborated.
Writing a System Requirements Specification
This course will provide the student with the information necessary to write a System Requirements Specification (SRS). This is an important document in the development of a computer system, in that all design elements and software test protocols are developed based on the requirements for that system. In addition, attendees will learn how to begin a Requirements Traceability Matrix, which will be updated throughout the system life cycle.
Designing and Performing a Risk Analysis
This course examines a practical method for designing and performing a Risk Analysis as it pertains to software. Attendees are guided through associating values of risk factors with specific software functions and estimating a risk index. Mitigation techniques for high-risk software functionality are also discussed.
Writing a System Design Specification
This course guides the student through the development of System Design Specification (SDS). This SDS will guide the actual development and implementation of functionality into the subject application.
Writing an IQ/OQ/PQ
This course will provide attendees with a comprehensive understanding of what should be included in a computer systems Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualfication (PQ).
Writing and Executing Validation Test Protocols / Writing a Validation Summary Report
The course will provide attendees with a comprehensive understanding of the elements of a computer system’s installation qualification (IQ) and Operational Qualification (OQ) as well as other testing. Guidelines for the development, execution and documentation of test protocols will be covered. Particular focus will be given to the reporting and resolution of errors encountered during test execution. Finally, attendees will learn to identify and document the critical elements of a validation summary report.
Writing a Retirement Plan
This course guides the student through the evolution of those processes that create, develop and establish the validation requiremtns for retiring a computer system.
Writing a System Management Plan
This course guides students in the development of a System Management Plan (SMP), which serves as a single reference point for procedures governing system operation.
“More than a Checklist”: Quality Auditor Training
Attendees will:
· Practice using a versatile auditing strategy that is applicable to any type of audit
· Learn to implement effective auditing techniques during practical role playing exercises
o Characterize and set the scope of an audit
o Prepare audit schedules and forms
o Conduct opening and closing meetings
o Ask the right questions of auditees and evaluate the responses
o Follow up with the auditee and audit sponsor
o Apply practical tips, gleaned from years of diverse instructor experience, to conduct a successful audit that meets the goals of all participants
Applying a Project Management Methodology to Validation Projects
Attendees will:
· Understand the differences among the work effort required for prospective, retrospective and remedial validation efforts
· Learn the unique aspects of each validation deliverable that could impact the project plan, project schedule and budget
· Construct a statement of work, project plan and schedule for a validation project
· Learn how to assemble a validation project team
· Learn how to address communication, staffing, procurement, budgeting issues
· Gauge the risks associated with the validation activities and the validation project as a whole
Compliance & Remediation Strategies for 21 CFR § 11
An intensive one-day session for professionals in FDA-regulated industries, this course examines the controls required on computer systems and software under the FDA's final rule for electronic records and electronic signatures (21 CFR Part 11). Strategies and methodologies for performing Part 11 assessments and audits are presented along with case studies of actual assessments performed. Particular focus is given to compliance and remediation efforts, including software and documentation solutions. The most recent FDA inspection and enforcement trends of Part 11 non-compliances are discussed along with current trends in Federal and state regulation of electronic record and electronic signatures. A full survey of Electronic Records and Signatures is examined (including such issues as controls for Closed Systems, Controls for IDs/Passwords) along with Application of Part 11 and Compliance Strategies. The course also examines present and future trends in Electronic Records and Signatures. Frequently asked question on 21 CFR part 11 are also addressed. Familiarity with Part 11 and its definitions is beneficial, but not critical for attendess.
Introduction to Process Validation
Attendees will:
· Understand the regulatory basis for Process Validation
· Learn and apply the fundamental practices and principles of Process Validation through in-class exercises
o Pilot Scale-up and Production
o Process Capability Design, Testing, and Analysis
o Determination of Control Limits
o Pareto Analysis of Process Defects
o Optimization Techniques
o Process Capability Studies
o Bioavailability Determination
o Process Step Evaluation/Optimization
The Changing Face of 21 CFR §11
Attendees will:
· Understand the current interpretation and enforcement of Part 11
· Learn how to perform Part 11 assessments and auditsPractice developing Part 11 compliance plans and remediation strategies
· Evaluate vendor product claims of Part 11 compliance
· Practice developing and implementing a Part 11 validation strategy
· Learn to overcome common Part 11 validation obstacles
· Learn to assess their networks and infrastructure to determine actions needed to bring systems into compliance with the Part 11 and predicate rules
Maintaining Computer Systems in a Validated State: A Risk-Based Approach
Attendees will:
- Understand the business and regulatory reasons for maintaining a computer system in a validated state
- Learn how to establish policies and programs to support system maintenance
- Obtain management buy-in
- Identify who needs to be involved in the process
- Prioritize system maintenance activities based on business and regulatory risk
- Learn how to develop and document maintenance phase activities
- System Maintenance Plans
- Backup, Restoration, and Archival procedures
- Disaster Recovery Plans
- Change Control and Configuration Management documents
- Startup/Shutdown Procedures
- Physical/Logical Security procedures, administration, documentation
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