Description:
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects.
The following steps to establish the appropriate manufacturing environment for phase 1 investigational drugs should be taken:
- A comprehensive and systematic evaluation of the manufacturing setting (i.e., product environment, equipment, process, personnel, materials) to identify potential hazards
- Appropriate actions prior to and during manufacturing to eliminate or mitigate potential hazards to safeguard the quality of the phase 1 investigational drug
Review the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.
The following topics will be discussed to provide the foundation and basis for advancing drugs into clinical development from research and providing required information to the FDA regarding these products.
- Overview of Good Manufacturing Practices
- GMP Requirements for a Phase 1 Study
- Personnel
- QC Function
- Facility and Equipment
- Control of components, containers and closures
- Manufacturing & Records
- Laboratory Controls
- Vendor selection & management
- Process Validation
- Special Considerations
- Multi-product facilities
- Biologics
- Sterile products
- Combination products
- Providing relevant information in the IND application
Course benefit:
This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
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Learning Objectives:
To gain an understanding of the requirements for drugs entering into phase 1 clinical development and the minimum FDA requirements for phase I GMPs. To learn practical applications for implementing manufacturing and quality strategies to meet FDA requirements.
Areas Covered:
Day 1 Topics
- Overview of GMP requirements
- GMP Requirements for a Phase 1 Study
- Personnel documentation and requirements
- QC Function procedures and requirements
- Facility and Equipment requirements
- Control of components, containers and closures – methods and specs
- Manufacturing & Records during phase 1 studies with an eye toward later development
Day 2 Topics
- Vendor selection & management
- Process Validation to conduct for phase 1 clinical supply process
- Specific requirements for various types of products: biologics, combinations, sterile products
- Multi-product facilities considerations
- Preparing relevant SOPs for early stage development
- Providing relevant information in the IND application
Who will Benefit:
- Directors
- Manager
- Supervisors
- Lead workers in Regulatory Affairs Quality Assurance and Quality Control
- Workers who will prepare GMP documents for early phase products
- Workers who will review GMP documents for early phase products
Speaker: Mukesh Kumar,
Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.
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