FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials by ComplianceOnline
In-Person Event
May 03 - 04, 2018
Tampa, Florida, USASpeakers
OVERVIEW
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials is organized by ComplianceOnline and will be held during May 03 - 04, 2018 at Tampa Marriott Westshore, Tampa, Florida, United States of America.
Course 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 phase 1 investigational drug
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.
Conference Objectives are :
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.
Additional details will be posted as soon as they are available.
Course 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 phase 1 investigational drug
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.
Conference Objectives are :
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.
Additional details will be posted as soon as they are available.
KEY DATES
03 May, 2018
Event Start Date
04 May, 2018
Event End Date
SPECIALITIES
Pharmacy and MedicineSUGGESTED HOTELS
CONFERENCE VENUE
Tampa Marriott WestshoreRELATED CONFERENCES & LIVE WEBINARS
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