FDA INSPECTIONS WITH PHONIZE
E-Submissions and Data Standards for FDA Regulated Companies from PHONIZE, USA
Now on Mobile Devices
FDA INSPECTIONS WITH PHONIZE
E-Submissions and Data Standards for FDA Regulated Companies from PHONIZE, USA
Now on Mobile Devices
Each FDA center employs varied but specific guidelines and processes for a successful submission within the regulatory review of a medical product. The submission process for drugs, biologics and medical devices is especially rigorous.
In order to better the submission process nationally and worldwide, Different Standard Development Organizations such as the HL7, ISO, CDISC, and ICH work hard to produce and harmonize standards.
WHAT YOU WILL LEARN
This course will train you in the new and expected guidelines on data standards and electronic submissions for drugs and medical products. This includes submission policies and requirements in the USA and globally, and how these policies will directly and indirectly affect your company.
AVAILABLE LEVELS
BASIC & INTERMEDIATE
TOPICS COVERED
- An overview of the approval process for drugs, biologics and devices
- Complete FDA submission requirements
- Globaly E-submission basics
- How to prepare an Electronic Common Technical Document
- A primer on;
- The International Conference on Harmonization (ICH),
- Health Level 7 Regulated Clinical Research Information Management
- Clinical Data Interchange Standards Consortium
- Biomedical Research Integrated Domain Group
PERFECT FOR
- Management (Pharma, Biotech)
- Policy analysts
- Government officers
- Health IT Managers and Analysts
- Research and Development (Pharmaceutical, Academia)
- Regulatory Affairs personnel
- Quality assurance/quality control personnel
- Auditors and inspectors
- Entrepreneurs Investors
- Consultants
- Regulators
“Our quality managers enjoyed using PHONIZE and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Expertly implemented submission protocols provide simplicity, improve overall submission quality, reduce negative reviews, and improve licensing consistency.
Delivers expert advice on and a full picture of electronic submissions and data standards for medical product manufacturers.
Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
Provides skill-building and leadership training for regulated industry professionals with RAPS credit — available now on Mobile Devices.