CSR Pharma Services

Training

QUALITY/COMPLIANCE TRAINING

We offer training programs that include Quality/Compliance and industry-relevant Technical Workshops at our International Training Center in Shanghai CHINA. Our Workshops and courses are conducted in the language of the market we serve.

Our Workshops and courses can assist in preparation for the U.S. professional certification exams. The Quality Workshops are qualified for American Society for Quality (ASQ) recertification units (0.8 RU per 8 hour per day) www.asq.org. The U.S. Regulatory Workshops are qualified for U.S. Regulatory Affairs Professional Society (RAPS) recertification points (6 points per 8 hour per day) www.raps.org.

As was well said in an Ancient Chinese Proverb, "A journey of a thousand miles must begin with a single step."

US REGULATORY & MARKETING APPROVAL WORKSHOP
The intensive TWO-DAY Workshop is designed for professionals who would like to have a knowledge and understanding of U.S. Regulatory and successful Marketing Approval. The course is especially designed for employees working in pharmaceutical and biotech companies, who are involved in R&D, manufacturing, marketing, business development, and general management.
The Workshop content includes an overview of the regulatory and product development process that occur to ensure a successful launch. Topics include:
- US government regulations impacting modern pharmaceutical Drug Development
- Development of regulatory strategy
- Global harmonization of pre-clinical, animal testing requirements
- Overview and rationale of Clinical Research program for product development
- US IND regulations and process
- US NDA regulations and process
- US FDA communications and negotiations for review and marketing approval
- Essentials for successful Product Labeling
- Patents and Exclusivity Update
Workshop Registration
For Workshop dates and agenda, Registration Form, payment information, group rate and any other questions, please call or send email to Grace Fang grace@csrpharmsvcs.com.
QUALITY/COMPLIANCE: FDA INSPECTION, GCP CLINICAL TRIALS AND DEFICIENCIES WORKSHOP
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The ONE-DAY Workshop is designed for professionals, who would like to have a knowledge and understanding of the US FDA perspective regarding Clinical Development and GCP issues. The course is especially designed for professionals, who are working in pharmaceutical, generic, biotech, medical device and veterinary companies, or who have responsibilities in Clinical R&D, project management, regulatory, quality/compliance, or outsourcing management.
The Workshop content includes an update of GCP issues and US FDA perspective of foreign studies in Asia Pacific, as well as development of strategies for planning, preparation and organization for different types of FDA GCP inspections. Topics include:
- Overview of responsibilities in Clinical Development from FDA perspective
- Update of regulations, guidances and principles that govern clinical investigations
- FDA investigations of sponsor, CRO, clinical investigator
- Strategies for planning, preparation and management of different types of FDA GCP inspections
- Strategies for development of responses to FDA deficiencies and letters
- Fraud and misconduct using case studies
- Current FDA issues and enforcement actions
The FDA Workshop is given in cooperation with the Shanghai Municipal FDA (SHFDA)/ Institute for Food and Drug Safety. PHARMA CHINA/WICON www.pharmachinaonline.com is a media partner of the event .

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Workshop Registration
For Workshop dates and agenda, Registration Form, payment information, group rate and any questions, please call or send email to Grace Fang grace@csrpharmsvcs.com. Registration deadline is two weeks prior to the date of the event.

Continuing Education for Continuous Imprevement

We specialize in providing in-house Quality/Compliance training services at the supplier/vendor sites. Our courses are classroom-based with high-tech training tools and products in the language of the market we serve.

Our Training Team is comprised of:

former FDA Inspectors
former FDA Pre-Approval Managers
former Clinical Research Center (CRC) specialists from US National Institutes of Health (NIH)
US pharmaceutical, biotech & food industry executives

with 15-20 years of compliance experience, successful product development and marketing approvals, and/or global inspection experiences.

The FDA Centers, which are located in Washington, D.C., include the following: Center for Drug Evaluation and Research CDER (drugs, generics, over-the-counter OTC products); Center for Biologics Evaluation and Research CBER (biological products such as vaccines); Center for Devices and Radiological Health CDRH (devices); Center for Food Safety and Applied Nutrition CFSAN (food); Center for Veterinary Medicine CVM (animal products). Each Center has its own unique mission and organization chart with FDA Reviewers, who are responsible for the review and approval of clinical trial and marketing applications.

The FDA Inspection team belong to different organizations within the FDA and is primarily based in the FDA District Offices, which are located across the U.S.

Our Definitions

FDA Bioresearch Monitoring (BIMO) Program specialists are FDA Inspectors, who are primarily dedicated to investigations of clinical studies, pre-clinical laboratories, and other aspects of research.

FDA Pre-Approval Managers have worked as FDA Inspectors and promoted to take responsibility for final approval of investigations for all aspects of research included in the marketing application. Their decisions are communicated to the Review Divisions at the FDA Centers in Washington, D.C.

US National Institutes of Health (NIH) Clinical Research Center (CRC)specialists have worked at the NIH-supported Clinical Research Centers, which are located primarily in major teaching hospitals across the U.S.

US pharmaceutical/biotech/food executives, who serve as instructors, have 15-20 years of work experience in the FDA-relevant industry in the U.S., including Big Pharma or other large companies in the U.S.

Training

US REGULATORY & MARKETING APPROVAL WORKSHOP

QUALITY/COMPLIANCE: FDA INSPECTION, GCP CLINICAL TRIALS AND DEFICIENCIES WORKSHOP