Training

QUALITY & COMPLIANCE SOLUTIONS

We offer GCP/GMP/GLP professional training platforms with online enabling tools for government regulated diversified healthcare products. Outsourcing cost-effective options include quality & compliance and industry-relevant workshops at our International Training Center in Shanghai, as well as on-site customized professional training courses. Our professional trainings and workshops are conducted in the language of the market we serve.
Our Training Workshops can assist in the preparation for International and 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

Continuing Education For Continuous Improvement

We specialize in providing on-site technology-based professional training services in the local language. Our training options also offer classroom-based with proprietary training tools and products in the language of the market we serve.

Our Training Team is comprised of:

  • Former FDA-EMA inspectors
  • Former FDA-EMA scientific and medical reviewers
  • Former Scientific Experts from U.S. National Institutes of Health (NIH)
  • Pharmaceutical, medical device and diagnostics Industry Experts

GCP Workshop

Our GCP workshops are designed for professionals who are working or intend to work in clinical trials, project management, regulatory, and quality & compliance. Our various training courses help companies to improve the management of clinical trials, understand local and international technical requirements, as well as improve the capacity of our students.

Participants

  • Professionals working in pharmaceutical, biotech, medical device and veterinary companies
  • Hospital personnel involved in clinical trials
  • College graduates intending to work as a Clinical Research Associate or interested in clinical trials

Topics include:

  • Overview of responsibilities in Clinical Development from FDA perspective
  • Update of regulations, guidance and principles that govern clinical investigations
  • FDA investigations of sponsor, CRO, clinical investigator
  • US IND regulations and process
  • Strategies for planning, preparation and management of different types of FDA GCP inspections
  • Strategies for development of responses to FDA deficiencies and letters
  • Current FDA issues and enforcement actions

Customize Your Training Program

The above is just a sample of all the topics we offer. We will customize the topics according to your needs. We also offer online training software for all of our training courses. For details, please call or send email :
Phone: (8621) 2422-5226
info@csrpharmsvcs.com

GMP Workshop

Our GMP workshops are designed for managers, supervisors and operators involved in manufacturing and operations of the factory. With regular training, we can help every personnel in the factory to understand the operating procedures and the regulatory requirements of GMP.
We tailor our training courses for both the management team and the production workers in the factory in China. We offer low-cost, high-quality technology based training options according to the specific needs of our clients.

Topics include

  • Overview of responsibilities in product manufacturing
  • Discussion of key regulations, guidance and principles that govern product manufacturing and other GMP functions
  • How FDA conducts inspections of Sponsor and CMO for different types of manufacturing facilities
  • Strategies for planning, preparation and management of different types of FDA GMP inspections
  • Strategies for development of response to FDA deficiencies and warning letters
  • Strategies for development of responses to FDA deficiencies and letters
  • FDA enforcement policies and procedures
  • FDA enforcement actions

Customize Your Training Program

The above is just a sample of all the topics we offer. We will customize the topics according to your needs. We also offer online training software for all of our training courses. For details, please call or send email :
Phone: (8621) 2422-5226

info@csrpharmsvcs.com

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Office

  • 991 US Highway 22 West,
    Suite 200 Bridgewater, NJ 08807
  • (closest airport is Newark Liberty International airport)

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