Training

TSI CONSULTANTS SERVICES

Training

TSI Consultants is committed to helping ensure clients’ long-term success and effectiveness with compliance and regulatory issues, as well as regulatory affairs. TSI Consultants offers a full complement of training programs for all levels of an organization—from senior executives to bench chemists and manufacturing operators.

Training programs can be customized to meet each organization’s requirements. In addition to classroom training, TSI is also able to deliver on-the-job training and “train the trainer” services.

These are some of the training programs TSI Consultants offers:

Essential Programs for Senior and Mid-Level Management

Corporate and Individual Responsibility and Legal Liability for Compliance
Risk Management — The New Frontier

GMP Programs

GMP training for manufacturing and laboratory personnel
Overview of GMPs for the 21st Century
Risk-Based GMP Inspections
DRAP Pre-Approval Inspections
Preparing for an Inspection and Interacting with the Investigator
Integrity of Records and Data
GMPs for Dietary Ingredients and Dietary Supplements

Regulatory Programs

Regulatory Approaches to Product Development, Quality Evaluation and Clinical Assessment
- Combination Drug Products and Medical Devices
Regulatory Aspects of Life Cycle Management

Generic Drugs Program

Introductions to Generic Drug Development
Regulatory Requirements for ANDA Products
Overview of the Hatch-Waxman Act, Implementing Regulations and Recent Legislative Amendments
Patent Certification and 180-Day Exclusivity, and Forfeiture

Clinical/Bioanalytical Programs

Regulatory Requirements and Expectations for Good Clinical Practices
Inspection of Bioanalytical Laboratories

PHARMACEUTICAL

TSI Consultants has an unsurpassed reputation for excellence in technical, regulatory consulting

PHARMACEUTICAL

TSI Consultants is proficient in the development, implementation, and management of diversified projects involving compliance, scientific principles, technical aspects, and regulatory requirements related to pharmaceutical products.

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Medical Device

TSI Consultants comprehensive list of services extends to all classes of medical device.

Medical Device

TSI Consultants comprehensive list of services extend to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.

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BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation,

BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.

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