Training

Lachman Consultants is committed to helping ensure clients’ long-term success and effectiveness with compliance and regulatory issues, as well as regulatory affairs. Lachman 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, Lachman is also able to deliver on-the-job training and “train the trainer” services.

These are some of the training programs Lachman 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
  • FDA Pre-Approval Inspections
  • Preparing for an Inspection and Interacting with the Investigator
  • Integrity of Records and Data
  • GMP’s 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 Programs

  • 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