Training
Lachman Consultants is committed to helping ensure clients' long-term success and effectiveness with compliance and regulatory issues, as well as regulatory affairs. To that end, we offer a full complement of training programs for all levels of an organization, from senior executives to bench chemists and manufacturing operators. Our training programs can be customized to meet each organization's requirements. In addition to classroom training, we are also able to deliver on-the-job training and "train the trainer" services. Examples of some of the training programs that we offer are as follows:
Essential Programs for Senior and Mid-Level Management
- Corporate and Individual Responsibility and Legal Liability for Compliance
- Risk Management — The New Frontier
- 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 Approaches to Product Development, Quality Evaluation and Clinical Assessment
- Combination Drug Products and Medical Devices
- Regulatory Aspects of Life Cycle Management
- 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
- Regulatory Requirements and Expectations for Good Clinical Practices
- Inspection of Bioanalytical Laboratories
