Training

Agile Pharmaceutical Solutions is committed to clients’ long-term success by offering a full complement of training programs for all levels of an organization from laboratory and manufacturing personnel to senior executive. Each training program, either classroom or on-the-job, is customized to meet your organization’s requirements. We offer these dynamic and interactive trainings at your location and off-site. We help your company stay compliant and up-to-date with FDA, Health Canada, ICH, ISO, DEA, and MHRA.

Our instructors are experts in their subject and bring many years of experience working with various industries and government organizations including FDA and Health Canada.

These are some of the training programs APS offers:

  • - Corporate and Individual Responsibility and Legal Liability for Compliance

  • - GMP training for Manufacturing and Laboratory Personnel

  • - Overview of GMP,GLP, GCP and OSHA

  • - Risk-Based GMP Inspections

  • - FDA Pre-Approval Inspections

  • - Integrity of Records and Data

  • - GMP for Dietary Ingredients and Dietary Supplements

  • - Regulatory Programs

  • - Project Management Professionals (PMP)

  • - Regulatory Approaches to Product Development, Quality Evaluation and Clinical Assessment

  • - Combination Drug Products and Medical Devices

  • - Introductions to Generic Drug Development

  • - Regulatory Requirements for ANDA Products

  • - Overview of the Hatch-Waxman Act and Recent Legislative Amendments

  • - Patent Certification and 180-Day Exclusivity

  • - Clinical/Bioanalytical Programs

  • - Regulatory Requirements and Expectations for Good Clinical Practices