Training Programs

MWA provides customized and standardized training on a wide variety of GXP topics. Training programs are continuously updated so that the training reflects current regulatory standards. Formats include onsite, webinars, and teleconferences. The length of time will be determined by the detail of the program and customization per client needs. For pricing and additional information, contact Lisa Helmonds.

Training Topics

These are examples of the types of programs we offer. If you are interested in these are additional topics, contact us!

Aseptic Techniques

  • Review the GMP requirements for aseptic practices
  • Reinforce the use of aseptic practices in the clean room during the manufacturing process

CGMP for Phase I Investigational Drugs

  • Review and interpret FDA guidance
  • Discuss where controls are needed
  • Identify what is non-negotiable for Phase I investigational drugs

Data Integrity: The Roadmap to Compliance

  • Key Terms and Concepts
  • Regulatory Requirements and Considerations
  • Training and Self Audits
  • Management Governance, Culture, Risk Assessments, Data Governance, Technology and Validation, Procedures and Processes, FDA Warning Letters, ALCOA+

Effective Writing

  • Implement a standard writing style and format
  • Sharpen your document reading and writing skills
  • Effect a cultural change in how documents should be written and used
  • Develop effective, user-friendly and GMP compliant documents
  • Hands-on SOP writing

Equipment Qualification

  • Learn key terminology related to validation and qualification of equipment, processes, and facilities
  • Establish proper IQ, OQ, PQ documents
  • Develop a standardized approach to report writing
  • Establish key elements of change control

Ethics in Clinical Trials

  • Reviews history of ethical principles in Clinical research
  • Reviews failures in clinical trials
  • Discusses warning letter observations
  • Reviews how to detect fraud during a GCP audit

Failure Investigations

  • Improve your ability to write a failure investigation
  • Minimize regulatory liability by learning how to appropriately document findings
  • Enhance your understanding of what FDA expects to see from a failure investigation system
  • Hands-on investigation and documentation of a GMP manufacturing failure

FDA QSIT Audit Approach

  • Review the FDA QSIT approach to inspection for pharmaceuticals
  • Understand the FDA requirements expected for each quality subsystem
  • Review the FDA rating system for failures in the quality system and the implications

FDA Regulations (GMP, GCP, GLP)

  • Overview of quality and requirements for working in a regulated industry
  • Overview of CGMP, GLP, GCP regulations and practical interpretation of the requirements
  • Review of pertinent 483 observations related to either cGMPs, GLPs or GCPs

GMP/QSR Training

  • Overview of cGMP, QSR, or a combination of both regulations
  • Understand key definitions
  • Review of pertinent 483 observations

GMPs in Research and Development

  • Understand what the GMP requirements are within research and development
  • Review how the GMPs evolve through the development process
  • Provide an overview of data integrity
  • Learn how to provide a solid basis for development documentation that serves as the foundation for the development history report
  • Review and discuss Warning Letters

Great Documentation Practices

  • Increase your awareness of FDA requirements
  • Improve your documentation skills
  • Reinforce that documentation is part of your job
  • Enhance your understanding of compliance
  • Hands-on documentation exercise

Interacting with the FDA

  • Interacting with the FDA
  • Discuss what the FDA looks for during an inspection
  • Review key techniques for effectively interacting with the FDA
  • Provide the “do’s” and “don’ts” of interacting with the FDA

Internal and External Auditing Techniques

  • Prepare, conduct, and follow-up on internal audits.

ISO 13485

  • Review ISO 13485 in detail and discuss the outputs based on the requirement

Labeling, Advertising, and Promotion of Medical Products: What CAN I say?

  • Labeling, advertising, promotion, product claims
  • Off-label promotion: what’s allowed, what isn’t
  • Review of warning letters related to advertising/promotional practices
  • How to prevent off-label advertising/promotional practices

Methods Validation

  • Review method validation requirements per ICH guidelines

Monitoring for Clinical Excellence

  • Good documentation practices
  • Putting it all together

Pre-Approval Inspection Preparation

  • Importance of GMPs in development and transition to commercialization
  • Techniques for assuring data integrity and accuracy
  • Key preparatory activities:  NDA through PAI
  • Understand your responsibilities as a Sponsor

Regulations for Virtual Companies

Risk Management

  • FDA and Risk in the 21st Century
  • ICH Vision
  • Key Definitions
  • ICH Q9
  • Risk Management and Patient Safety
  • Risk Based Methodology
  • Risk Based Tools
  • Hands-On Risk Exercises