Training

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 thinking. Training is available via teleconference or onsite based on your needs. Download our course descriptions or view them below.

MWA Course List:

Aseptic Techniques

Course Objectives:

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

1.5 hours

CGMP for Phase 1 Investigational Drugs

Course Objectives:

  • Review the new guidance document issued by FDA and what it means
  • Interpretation of the guidance
  • Discuss where controls are needed
  • Identify what is non-negotiable for Phase 1 investigational drugs

1 hour

Effective Writing

Course Objectives:

  • 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

4 hours/8 hours with workshop

Equipment Qualification

Course Objectives:

  • 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

1 day

Ethics in Clinical Trials

Course Objectives:

  • 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

1 hour

Failure Investigations

Course Objectives:

  • 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
  • Workshop: Hands-on investigation and documentation of a GMP manufacturing failure

2.5 hours/4 hours with workshop

FDA QSIT Audit Approach

Course Objectives:

  • 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

2.5 hours

FDA Regulations (GMP, GCP and GLP)

Course Objectives:

  • 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

Length of time detemined by the detail of the program and customization per client needs

GMP/QSR Training

Course Objectives:

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

Length of time determined by the detail of the program and can be customized to your needs

GMPs in Research and Development

Course Objectives:

  • 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

2 hours

Great Documentation Practices

Course Objectives:

  • 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

2 hours/4 hours with documentation practice

Interacting with FDA

Course Objectives:

  • 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

1.5 hours

Internal and External Auditing Techniques

Course Objectives:

  • We train your audit team to prepare, conduct, and follow-up internal audits. We reference your SOPs and can provide supervised practice time for new auditors.

Length of time determined by the detail of the program

ISO 13485:2003

Course Objectives:

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

2 hours

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

Course Objectives:

  • Covers 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

1 hour

Methods Validation

Course Objectives:

  • Review method validation requirements per ICH guidelines

1.5 hours

Monitoring for Clinical Excellence

Course Objectives

  • Validation- what, why, when and how
  • Good documentation practices
  • Putting it all together

1 hour