Sample Consulting Projects

Training System Remediation/Support & OJT Projects

  • Completed an 18-month project (extended twice due to quality of work) to develop & implement a full GMP training system for a client starting up a new site. Site passed FDA inspection with no 483 observations, and 4 current & former FDA investigators reviewed training system and found no gaps/concerns – this training system being installed globally through all of the company’s multinational sites. Work performed included:

Authoring/implementing training system procedures

Managing training function until site training personnel hired, and mentoring of training and other site personnel

Developing/delivering training content on GMP/regulatory topics, including in-depth training on GMP subparts and various FDA guidances (OOS, Quality Agreements, Aseptic Processing, Process Validation)

Designing/delivering onboarding program

Guiding procedure authors through development of training content, knowledge and performance assessments

Providing guidance to area SMEs for development of OJT programs and performance assessment checklists

Providing guidance and support for testing/implementation/rollout of a global LMS

Providing occasional support to/sharing expertise with other global sites.

  • Worked with an internationally-known regulatory consulting firm to guide an international company under regulatory scrutiny through training system remediation, including redesigning their training system, and design/delivery of training materials and sessions, including GMP refreshers and aseptic operator qualification process/materials
  • Led a team through full implementation of an LMS, including authoring validation scripts, system SOPs, and planning rollout
  • Worked with a former client to perform a focus group activity as a follow-up to a previous GMP training course to help the company understand and address operator concerns on the manufacturing floor, including defining the questions to be asked, facilitating the conversations, and documenting, summarizing and presenting the operators’ feedback
  • Worked with a medical device company to develop their training curricula, identify gaps/potential regulatory concerns, and assisted with identifying and launching an LMS, to help the company become QSR-compliant
  • Spoke at a client’s global training meeting on competency-based training program development & implementation, to support global training system remediation in the face of FDA sanctions
  • Managed a client site’s internal training program in the absence of a training manager
  • Worked with a client’s new site/new technology to develop a full GMP training system, including procedures, LMS implementation preparation work, OJT material and new hire orientation program development/implementation & delivery
  • Performed an audit of a client site’s training system, and provided recommendations and a plan for implementing improvements
  • Led the conversion of a client’s LMS assignments over to role-based curricula across multiple, global sites
  • Mentored a newly hired training department through LMS improvements, developing GMP training capability, and improving training system and associated processes/procedures

Training Design & Delivery Projects

  • Developed & delivered a 2-day training on US 21 CFR 803/820 & newly revised version of ISO 13485:2016 to 26 members of the management staff of a medical device company in the U.K, working to remediate US and ANVISA audit observations. Very well received by the audience, positive feedback and comments received from all attendees.
  • Worked with a GTP client to define and design an aseptic operator qualification program
  • Designed a series of training games and word search puzzles in multiple languages for a client to use for GMP training offerings during Global Quality Week
  • Led a client site’s management through a gap analysis comparing their quality systems to ICH Q10 expectations and using risk management to identify high priority gaps, taking a list of recommendations forward to senior management, and getting recommendations incorporated into the site’s annual objectives
  • Led an R&D organization through a risk analysis project for a Phase III PET drug, including designing/delivering three different training programs to prepare personnel to work through the project/risk analysis process
  • Worked with a client to develop an OJT trainer qualification program, subsequently rolling the program out, delivering it across two sites, and qualifying 150 OJT trainers
  • Delivered two different half-day GMP refresher sessions over 5 months focused on developing a quality culture to a global medical device company, with phenomenal feedback from participants and from the client
  • Provided a full Good Documentation Practices and Data Integrity training series (three courses in three weeks) to a client site to address data integrity issues cited in a recent 483, and authored the site’s Good Documentation Practices SOP to meet industry standards
  • Designed an ISO 13485:2003 Overview course and delivered training sessions to a support a client’s QMS certification
  • Developed content and custom activities/games for a client site to use in revitalizing their internal training offerings

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