Some of Our 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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The way this class was put together caused us to review GMP activities that needed to be reviewed, but the review was very entertaining and the game format made us try very hard to understand the content to win the game. It is by far the best refresher I have attended, both for learning and wanting to participate – it really made us think hard!
This team was a great example of working together, cross functionally, to achieve a goal. We have a complete URS for the LMS, and a foundation at all of the sites to build upon. This team was a key enabler to make this a reality and we learnt much from this.
You have an impressive skill set and an ability to bring clarity out of confusion.
You have an impressive skill set and an ability to bring clarity out of confusion.
We have a new corporate standard for training – Joanna!
I can’t say enough about Joanna – how do you maintain this high level of enthusiasm for each class?
I have to say thank you – our client took a class of yours on training systems, and they have used a lot of your principles – thanks to you, they have a good foundation, which has made this project easier.
One of the best programs I’ve attended – I have been to many different training programs and the worst was said to be GMP – this course has proven that wrong!
You spoke in terms of ‘we’, not ‘you’ – this was important for the content.
You did a great job keeping things on track, but still allowing discussion and questions.
Most valuable part to me was the complete overview of why we must do certain things. I have been with the company for 28 years, and I knew WHAT we needed to do – now I know WHY.
You helped set the direction and established many key processes including the foundation for an onboarding program that is becoming the global standard for our company.
Thanks for being SO easy to work with – wish all consultants could be like you!
You have done it – you’ve found a way to make refresher interesting. Congratulations!
Your project is something that can be studied by the company and used as a model for future change.
Joanna is the complete package – she can do it all. From the day-to-day detail work to identifying improvement needs and developing strategy for the future, designing and delivering training to planning LMS upgrades and the associated validation work – if I need it, she can do it, and do it well. She’s one of a kind!
Joanna is one of the best GMP instructors around, if not the best.
This course has changed my life – I didn’t know if quality work was for me because it was so overwhelming, but through this course you’ve provided me enough understanding to show me the value of quality and given me enough confidence in my understanding of GMP that I know I can continue to learn what the requirements are.
Your presentation got me excited about GMPs – which I won’t admit to too many people!
Joanna is very down-to-earth and speaks to you and with you, not at you.