QA Implementation & Training Services – Canada

QA Implementation & Training Services – Canada

Our historyfav

Implementation

Training

 

Our history

Since 1999, as part of our QMS (Quality Management System) consulting services, we have implemented & audited at least 100 QA programs throughout North America & Australia for organizations of varying size & complexities. During that process, we have gleaned additional practical insights into many other innovative (non-proprietary) techniques to comply to the QA requirements – some of which are rather inexpensive & easy to implement, yet highly efficient & effective.  Over these years, we have developed very good working relationships with inspectors at Health Canada & CFIA.

Over these years (and prior as an employee & manager), ICS Inc. has created, edited, reviewed & audited ~10,000 protocols, SOPs, work instructions, checklists & forms. We have also conducted numerous joint audits with Health Canada & CFIA inspectors – many of which have shared various tips & tricks with us, since we are a third party. (i.e.: things they can share with us, that they can’s directly share with the client / auditee, as that may be perceived as “coaching” and therefore a potential conflict of interest.

QA Implementation for:  GMP / cGMP, GLP, GCP, GPP, ISO 13485 / ISO 13488, Medical Device QMS, ISO 14000, ISO 9000, ISO 17025, HACCP / ISO 22000.

How does one eat an elephant?  Simple – one bite at a time!  We take the entire process and break it down into many smaller sizes, and help assign priorities, along with internal & external resources required. This can include selection and coaching of key internal personnel involved throughout the process

Where we excel, is communicating dry, technical issues in a straight-forward, non-technical manner. We are also very proficient and are able to apply these dry regulations in a practical manner.

We conscientiously focus on ensuring the QA program does not become a paper nightmare – but is a ‘living / adaptive’ program. This takes into account the ever-changing business & technological dynamics, and regulatory environments. The goal includes a system for which you can train new employees more efficiently. This should provide a higher level of assurance for meeting not only your company’s immediate needs, but also your future plans.

Our ultimate goal is to set up your QA program so that you are as self-sufficient as possible, so that you can run the vast majority of it yourselves, on a day-to-day basis. Our services should only then be required only if something new or unexpected arises. (instead of giving you a fish, we teach you how to fish).

No need to reinvent the wheel – we have also developed various template Policies, protocols, SOPs, forms & checklists for some of the more intensive requirements such as Product Recall, Complaint Handling & Investigation, Corrective and Preventive Action (CAPA), Out of Specification (OOS) Investigation, Adverse Reaction Reporting, Performing internal & third party audits, product stability, Creation of Master Production Documents (MPDs) / Master Batch Records, etc. We then just have to tweak them to your specific situation.

QA Implementation & Training

QA Training

Over the years, we have created numerous extensive training modules (in MS PowerPoint). These continually get revised after each time we perform a training session, based on our feedback questionnaires handed out at the beginning of each session. We try to use as many examples direct to your situation, as possible. Where practicable, we also like to throw in light humour.

We often start by providing a general overview of the applicable regulations and corresponding QA requirements for Management & Staff. After that, we can then provide more detailed training to individual departments, regarding their specific QA requirements. We are then sometimes asked to provide more in-depth training to the QA/QC personnel, such as in Complaint Handling & Investigation, Adverse Reaction Reporting, Product Recall, Stability protocols, Security protocols, and how to conduct their own internal & supplier audits, (to name a few). Throughout the entire process, we provide hands-on coaching to the company’s internal QA Person / Dept. relating to implementation strategies and/or the fine details within each QA requirement.

Depending on the situation, and the number of personnel requiring the training, these services can be performed either at the client’s facilities, or online / conference call using media such as Skype or GoToMeeting.

Upon the successful completion,  we provide Certificates of Training (C of T) suitable for framing. We can also provide multiple choice (aka: “multiple guess“) exams.

We have found that the more training that is provided – especially at the beginning stages of the QA Implementation process, the more the client can assist in the implementation. The end results are then much higher buy-in by staff & management, thus a more practical / efficient system, and less reliance on the consultant (and therefore less fees the consultant has to charge).

Why use a QMS consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada


Leave a Reply

ICS in Canada

Quality Assurance

Click to open a larger map

Regulatory Affairs consulting

Request a Quote from us

IP Blocking Protection is enabled by IP Address Blocker from LionScripts.com.