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2019 Annual Pharmaceutical GMP Training Program; Comprehensive Training on the Most Up to Date FDA & Global GMP Requirements and Best Practices

8-Part Live Training Program

Instructors: Kim Huynh-Ba Biography>>> & Peter Calcott Ph.D. Biography>>>

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Click Here to Register for this Live Training Program ►


A knowledgeable, experienced, and well-trained workforce plays a vital role in manufacturers attaining compliancy with Good Manufacturing Practices (GMPs) in the Pharmaceutical and allied industries.

FDA and other global regulatory agencies focus intensely on GMP compliancy, patient safety and product quality fundamentals. As per 21 CFR211.25 Personnel Qualifications and [ICH Q7 Section 3.12], training in GMPs is a requirement for pharmaceutical companies, and shall be conducted by qualified individuals on a continuing basis with sufficient frequency to assure that employees remain familiar with Current Good Manufacturing Practices (cGMPS) and remain competent in their job tasks and responsibilities.

Leading companies in the industry recognize the importance and contributions of well-informed and well-trained employees to the company’s performance and overall regulatory compliancy. However, designing and delivering the appropriate annual GMP training program in order to provide the employees with the most up to date GMP requirements can be challenging. Pharma Webinars has developed this concentrated 8-Part Annual GMP training program with qualified experts to assist you with the delivery of an effective annual GMP training to your personnel.

This intensive instructor-led annual GMP training series will consist of 8 live training sessions of 2 hours followed by 30 minutes of live Q&A each. It will include over 20 hours of live presentation and Q&A delivered periodically over the course of 4 months. The method of delivery proves effective in providing trainees with ample time to absorb, process, and put to use the information learned, and then return to the next session with any questions, as opposed to condensing this intensive training program’s curriculum into a short seminar, and thereby saturating the audience with an overload of information. Trainees will leave the course with a clear understanding of the requirements of US GMP and an appreciation of European GMP.

The design and preparation of this program’s content is a result of years of practical industry experience on the part of the presenters, Peter Calcott Ph.D. and Kim Huynh-Ba, ensuring that trainees will learn about GMP and how it is applied in a manufacturing operation as well as achieving a clear understanding of the US and EU GMP regulatory requirements.

The complete course agenda detailing each individual session can be found below.

Part 1: Quality Management System (QMS) – The New FDA, EU and Global Regulatory Requirements, Maintaining the Validated State and Driving for Consistency

Live, Interactive Training Webinar

Date: Tuesday March 12, 2019
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Peter H. Calcott Ph.D.

In the first part of this comprehensive GMP live training program, we are going to focus on the building blocks of the Quality Management System (QMS). Those building blocks are to assure that operations are in control and maintained in their validated state. It involves systems of checks and balances, methods of measurement to detect disturbances and systems to assure that changes introduced deliver improvements or are at least neutral in their effects. All of this is to assure that the products made are what was developed and promised to the regulatory bodies and what is best for the patient. The philosophy is that quality must be built in rather than tested in.

In Part 1, we will describe the building blocks that you will need in place which are described in ICH Q7 – GMPs for Active Pharmaceutical Ingredients and ICH Q10 – Pharmaceutical Quality Systems, which is based in ISO 9000. These include the overall Quality Philosophy defined in Quality Manuals, Quality Polices and Quality Planning; it includes the Document Management System, Personnel Learning and Development and the role Management plays in setting the culture to assure it is executed.

In a modern QMS, decisions are science and data driven with risk-based approaches (ICH Q9 – Quality Risk Management) incorporated. This entails controls over facilities and equipment, production controls, product assessments and controls, and materials controls.

Internal audits, self-inspections, quality metrics and annual product reviews are tools to assess how well we are doing versus our goals, which will allow course corrections to be made with continuous management assessment and actions. The change control system plays a pivotal role in assuring that all changes contemplated are both value added and appropriate as well as managed well to lead to success which ultimately is to focus on the patient.

Learning Benefits:
-Why we have a QMS to assure we build quality in rather than test in.
-How all of the agencies are approaching the new QMS requirements, what they expect and what they will be inspecting you for.
-How GMP regulations plus ICH Q7 and ICH Q10 are linked and how ICH Q9 ties into the new system requirements.
-How to evaluate and revamp your systems to meet the agency expectations and also streamline your operations.
-How to bring back science and data based thinking into the design and operation of your systems.
-How important an efficient change control system is in your operations.
-What systems are important to assure you maintain your validated state.
-Management’s increased role can aid in your long range and day to day operational efficiency.

Webinar outline and time breakdown:

Date: Tuesday March 12, 2019

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM What is a QMS and how it is important,
Overarching Philosophy of Quality,
Have the agencies changed direction?
The basic building blocks of a QMS,
People, policies, procedures and paper,
10:30 AM Break
10:40 AM Facilities, process and product control,
How to measure performance success – the tools,
The key role of change control,
What are the signs things are not going right?
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 2: Quality Management System (QMS) – Handling Deviations and Out-of-Spec (OOS) Investigations Based on the Latest FDA, EMA and Global Regulatory Requirements

Live, Interactive Training Webinar

Date: Thursday March 14, 2019
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Kim Huynh-Ba

Quality Management System (QMS) will ensure that the quality for drug product is maintained throughout its expiration dating. In this part of the GMP live training series, we will discuss how to handle issues when things are not going as expected. Inadequate documentation of incidents and investigation of deviations or Out-of-Specifications continue to be the major part of Warning Letters. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS investigations. Lack of consistency and ineffective root-cause analysis will lead to error and expensive laboratory activities. This session will discuss the Guidance for Industry on OOS/OOT Investigation and industry best practices of investigation process, and how CAPA can be determined.

In addition, this live session will also introduce other monitoring system such as the complaint and recall programs. In order to maintain QMS, the change control program must also be established to ensure that the manufacturing and testing of the product is maintained in the compliance state.

Learning Benefits:
-Understand regulatory expectations for OOS investigation.
-Build ruggedness into analytical procedures to prevent OOS occurrences.
-Building compliance into the investigation process and minimize OOS.
-Discuss the Complaint/Recall programs.
-Understand key issues of Change Control program.
-Define and monitor Corrective and Preventive Actions.

Webinar outline and time breakdown:

Date: Thursday March 14, 2019

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM Understand regulatory expectations of reporting deviations,
Review of warning letters related to OOS/OOT,
OOS investigation process,
Phase I: Laboratory Investigation,
Phase II: Full Scale OOS Investigation,
Conclusion and Documentation,
10:30 AM Break
10:40 AM Determine follow up actions and CAPA,
Change control process,
Overview of the complaint and recall programs,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 3: Quality Management System (QMS) – The New QMS Paradigm Explained

Live, Interactive Training Webinar

Date: Tuesday April 9, 2019
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Peter H. Calcott Ph.D.

The third part of this live training program will focus on the significant changes that the FDA, EMA, Japanese authorities and other countries have been driving over the last decade. All agencies have recognized we have been driving our operations to the mantra of what does the agency want? We have become an industry that is more interested in “check the box of compliance.” Now the agencies have told us what they want. They want us to be data and science driven. They want us to tell them what we will do and show them why it is the right thing to do. We are at a crossroads of taking back our industry and controlling our own destiny again.

In Part 3 we are going to focus on the building blocks that you will need in place. Some of them are in the Guidances already while others are on the way. Some of them may be implemented in your operations but not all, I hasten to say.

ICH Q7 – GMP for Active Pharmaceutical Ingredients is the cornerstone of the concerted GMPs accepted worldwide. This is augmented by ICH Q10 – Pharmaceutical Quality Systems. This is based on ISO 9000 and includes a drive for continuous improvement (CI) which is built on science based and data driven decisions. Included is the active participation of management in driving for improvements not only to our products and processes but also our QMS. A key cornerstone of CI is an effective Corrective Action and Preventive Action (CAPA) process.

This science driven and fact based decision making cannot be successful without considering the lifecycle of the product and process. ICH Q8 (Pharmaceutical Development) and Q11 (Development and Manufacture of Drug Substances) deal with the modern approaches to development of products and processes. In order to arrive at a product that is patient focused and a process that yields the product consistently, we have to be ruthless in the development cycle and only focus on high value added work. The tools of Quality Rick Management (ICH Q9) are critical to differentiate the relevant from the irrelevant in process design. The management of the lifecycle activity is beginning to take shape with the latest ICH Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The concept paper is out and the first draft will follow soon.

Certain other systems are critical in this new QMS paradigm. Change control becomes a critical element of the development cycle, so the system must be fast and nimble in development versus the stolid ponderous of commercial. The internal self-inspection program that most view as a check to assure everything is in compliance can take a new role as a source for CI looking for improvements and proposing best practices they have seen elsewhere. The Annual Product Review blossoms into a CI tool, where trending and interpretation lead to improvements.

Learning Benefits:
-How all of the agencies are approaching the new QMS requirements, what they expect and what they will be inspecting you for.
-How GMP and ICH Q10 are linked and how ICH Q9 ties into the new system requirements.
-How lifecycle management for products and processes and your QMS are tied together through Knowledge Management.
-How to evaluate and revamp you systems to meet the agency expectations and also streamline your operations.
-Learn what the new ICH Q12 may very well say and how you can be ahead of the game.
-Management’s increased role can aid in your long range and day to day operational efficiency.

Webinar outline and time breakdown:

Date: Tuesday April 9, 2019

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM The new QMS paradigm and what it contains,
ICH Q10 and its implementation,
Tying ICH Q9 into the operations,
Product Life cycle and what it entails,
Knowledge management – its value,
10:30 AM Break
10:40 AM Systems as they evolve over the life cycle,
Fueling the continuous improvement process,
Key role of an effective CAPA process – how to make it serve you,
Self-Inspection and APR in a new light,
The new ICH Q12 – Product Lifecycle,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 4: Facilities and Equipment – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities to Best Practices

Live, Interactive Training Webinar

Date: Thursday April 11, 2019
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Peter H. Calcott Ph.D.

In the FDA, EMA and most regulations, very little is said to guide you in what they expect of you with respect to design, construction, commissioning and start-up of facility, utility or equipment operations. Regulations are more focused on the output and operational aspects including the qualification and validation of activities. So many professional societies (PDA, ISPE) have taken the lead to aid practitioners to do the job right. But these are not regulations or even guidance, they are the industry’s interpretation of how to get to the finish line with minimal incidents.

In this Live Webinar, we will walk through the major areas of a plant, including the facilities, utilities and equipment in a critical manner to link best practices to the overall expectations of the agencies. That is the facilities, utilities and equipment design, construction, commissioning and start-up to the objective of assuring that they will lead to successful operations to yield consistent, reliable production free from cross contamination: the overall objectives of all regulatory bodies. We will focus on the qualification of these systems to assure this contributes to successful operations through the lifecycle of the plant and its operations. We will discuss strategies to operate efficiently, yet compliant in a risk based approach driven by data and scientifically driven means.

Learning Benefits:
-The expectations of the FDA and EMA and other regulatory bodies with respect to design, construction, start up and commissioning of facilities and utilities.
-How to maximize the output of your validation and qualification activities for your facilities, utilities and equipment yet minimize the input or work involved.
-How to tie the qualification processes to routine operations in an efficient and compliant manner including calibration and maintenance and periodic assessments of the qualified state of systems.
-Where companies fail to deliver a compliant systems putting their operations and compliance state at risk.

Webinar outline and time breakdown:

Date: Thursday April 11, 2019

Time*
9:15 AM Log In Period
09:30 AM Introduction
09:40 AM What exactly are the agencies requiring: what do the regulations mean?
Linking design, construction and procurement to operations,
The linkage of Quality, cost and time – which two do you want?
Mechanically complete – an oxymoron,
Start-up and commissioning a precursor to qualification,
Common pitfalls at the juncture of qualification,
10:30 AM Break
10:40 AM A critical look at facility qualification,
Challenges with utility qualification,
One size fits all for equipment qualification,
Conclusions,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 5: Latest FDA EMA & Other Regulatory Requirements of Pharmaceutical Manufacturing; from Manufacturing of Bulk Drugs to Finished Product Including Packaging and Labeling Activities

Live, Interactive Training Webinar

Date: Tuesday May 7, 2019
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Peter H. Calcott Ph.D

The fifth module will focus on the areas of production from manufacture of bulk drugs all the way to finished product including the packaging and labeling activities. While these areas are characterized by an incredibly diverse set of operations encompassing a wide range of products and actives from very low molecular weight products such as water for injection and aspirin (MW 18 and 168) to large molecules such as Factor VIII (MW 400,000+), many of the challenges for GMP are very similar although the solutions to them may be different. In all cases GMP focuses on assuring we start out with the right materials, manufacture according to defined procedures and controls, and end up with a product that meets the patients’ requirements. This is described in ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and Q10 (Pharmaceutical Quality Systems). During these steps, we attempt to prevent contamination from the environment and other manufacturing steps and prevent product degradation.

In this live Webinar, we will describe the basic principles used to prevent contamination, degradation and assure control of our processes, and hence products. We will walk through the major steps in the process (bulk and drug product manufacture, and packaging and labeling steps) to explain the driving force and intentions of the GMPs to that end. While commercial operations require strict adherences to the GMP to assure consistency and control, we will describe how clinical manufacturing requires more flexibility to allow development to progress as we learn more about the product and process. We will describe how a modern approach to development (Quality by Design) can be an advantage to the ultimate commercial operations with the intelligent use of ICH Q8 (Pharmaceutical Development) and 11 (Development and Manufacture of Drug Substances). With the intelligent use of ICHQ9 (Quality Risk Management) and efficient Knowledge Management we will describe how processes can be transferred effectively setting the stage for process validation and continuous verification.

Learning Benefits:
-The expectations of the FDA and EMA and other regulatory bodies with respect to control of pharmaceutical manufacturing and packaging.
-How to develop and transfer technology from development to commercial operations effectively.
-What the GMPs really mean and why they say what they say.
-Why such different systems and technologies have such similar challenges to deliver a safe and efficacious product to the patient.
-What the challenges are in your operations and how to address them satisfactorily.
-Where companies fail to deliver a compliant operation putting their business and compliance reputation at risk .

Webinar outline and time breakdown:

Date: Tuesday May 7, 2019

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM The different operations, all with the same challenges,
What are the GMP challenges?
How the challenges are met in different cases,
GMPs in development versus commercial – how they are different,
Flexibility in clinical operations,
Caution in commercial operations,
10:30 AM Break
10:40 AM Linking development to commercial and knowledge transfer,
Specific challenges in bulk manufacture,
Challenges in drug product,
Packaging and labeling,
Where companies fail to deliver,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 6: Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements

Live, Interactive Training Webinar

Date: Thursday May 9, 2019
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Kim Huynh-Ba

The Pharmaceutical laboratories serve one of the most important functions in the manufacturing of drug product. Section I of 21 CFR 211 dictates the requirements for the laboratory controls, and many laboratories consistently received 483’s and Warning Letters indicating that implementation of these requirements is a critical issue with multiple QC laboratories. This session will review the key requirements for a pharmaceutical lab such as analytical validation and verification, GMP requirements for laboratory testing, the stability program. This live session will also introduce the pitfalls of the lab operations and how to establish a workflow to keep the lab in the compliance state.

Learning Benefits:
-GMP requirements of the pharmaceutical labs.
-Analytical Validation process and lifecycle management of analytical procedure.
-The use of USP monograph and procedure verification.
-The role of the stability program.
-Several pitfalls that typically found in a QC labs.
-Key areas to focus for lab inspection.

Webinar outline and time breakdown:

Date: Thursday May 9, 2019

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM GMP requirements of the pharmaceutical labs,
Analytical Validation process and lifecycle management of analytical procedure,
10:30 AM Break
10:40 AM The role of the stability program,
Several pitfalls that typically found in a QC labs,
Key areas to focus for lab inspection,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 7: Raw Materials and Components Management – Latest Regulatory Requirements including a Review of the EMA Falsified Medicines Directive, Food and Drug Administration Safety and Integrity Act (FDAsia), Drug Supply Chain Security Act (DSCSA), & Secure Supply Chain Pilot Program (SSCPP)

Live, Interactive Training Webinar

Date: Tuesday June 11, 2019
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Peter H. Calcott Ph.D.

Over the last ten years we have seen the landscape of the supply chain changing. Gone are the days when we only focused on the materials and product in the warehouse. Gone are the days when you could rely on the label on the product. Counterfeit drugs are out there and it’s a growing problem. Even your raw materials and components that you relied upon are no longer assured. Foreign and domestic manufacturers are running afoul of the regulations. You can either wait for disaster to strike or be proactive and assure it will never happen.

The regulators (FDA and EMA) have taken the bull by the horns and developed guidances, regulations and acts to guide you as you set up your systems. The approach is different but complementary. The progressive company learns from both and develops a strategy to assure that the product they make is assured and arrives in top condition at the patient.

We will cover the elements of assurance of the supply of raw materials and components and how the Europeans have approached it. When you make the product we will focus on how you can be assured that it arrives in the condition intended. This includes assuring the distribution network is secure and meets the product storage conditions. Managing third party manufacturers will be a key point so you can add confidence in your suppliers.

In this live Webinar we will walk through all the new regulations and what is contemplated in the future with details on what must be done and when. We will include best practices to investigate and correct issues discovered in your systems.

Learning Benefits:
-Where your supply chain is vulnerable and what to do about.
-What the latest challenges are and what the agencies are expecting you to do.
-The requirements of the EMA Falsified Medicines Directive and when the elements must be implemented.
-The requirements of the FDA Acts that have been recently passed including Food and Drug Administration Safety and Integrity Act (FDAsia), Drug Supply Chain Security Act (DSCSA), & Secure Supply Chain Pilot Program (SSCPP).
-How to prioritize what is the most critical and must be acted upon and what you can postpone.

Webinar outline and time breakdown:

Date: Tuesday June 11, 2019

Time*
9:15 AM Log In Period
09:30 AM Introduction
09:40 AM What is the supply Chain and modern Materials Management,
Where are the vulnerable steps,
What is the FDA and Canada proposing,
What do the Europeans want,
Harmonization of the two,
What to focus on,
10:30 AM Break
10:40 AM Building security in your raw materials,
Protecting the bulk substance and drug product in shipment,
Counterfeiting and the internet,
Managing CMOs,
Working with the regulators,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 8: GMP Requirements for Records and Reports – Documenting Your GMP Activities; Understanding the Vital GMP Requirements of a Documentation System

Live, Interactive Training Webinar

Date: Thursday June 13, 2019
Time: 9:30am - 11:30am ET (New York Time)
Instructor: Kim Huynh-Ba

In the GMP world, when things are not written down, they are not considered happening. Therefore, documentation system is extremely important to reconstruct and evaluate laboratory controls and to ensure product quality and safety. 21 CFR 211 Subpart J lists requirements on records and reports. Documentation provides both procedures and evidence of activities being complete according to the standard operation procedures.

This live session will discuss the requirement of a documentation system; define raw data, records and reports. It will also include key information to maintain data integrity and traceability.

Learning Benefits:
-GMP requirements for records and reports.
-Defining raw data, records and reports.
-Good Documentation principles.
-Data integrity and traceability.
-Establishing protocols and reports.
-Evaluating and storing analytical data.

Webinar outline and time breakdown:

Date: Thursday June 13, 2019

Time*
09:15 AM Log In Period
09:30 AM Introduction
09:40 AM GMP requirements for records and reports,
Defining raw data, records and reports,
Good Documentation principles,
10:30 AM Break
10:40 AM Data integrity and traceability,
Establishing protocols and reports,
Evaluating and storing analytical data,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


This comprehensive 8-Part live training program includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditors

Click Here to Register for this Live Training Program >>>

 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland

Clients: