Training and Technology Consulting
ATC, a recognized leader in Computer Based Training and cGMP Compliance Issues, has been helping clients respond to the challenges in the pharmaceutical industry for over 25 years. ATC has brought quality and innovation to both state-of-the-art pharmaceutical and biotechnology facilities worldwide from R&D through bulk production.
Our programs and capabilities begin in the classroom and transition to the laboratory and production floor. Each ATC program is designed to meet individual client needs while consistently addressing compliance and operational concerns.
Our validation staff are conversant with the wide variety of domestic and international rules, regulations and regulatory bodies including the FDA, MCA, HPB, other European national agencies and the relevant EEC directives. From regulatory proficiency to technical advancements, we provide on-site training including seminars and courses for both industry and academia.
ATC provides in-house programs which address:
FDA Pre-Approval Preparation
Preparation for an FDA Audit
cGMP’s and Regulatory Compliance
This is a representative list of some of the courses provided. A complete listing is available at our regional offices. ATC also offers training services in more specific areas, including programs that may be tailored to a client’s specific needs.
Job Training Assistance
Federal and state legislation has made it possible for clients to recoup a portion of the funds dedicated for training. ATC is proud to be nationally recognized as a both a federal and state qualified training provider.
Quality Engineering Manuals
It’s not just about training. Not anymore. Downsizing. Rightsizing. Reengineering. The blinding speed of change. And your employees - the ones you’re counting on to meet today’s demanding deadlines - are battling the front lines everyday.
There is a fine line between adequate training and building for your future. ATC offers services that support your commitment to continuous improvement including:
Of course, the vendor provided a manual and they even reviewed the set-up and breakdown procedures with a few key individuals. Since then, time has passed and people and things have changed. Now what? The answer: ATC Equipment Manuals. Clear. Concise. Complete with assembly diagrams, flowcharts and step-by-step guides. Eliminate costly delays in production due to incorrect equipment assembly. Remove the doubt; improve performance.
SOP’s and Operational Manuals
Have you taken a look at your procedures lately? Are they really functioning for you? Are they a value for new employee training and cross training of existing employees? Maybe not. Our quality engineering manuals are written with the end user in mind and are customized for your production equipment. Each section guides the user through all aspects of equipment operation in a step-by-step manner and utilizes practical, digital photos to illustrate each step. Reduce manufacturing deviations by providing a reference manual employees will want to use because it contains the content that counts in a form they understand.
Imagine a training program in which everyone has demonstrated the same skills, met the same objectives and has the same clear understanding of how a system works. Further, imagine you had documentation that outlined a clear set of requirements for certification from a company whose trainers specialize in engineering instruction. Stop dreaming. Let the certified trainers at ATC design a quality assessment system which not only meets your needs, but exceeds the new FDA and EU specifications.
Training Videos/CD ROM Packages
Consistency in performance. You want it. The world’s regulatory agencies require it. Still, there’s the bottom line and it’s not always cost effective to schedule an entire training session for one individual. A problem? Not with ATC Video/CD ROM training modules. Prepared during the on-site training process these modules provide a cost-effective method for meeting individual training needs, as well as equipment re-certification requirements. Quality in practice is an ATC standard.
Our customized training programs improve your company profitability by improving employee productivity. Everyone wins. Your people achieve their personal and professional best. Your company and your bottom line keep growing stronger.
The strength of any company is the ability and motivation of its workforce. ATC’s specialists are qualified, experienced professionals, most of whom have worked in the international pharmaceutical manufacturing industry.
Our group has successfully resolved compliance, consulting and validation issues ranging from individual equipment qualifications to full facility validation projects through consulting with clients regarding specific compliance issues and FDA presentations. ATC staff are accomplished in developing the content of the protocols (purpose, responsibilities, test methodology discrepancy resolution and acceptance criteria) to meet or exceed cGMP, FDA and other regulatory agency requirements for validation of equipment, systems and processes across the range of pharmaceutical, biotechnology, medical device, bulk drug and manufacturing applications. Dedicated specialists, supported by the expertise of the entire team, bring to our clients technical expertise in the latest trends and industry practices. ATC consultants work actively with professional organizations, vendors, regulatory agencies and other experts in technology development.
Qualities For Success
ATC’s staff training programs and Career Path Program distinguish our company from other validation groups. These programs enhance the group at the individual level and as a service provider for clients. Career Path Program Our Career Path Program fosters goal-oriented development and performance measures for our staff. The program also provides each person with an awareness of ownership in the business of providing quality services to our clients. We have found that our approach increases the development and caliber of our employee’s experience base and adds value to our client services.
BioPharmaceutical Awareness & cGxP Training
ATC of supports a BioPharmaceutical Awareness and cGMP Training Program for internal instruction of staff in both the Validation and cGMP Compliance Services group and the engineering disciplines working in pharmaceutical design engineering. Seminars are held once per month and cover aspects of Validation, cGMP Compliance, Process Engineering, Administrative (Project Controls and Contracts), etc. as related to our project work. Experts within ATC, selected vendors and outside authorities (FDA) have presented seminars in the past three years.
ATC issues to our field personnel sets of seminar handbooks covering over fifteen categories specific to equipment, facility and utility validation. Each seminar manual contains information relevant to cGMP compliance, industry standards, international compliance and regulatory considerations, sample validation protocols, overheads for presentation to site-assigned ATC teams and a final test which is graded and included in each employee’s training files.