A distinctly different consulting approach to advance your business interests.
Our consulting services include:
(A) Compliance Consulting - Quality Systems | Regulatory Audits | GMP Trainings
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle.
We design audit and corrective action plans to accommodate our client's needs, including MHRA, EMEA, and FDA regulations. During our audit process, we evaluate your existing quality systems, and provide an exact assessment on the company's various systems. We then recommend a plan of corrective action, which allows the company to achieve the quality assurance required by the respective regulatory agencies.
We provide cGMP training programs to fit for client needs from cGMP orientation new hires through annual cGMP Training on various cGMP Modules. Our new hire cGMP orientation is an overview of basic GMP concepts and emphasizes, to new employees, the importance of understanding and following government regulations.
(B) Validation Consulting - Equipment Validation | Process Validation | Computer System Validation | Cleaning Validation | Analytical Method Validation
We possess extensive knowledge in various Pharmaceutical manufacturing processes, computerized automated control systems, laboratory instrumentation & information systems, and qualification, validation & audit programs. We have qualified staff to assist clients in assessing and defining their compliance and validation requirements for various manufacturing systems and provides the necessary resources to achieve these objectives.
(C) Commissioning and Qualification
We provide an efficient, effective documented program that follows and complies with global regulations and guidelines. Our engineering project life cycle experience ensures that commissioning and validation issues impacting on the design phase of a project are fully considered and integrated at the start of a project. We provide consistent guidance for design, construction, and commissioning and qualification of manufacturing facilities. Our qualification efforts will help with sound and responsible interpretation of regulations which govern manufacturing operations.
Writing Ethical, Focused and Credible Internal Audit Reports
Speaker: Philip VassalloPrice: $285
Moving from an Operational Manager to a Strategic Leader
Speaker: Chris DeVanyTime: 01:00 PM EDT | 10:00 AM PDT
Location: New York
Logistics Channel Incoterms Standards
Speaker: Dr. Rossano V. GeraldTime: 01:00 PM EDT | 10:00 AM PDT
Location: New York
Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.