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Qualified training to increase staff competency

Professional Training Programs
Introduction to cGMP Annual GMP Training Good Documentation Practices
Auditing Fundamentals Advanced GMP Auditing Workshop How to Write Effective SOPs
Preparing for a Regulatory Inspection Pre-Approval Inspection Prep Computer Validation Basics
Change Control Calibration Fundamentals Introduction to ICH Q7 - GMP for APIs


Global Quality Alliance (GQA) can help update your staff's technical competence and expand their areas of knowledge and expertise, thereby increasing their value to the company or organization. Off-site training allows your staff, in the company of colleagues and peers, to become totally immersed in the subject being presented.

On-site training allows your staff to stay close to their areas of responsibility and quickly put their new information to work. Qualified trainers, with relevant industry experience, provide an excellent learning experience.

Global Quality Alliance can tailor training programs to meet your unique needs and can arrange on-site or off-site training on a variety of topics.

Please call or email us to discuss training needs or to schedule a training program for your staff.

Specifications

A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance should conform to be considered acceptable for its intended use.

Conformance to specifications means that the drug substance, when tested according to the listed analytical procedures, will meet the listed acceptance criteria.

Specifications are binding quality standards that are agreed to between the appropriate
governmental regulatory agency and the applicant.

(ICH draft guidance Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances)

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