GMP Training and Documentation for Pharma Manufacturers

20+ Years of Experience

Proven track record creating compliant training and documentation for regulated industries with stringent quality requirements. 

Compliance-Ready

Understanding of FDA regulations, ICH guidelines, and GMP requirements. We create documentation that satisfies auditors and inspectors. 

Manufacturing Focus

We understand pharmaceutical operations – from raw material receipt through finished product release – and create practical training that works on the manufacturing floor. 

Validation-Ready

Documentation designed to support validation activities, with proper version control, change tracking, and approval workflows. 

Training and Documentation For Pharmaceutical Operations 

Drug Substance Manufacturing  

API production training, process documentation, batch record procedures, equipment cleaning validation

Drug Product Manufacturing

Tablet/capsule production, sterile manufacturing, packaging operations, line clearance procedures

Quality Control/Quality Assurance

Laboratory procedures, testing protocols, out-of-specification investigations, change control documentation

Regulatory Affairs & Compliance

Audit preparation, inspection readiness, regulatory submission documentation, validation master plans

Fintech

Digital banking, payment processing, cybersecurity, platform training

Contract Manufacturing Organizations (CMOs)

Client-specific training programs, technology transfer documentation, multi-product facility procedures

Typical Pharmaceutical Projects We Handle: 

• Annual GMP training refresh and updates
• New equipment training and documentation
• Process validation protocols and reports
• Deviation investigation training
• Data integrity and 21 CFR Part 11 compliance
• Cleaning validation SOPs
• New employee GMP orientation programs
• Regulatory inspection preparation
• Technology transfer documentation
• CAPA system training

1. Discovery 

We work with your Quality and Operations teams to understand processes, regulatory requirements, and training gaps.

2. Design

We create training strategies and documentation plans that meet GMP requirements while being practical for manufacturing floor use.

3. Development

We build engaging training and clear SOPs using proven instructional design and technical writing methodologies.

4. SME Review & Validation

Your subject matter experts review for technical accuracy and regulatory compliance. We refine based on feedback.

5. Delivery & Implementation

Complete, validated, audit-ready deliverables with proper version control and training records.

 Relevant Background:

• 20+ years creating technical training and documentation
• PMP certified project management
• Principal consultant holds an MBA, a master's degree in Information & Communication Technology, and a bachelor's degree in English
• Experience in regulated industries (finance, healthcare, pharma, public sector)
• Section 508 compliance expertise
• SCORM and LMS integration experience

Our Role:

We are expert instructional designers and technical writers. We are not pharma experts, but we can work with your SMEs and regulatory experts to translate complex pharma and regulatory content into clear, engaging training, while ensuring accuracy and compliance.