ComplianceOnline

Expert Profile


Anne E Maczulak
Principal Consultant, Acorn GLP Consulting

Anne Maczulak, PhD, RQAP-GLP is a Technical & Medical Writer for the pharmaceutical and consumer products industries. She has 30 years of experience as a bench scientist in R&D, participating scientist in GLP studies, and Quality Assurance professional. Anne began her career as a microbiologist for companies conducting FDA-regulated studies and EPA-regulated studies. She transitioned into consulting as an independent QA professional, auditing studies and facilities for GLP compliance as well as training employees in scientific communication. She now focuses solely on teaching scientists how to improve their communication skills for preparing SOPs, technical articles, and corporate communications.

Anne is a member of the Society of Quality Assurance Board of Publications and the American Medical Writers Association. She is the author of 14 books on microbiology and the environment.

Trainings by Expert

Reading Between the Lines: Dealing with Gaps in GLP Regulations
Category: All FDA Regulated Industry , FDA 21 CFR Part 11

What We Can Learn From Warning Letters
Category: All FDA Regulated Industry , FDA Audit and Inspection , Audit & Inspection-Role , All FDA Reg. based Audit , Life Sciences

FDA at the Door: Ten Essential Steps for Inspection Success
Category: All FDA Regulated Industry , FDA Audit and Inspection , Audit & Inspection-Role , All FDA Reg. based Audit , Life Sciences

Best Practices in GLP Final Reporting and Study Closure
Category: Laboratory Compliance , All FDA Regulated Industry , All FDA Regulated Industry , Quality and Safety , Laboratory , GLP & Other Best practices , Best Practices & GXPs , Life Sciences

Clearing up Roles and Responsibilities in the GLPs
Category: Laboratory , GLP & Other Best practices , Life Sciences

Good Documentation Practices for GXPs
Category: All FDA Regulated Industry , Documentation and IT , Quality and Safety , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences

Archiving GLP Records: How Archiving Makes or Breaks the Audit
Category: Laboratory Compliance , Laboratory , GLP & Other Best practices , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences , Documentation and Data Management

Test Article Management and Characterization for Drugs and Devices
Category: Laboratory Compliance , Quality and Safety , Laboratory , Life Sciences

Good Laboratory Practices for Bioanalytical Laboratories
Category: Laboratory Compliance , Laboratory , GLP & Other Best practices , Analytical Laboratory , Life Sciences

Managing GLP Studies in Non-GLP Facilities
Category: Laboratory Compliance , Quality and Safety , Laboratory , GLP & Other Best practices , Life Sciences