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PDF Edition — $230
About the Authors
Max Lazar, Chemist, FDA Regulatory Compliance Consulting
Max Lazar looks back on an outstanding career within the pharmaceutical industry. For more than 35 years he was working with Hoffmann-La Roche. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7 Guidance. His more than 40-year career in the pharmaceutical industry includes numerous memberships in professional organizations and chairs of committees.
Christine Oechslein, Pharmacist, GMP-Praxis
As a freelance GMP trainer, Christine Oechslein provides internal GMP training for pharmaceutical companies, manufacturers of active ingredients and suppliers. She has worked in the pharmaceutical industry for many years. As a speaker for different event organizers and an author, she shares her GMP knowledge in the areas of process validation, GMP training and GMP in development.
Bernhard Gotter, Pharmacist, F. Hoffman-La Roche, Ltd.
Bernhard Gotter took up the position of QA Manager in inspection management at F. Hoffmann-La Roche in 2016. In the previous five years, he had worked at Bayer in quality assurance, auditing, supplier management and project management. During this time, he managed numerous audits, and organized and supported official inspections.
Who Will Benefit
- Quality control department
- Regulatory compliance department
- Auditors
- Consultants
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