Anita Michael Email and Phone Number

Anita Michael joins RCA as an Executive Pharma Compliance Expert & Principal Consultant. She has 23+ years of global regulatory and quality experience, including 16 years’ operating globally as a Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. Anita has excellent interpersonal, empathetic communication and client management skills that enable her to skillfully coach and collaborate with clients at the highest levels of an organization and prepare them for successful FDA inspections (ANDA/NDA/BLA/PMA Pre-Approvals) and global regulatory and quality assurance audits across Biotech, Biologics, Sterile Operations, Drug Substances, and 503A/B. She has been Keynote Speaker for the Pharma Industry and internally to the FDA throughout her career.Anita experience includes positions as Vice President of Quality Assurance, Regulatory Affairs and Validation, as well at the Executive Director Level in Quality Assurance including numerous years as a Principal Consultant for QA and Regulatory. She is specialized in 6 System Inspection Readiness, CGMP training, Remediation, Compliance, Consent Decree, Warning Letter, FDA 483 responses to the FDA and Global Regulatory Agencies.She has reviewed and helped design innovative modern corporate quality systems, advanced modern manufacturing facilities for global pharmaceutical companies worldwide. She specializes in preparation, remediation and designing of training for individuals at all levels of an organization. She has successfully led multiple QA teams and provided hands on trainings, mentoring and enhanced company quality management systems throughout the lifecycle of the product. She is expertly versed in the Food Drug and Cosmetic (FD&C) ACT and current Good Manufacturing Practices (CGMPs), 21 CFR 210, 21 CFR 211, CFR 600 and Part 11 requirements and the practical application to assure a company operates in a state of control and has assessed over 300+ pharmaceutical companies worldwide .

Global GMP Quality Assurance and Compliance Pharmaceutical Quality Systems (PQS) ConsultingPrepare for FDA PAI and CGMP Inspections across all product lines. Biotech, Biologics, Sterile & Non-sterile, API, Finish Fill, Solid Oral., 503 and Data Integrity Audits. As a global industry leader, former FDA Pharmaceutical Expert, FDA Pre-Approval Manager and Industry professional I have extensive expertise in FDA's current inspection techniques and CGMP regulations with real-life application. Global GMP, LLC are experts in Mock FDA Audits, remediation, GAP assessments and improvements for your quality system. Organizing inspectional critical documentation, including building and maintaining a content repository is essential. Be prepared for your internal, external audits and supplier qualifications, while operating in compliance, by preparing for the US FDA and Global Audits with a Robust 365 Day Inspection Readiness Plan. Operate a compliant CGMP PQS & FDA Six Quality Systems for successful CGMPs and Global Regulatory Authority approvals. Being prepared is key to avoid time consuming, costly quality and regulatory mistakes that can lead to FDA 483s; Warning Letters, Consent Decrees, Recalls, product SISPQ problems as well as compliance confusion that can impact your industry reputation and company's bottom line. CGMP Audits Performed Globally: • Inspection Readiness 365• QMS Process & Procedure Development• GAP Assessments• QMS Remediation• Supplier Audit• Quality Control Unit Buildout & RemediationNon-Conformance & CAPA Management:• Non-Conformance/Deviation Investigation Management • Process Analysis & Enhancement for Validation & Qualification• Investigation, Action Plan, & Effectiveness Check Performed • KPI Track & Trending Regulatory Compliance:• CGMP Review for BLA; NDA; ANDA; PMA • FDA 483 Observation/Warning Letter Responses & Remediation• PAI & Inspection Readiness• Internal Audit & Remediation Services• CMC sections

SUMMARY Duties, Accomplishments and Skills:At the Executive Level, oversaw and managed the Global Quality Assurance, Regulatory Affairs and Validation Departments for manufacturing of CGMP Sterile Injectable Product Lines. Designed and maintained the Corporate Pharmaceutical Quality Systems, site policies, procedures, ANDA, DMF submissions and ensured the facility operated in accordance with US FDA CGMPs, global (MHRA); EMA; HC; ISO; WHO), local regulatory requirement in accordance with ICH Q5-Q13 & 503A/B. Designed and operated the company complaint CGMP Training Program and global Supplier Qualification Program. Provided extensive knowledge and site training in global CGMPs and Compliance requirements for successful compliance outcomes.• Oversaw and managed the Corporate wide QA Pharmaceutical Quality System for API and Sterile Injectable manufacturing. • Oversaw and managed the Corporate wide Regulatory Affairs and Validation Department. Led management practices and improvements to always ensure site inspection-readiness for sterile injectables & APIs per CGMPs. • Identified and corrected issues early in the ANDA & DMF submission process that could potentially impact product launch. • Determined ANDA & DMF submission requirements and coordinated plans and timelines with Project Management and FDA expectations.• Led organization through regulatory due diligence and keeping ahead of domestic US FDA and international regulatory requirements and changes within the quality & regulatory registration processes.• Led in partnership with Quality Assurance, Regulatory, R&D, Commercial, Legal, Operations, Manufacturing and Finance, stakeholders to develop and implement plans to maximize reputation and positive outcomes with FDA, health authorities and industry partners.• Managed a team of highly technical QA and RA Directors, QA Managers, SMEs and the Validation Department.• Multidisciplinary QA/RA responsibilities and influence across business acumen.

SUMMARY Duties, Accomplishments and Related Skills: This position provided support during Quality regulatory inspections, internal audits for quality assurance and CGMP operations. Worked to ensure that all identified content is organized, current and readily accessible in the event of an inspection or audit purposes. For the PQS reviewed and approved BIOTECH and Biologics for Cell Banking; Upstream Manufacturing (Cell Growth and Crude Protein Harvest); Downstream Manufacturing (Purification and Formulation); Process Performance and Product Quality Monitoring (Nonconformances, deviations, errors, and atypical events) low bioburden and sterile finish fill monitoring. • Led department leaders to build an inspection readiness capability across the large global organization. • Oversite of, complaints, adverse drug experience reporting, unapproved drug issues, or post-approval reporting violations (e.g., submitting application supplements, BPDRs)• Led management practices and improvements to always ensure site inspection-readiness globally for sterile biotech injectables, biologics and drug substances per CGMPs. • Ensured quality assurance and regulatory observations are adequately addressed and completed adequately and on schedule. • Provided direction and oversight for Inspection Readiness Preparation for Global Regulator Bodies. • Used benchmark leading practices and recommend improvements to make IOPS inspection ready. • Maintained and organized inspection readiness content, including building and maintaining a content repository.

SUMMARY Duties, Accomplishments and Related Skills: For biotech, biologics, sterile drugs, 503 A/B Pharmacy Compounding, non-sterile drugs, combination products, APIs and biopharmaceuticals reviews, evaluates and provide CGMP assessments for pharmaceuticals. Evaluates aseptic processing and environmental monitoring programs. For solid oral dosage forms, suspensions and solutions evaluate and provide CGMP expertise. Project Leader for inspectional readiness and remediation expertise. • Managed and led teams of Principal and Senior Consultants for remediation of CGMP and compliance. • Experienced expertise in API and finished pharmaceuticals, sterile, solid oral dosage, suspensions, biotech, combination drug devices assessments and evaluating CGMP 21 CFR 210, 211 and 21 CFR 820, ICH Q5-Q13, ISO and ANSI. • Expertly versed in application of 21 CFR 4.4(b)(1) (drug CGMP-based streamlined approach) and 21 CFR 4.4(b)(2) (device QS regulation-based streamlined approach). • Reviewed technical reports, process validation, CAPA, investigations, complaints, change control, APRs and SOPs for adherence to CGMP and International Regulations (MHRA); FDA; EMA; HC; ISO; WHO).• Ensured readiness preparation for FDA Pre-Approval Inspections, FDA Post Approval Inspections, and Post Market Approval Inspections. • Led successful NDA; ANDA and BLA FDA application approvals for midsize and larger biotech and pharmaceutical companies.

SUMMARY Duties, Accomplishments and Related Skills:Oversaw drug program and directed teams of Investigators, Compliance Officers and CDER SMEs for sterile drugs, non-sterile drugs, 503A/B, combination products, APIs and biopharmaceuticals. Served as Lead Expert in charge of for FDA 483’s, Cause and Follow Up Regulatory CGMP Inspections and Consent Decrees. Acting FDA Pre-Approval Manager, Served as Senior Expert Member of Pharmaceutical Inspectorate Level III for International Inspections. Served as Pharmaceutical Lead Technical Expert and Advisor to Senior FDA Officials throughout Agency. Expertise in Data Integrity requirements and Part 11 Compliance requirements. Reporting into Drug Manufacturing Product Quality (DMPQ) & Office of Regulatory Affairs (ORA). Conducted hundreds of Pre-Approvals, Post-Approval, CGMP Inspections, joint international inspections. • Conducted joint inspections w/ EMA, Health Canada under the MRA (Mutual Recognition Agreement). Expertly versed in CGMP 21 CFR 210, 211 and 21 CFR 820 21 CFR 4.4(b)(1) (drug CGMP-based streamlined approach) and 21 CFR 4.4(b)(2) (device QS regulation-based streamlined approach). Trained and proficient in ICH Q5-Q13. • Conducted 300+ advanced inspections & company evaluations in biotech, drug, sterile processing, PAT & QbD Applications.• Pharmaceutical industry expert in CGMPs, FDA regulations.• Provided Technical Review of Corrective Action Responses to Form FDA 483 Observations & reviewed Warning Letter responses & performed Risk Assessments.• Worked with exterior health authorities HC, EMA, CNMPA, HJ, WHO, during global drug events & drug crisis.• Subject Matter Expert (SME) for FDA pharmaceutical regulations & drug applications.• Reviewed onsite inspections & compliance review for corrective actions for FDA Untitled Letters, Warning Letters & Injunctions.• FDA Pre-Approval Manger that Led & managed teams of Investigators for Inspection; NDA; ANDA;DMF & BLA reviews & approval.

SUMMARY Duties, Accomplishments and Related Skills:Under the Executive Director of Regulatory Operations in the Vaccine Division, prepared and reviewed Investigational New Drug applications (IND), New Drug Applications (NDA) and Biological License Applications (BLA) amendments PAS, CBEs and Annual Reports in accordance with FDA Regulations and guidance and in compliance with internal GlaxoSmithKline SOPS. Assured 21 CFR § 314.1 and § 210; §211 and ICH Compliance requirements. • Coordinated assembly of all maintenance of IND submissions which included investigator documentation, IND information amendments/ general correspondence, advertising promotional materials. • Reviewed all maintenance submissions for adherence to established quality standards. • Maintained tracking information on all maintenance submissions and files documents as appropriate.• Provided periodic updates on IND, BLA and NDA submission work to management.• Reviewed Prescription Information for panel reviews and submission to FDA.