AUDIT DAY-IS HERE

    The Big Day! Certification   Audit Day…is here.

Audit Interview Do’s And Don’ts

Do…

1. Be polite, but limit casual conversation. The auditor is not your best friend of 30 years!

2. Answer questions completely, directly, and honestly with supportable facts. Steer clear of opinion.

3. Respectfully disagree when appropriate; ask for clarification.

4. Offer responses of “I do not know” or “I do not remember,” if appropriate, followed with when you will have the information or a referral to the correct subject matter expert.

5. Keep an inventory and a copy of anything you provide the auditor.

6. Show only one record at a time, if possible.

7. Correct any errors in speaking as soon as possible to avoid miscommunication.

8. Note any questions you were uncomfortable answering or would have answered differently in retrospect.

9. Conduct a short daily internal debrief during the audit.

10. Expect what you say to be documented. There is no such thing as “off the record” in an audit.

Don’t…

Misrepresent the truth or leave out important facts.

Correct a colleague in front of the auditor.

Correct documents when reviewing them with the auditor.

Guess or make up an answer.

Volunteer more information than necessary. Less is more…when asked a question.

Feel like you have to fill dead air. QUIET IS GOOD ON THIS DAY!

Question the auditor’s authority, argue, or raise your voice.

Agree to or volunteer to change a policy or procedure during the audit.

Refer to uncontrolled documents.

 Douglas H. Clark    cGMP Brief Technical Experience Overview:

SUMMARY:

Goal-oriented, Quality & Manufacturing/industrial leader with hands-on experience and customer satisfaction, and budget for private companies and Fortune 500 companies including 3rd party cGMP contract manufacturing experience.

Doug has spent over 37 years working in: large pharma, immunotherapy, food & beverage, (HACCP Certification, from AIB International), (Hands-on experience with SQF), packaging, biotechnology, and medical device. He has hands-on experience with: working under ISO, FDA, DEA regulations, and IATF standards.

AREAS OF EXPERTISE/CORE COMPETENCIES:

· ISO 9001:2015/ISO 14001

· ERP Systems/$350MM Projects

· Green Belt 6 Sigma, Villanova

· Lean Manufacturing/HACCP/SQF

· Gap Audits, First time Certification assistance for:/ISO 13485/SQF

· Meets Tight Deadlines

· Regulatory/FDA Inspections

· Packaging/Labeling/Cold Chain

· Optimizing Processes

· Cold Chain/Supply Chain

ISO/SQF/-Achievements:

· Helped a Packaging/Kitting company obtain ISO 13485:2016 first-time certification for them. Operation- High-volume cGMP facility dedicated to offering contract manufacturing services. Customers are top leading testing laboratories/and medical device companies.

· Successfully helped the newest State-of-the-Art PAPER CUP FACTORY IN THE U.S.A achieve (SQF), Safe Quality Food certification. First time certification for them.

A high-volume, high speed paper cup/lid factory that included: Raw paper loaded into high technology cup forming machines, as well as thermoforming lid machine.

Doug helps companies prepare and pass Certifications. 

ISO certification can help with: access to new markets, and more business. Helping improve your company's credibility and identity. ISO is globally recognized standard for quality in the medical device industry. Implementing ISO will have benefits for your organization. Although changes in your QMS will take immediate additional efforts, the results of having ISO will provide you with many benefits in operations, sales, and customer satisfaction. 

The goals of ISO implementation are focused on the customer needs rather than focusing on the individual goals of the department. This will help get new customers for business and boot the revenue. 

THE PRESTIGE AND ENHANCED EFFICIENCY ASSOCIATED WITH ISO ARE ENOUGH TO JUSTIFY BEING CERTIFIED.

A little about Doug:

37 years’ experience in the biopharmaceutical industry, Doug has participated in many aspects of Quality Assurance, and Manufacturing Operations. Doug is able to leverage his unique industry background in the biotechnology industry to oversee and manage daily quality and manufacturing operations to ensure timely and quality completion of important cGMP activities. Doug is flexible, and applies a data-driven, risk-based approach to the implementation of Quality Systems. Doug is knowledgeable in the areas of biopharmaceutical cGMP manufacturing, contract manufacturing operations, aseptic processing, startup and plant operations, small molecule/large molecule experience, clinical/cold-chain packaging, and cGMP quality operations. Specific Quality System strengths include batch record review, performing audits, QA investigations, qualification of vendors/suppliers, cGMP startups, and clean room operations for: FDA regulations, ISO 13485, and ISO 9001:2015.

● Successfully led high profile 24/7/365-day operations for cross-functional quality/manufacturing teams and provided strong management skills to ensure that key risks and opportunities were identified, captured, and presented in an unbiased way. Strong management expertise with a diverse background investing in people and coaching and developing staff (AQS Solutions, ISO 9001:2015/ISO 14001:2015 Integrated Auditor Training). 

● Drug products/products: OP-1 medical device, FDA licensed Insulin, cell culture-based products, First-of-Its Kind immunotheraypy new cGMP facility startup experience, Small/large scale bioreactor startups, ISO 7&8 cleanroom experience, silicone injection molding, drug packaging, and single-use technology, and cGMP bioreactor plant startups. 21 CFR Part 210, 211, 820, ISO and IATF 16949.

CRAFT BEER BREWERY EXPERIENCE:

Sanitizing/CIP clean in place/SIP sterilization in place of brewery hoses/filtration equipment, stainless steel process equipment/vessels, tanks, SOPs management, non-conforming product management, spare parts management, metrology program management, temperature/parameter monitoring, bottle cleaning, bottle filling preparation/inspection, DO (dissolved oxygen), CO2- checks, color and bitterness checks inspection of filling lines, bottle capping inspections, label inspections, retention sample storage, and final weights/final packaging of bottles.

SQF- Safe Quality Food experience. 

The Safe Quality Food (SQF) Program is a rigorous and credible food safety and quality program that is recognized by retailers, brand owners, and food service providers world-wide.  

ISO/QMS implementation for a cGMP plant site based on VOC (Voice of Customer).  Achieving ISO 13485/9001:2015 certification resulted in increase customer base for companies.  

Experience with medical device kitting and packaging services. Fulfillment, supply chain, warehouse, logistics, distribution/cold-chain operations.

Responsibility includes assessing possible technology and CMOs to partner with.  I successfully obtained senior management buy in to re certify a clean room to ISO 7 standards versus previous ISO 8 standards.   This upgrade was based on VOC Voice of Customer and understanding of current customer marketplace. The investment for the recertification cost was far exceeded by new customer growth and sales within six months.   

• Developed and implemented operating policies and procedures across  multiple departments, continuously evaluating for improvements to  maximize growth and efficiencies.
• Responsible for technical oversight of CMOs.
• Responsible for internal batch record review, product release and batch trend analysis working closely with PD and other technical leadership departments.
• Responsible for the logistics, shipping and supply chain management.
• Identified other supply partners for the Company’s products.
• Worked with technical leadership and Quality to enhance the Quality Management System (QMS).
• Managed the relationship with suppliers to ensure manufacturing  continuity while maintaining adequate inventory levels and on-time  shipping, identification, oversight and management of CMOs.

Team member for a startup and cGMP efforts for a newly constructed multi-million-dollar immunotherapy clean room cGMP plant.  This facility was the first cellular immunotherapy facility approved by the FDA in the United States for this type of manufacturing. 

Immunotherapy new plant startup- My team delivered the first phase of a project on time and online in 14 months.  This included construction, procedures development, PM’s Preventive Maintenance programs in place, hiring and training department staff, PAI Preapproval Inspection responsibilities resulting in a successful FDA Inspection (zero 483’s for my areas of responsibility).  Led multi-million dollar building service contracts for large cGMP FDA approved Clean Room Facility.  

Operational Excellence - (Green Belt) Six Sigma certified. formal hands-on experience that helps to lean out processes, save time, cut redundancy and waste in order to increase efficiency and profits. (5Y, 5S, 8D, FMEA and other Risk Assessments, Process Flow Mapping, kitting and Kanban LEAN methodologies. 

Strategic planning and leadership experience dedicated to growing contract manufacturing services that provided superior cGMP services and first-class customer service.  

Contract Manufacturing -   experience includes: cGMP Class 100; Class 10,000; and Class 100,000 clean room manufacturing; microbiology testing labs; characterization services; media; buffer; microsphere manufacturing, bioreactor services; purification services; filling and labeling; services.  

Manufacturing and laboratory facility (BOD) Basis of Design experience.  Contract Manufacturing -  experience includes: cGMP Class 100; Class 10,000; and Class 100,000 clean room manufacturing; microbiology testing labs; characterization services; media; buffer; microsphere manufacturing, bioreactor services; purification services; filling and labeling; services. Clean room setting-Custom labeling, packaging and kitting experience. 

Operations - Operations and Development experience encompassing: FDA commercial FDA approved drugs - OP-1 Med Device, tPA, PROVENGE.  Vial thawing and initial culture, T-flasks, roller bottles, shaker flasks, cell bags, single-use bioreactors, single/double use sterile tubing assemblies, silicone molded and over molded sterile assemblies, hollow fiber bioreactors, ceramic core bioreactors, high density perfused cultures, (pioneered by Verax microcarrier fluidized-bed bioreactors”), large scale SS perfusion and stirred bioreactors, media preparation; buffer and reagent preparations, clarification (MF/UF, centrifuge, depth filtration), chromatography, lyophilization, and bulk aseptic filling.  

Process Development/Technology Transfer - Cell culture and bioreactor optimization studies in order to adapt media formulation, buffers, and reagents to the cell line to achieve the highest product yield.  Cell Cryogenics - controlled rate freezing/master cell banking, storage and maintenance.  Operations Support Systems - CO2 incubators, Microscopes, centrifuges, autoclaves, depyrogenation ovens, Gamma sterilization, parts washers, Biosafety Cabinets, filter integrity testers, freezers, refrigerators, warehousing support, Compendial Water Systems, Clean Steam, CIP/SIP systems (large scale), critical gas systems, process control systems, HVAC, Classified Environments, and Building Management Systems.  

Doug has hosted/led over 250+ different types of inspections/audits in 37+ years.  These include: Agency FDA inspections, PAI rehearsal inspections, supplier audits/and customer audits, and ISO certifications. 

EDUCATION/CERTIFICATES:

● B.S., Indiana Institute of Technology, Fort Wayne, Indiana, 2004.

● Ten professional continuing education certificates completed to date.

● Six-Sigma Green Belt Certification from Villanova University.

● HACCP Certification, AIB International, Inc. AIB.

OMNEX 16949:2016/ISO 9001:2015 Certification Numbers: (QM2367, AU2364, &TL2368). Doug Clark

· IATF 16949 Lead Auditor Certification, OMNEX.

· IATF 16949 Core Tools Certification, OMNEX.

· IATF 16949 Customer Specific Requirements Certification, OMNEX.

● New Hampshire Community Technical College, Batch Culture of Recombinant tPA Secreting CHO Cells.

● University of Minnesota, Dr. Irving J. Pflug, Microbiology and Engineering of Sterilization Processes

● AQS Solutions, ISO 9001:2015/ISO 14001:2015 Integrated Auditor Training, Certificate #IA0391.